Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).
Interventions
DEVICETrelegy Ellipta
Trelegy Ellipta with Furoate/Umeclidinium/Vilanterol
DEVICEStiolto Respimat
Stiolto Respimat with Tiotropium Bromide/Olodaterol
DRUGFuroate/Umeclidinium/Vilanterol
Furoate/Umeclidinium/Vilanterol
DRUGTiotropium Bromide/Olodaterol
Tiotropium Bromide/Olodaterol
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November 2019. The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication. * \>1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period * ≥40 years of age as of the year of the index date * Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period) * Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.
Exclusion criteria
* ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period * Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date * A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA * Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date \-- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication * Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date * ≥1 medical claim with a procedure code for lung volume reduction during the study period * Unknown age, gender, or business line, or unknown/other geographic region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Health Care Resource Utilization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | All-cause health care resource utilization. Annualized population averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.) Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| All-cause Health Care Resource Utilization: Inpatient Days | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | All-cause health care resource utilization: Inpatient days. Annualized population averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| All-cause Health Care Resource Utilization: Pharmacy Fills | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | All-cause health care resource utilization: Pharmacy fills. Annualized population averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as:(\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD-related Health Care Resource Utilization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.). Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD-related Health Care Resource Utilization: Inpatient Days | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization: Inpatient days. Population annualized averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD-related Health Care Resource Utilization: Pharmacy Fills | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD and/or Pneumonia-related Health Care Resource Utilization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of pharmacy fills is reported. Population annualized averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Pneumonia-related Health Care Resource Utilization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| Pneumonia-related Health Care Resource Utilization: Inpatient Days | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD or Pneumonia-attributable Health Care Resource Utilization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
| COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages for pharmacy claims are calculated as the (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Wald 95% confidence limits for this ratio used the Taylor expansion to estimate the standard error. |
| All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | All-cause health care costs were computed from the payer and patient perspective together. Annualized population averages of all-cause health care costs in each of the following categories is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs were calculated as: (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the date of the claim and 2020. |
| COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | COPD-related health care costs (HCC) cover the costs for medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of COPD-related HCC for the categories below are reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs = (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs are adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020. |
| COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of costs for categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020. |
| Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | These costs were calculated for medical claims with a diagnosis for pneumonia in any position. Annualized population averages of pneumonia-related health care costs for the categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020. |
| COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position, or pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages are reported and were calculated as=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Annualized population averages of COPD exacerbations for the categories below are reported: * Any COPD exacerbation * Severe COPD exacerbation (defined as an inpatient admission or an emergency room (ER) visit with a COPD diagnosis code in the primary position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position and a COPD diagnosis code in any position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position + an inpatient admission or an ER visit within ±7 days with a COPD diagnosis code in any position). Annualized population averages= (\[sum of all exacerbations for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization | Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365). | Percentage of patients with 30-day all-cause readmission after Chronic Obstructive Pulmonary Disease (COPD) hospitalization is reported. Hospitalizations were classified as COPD-related if they met either of the following 2 criteria: * ≥1 diagnosis of COPD in the primary position any time during the acute inpatient stay; or * ≥1 diagnosis of acute respiratory failure in the primary position and a diagnosis of acute exacerbation of COPD in a later position on the same claim during an acute inpatient stay. |
Countries
United States
Participant flow
Recruitment details
This was a non-interventional study using existing data from commercial and Medicare Advantage Part D (MAPD) beneficiaries, using administrative claims data for the period of 01 June 2015 through 30 November 2019.
Pre-assignment details
Only subjects that met all inclusion and none of the exclusion criteria were included.
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication. | 5,658 |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication. | 5,658 |
| Total | 11,316 |
Baseline characteristics
| Characteristic | Tiotropium Bromide/Olodaterol (TIO/OLO) | Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Total |
|---|---|---|---|
| Age, Continuous | 71.69 Years STANDARD_DEVIATION 8.69 | 71.75 Years STANDARD_DEVIATION 8.61 | 71.72 Years STANDARD_DEVIATION 8.65 |
| Race/Ethnicity, Customized Hispanic | 311 Participants | 281 Participants | 592 Participants |
| Race/Ethnicity, Customized Non- Hispanic Asian | 78 Participants | 62 Participants | 140 Participants |
| Race/Ethnicity, Customized Non- Hispanic Black | 731 Participants | 740 Participants | 1471 Participants |
| Race/Ethnicity, Customized Non- Hispanic White | 4015 Participants | 3815 Participants | 7830 Participants |
| Race/Ethnicity, Customized Other/unknown | 523 Participants | 760 Participants | 1283 Participants |
| Sex: Female, Male Female | 2846 Participants | 2866 Participants | 5712 Participants |
| Sex: Female, Male Male | 2812 Participants | 2792 Participants | 5604 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
All-cause Health Care Costs (Insurer + Patient Paid Amounts)
All-cause health care costs were computed from the payer and patient perspective together. Annualized population averages of all-cause health care costs in each of the following categories is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs were calculated as: (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the date of the claim and 2020.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 7321.14 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 7480.17 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 4334.68 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 1118.83 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 2986.46 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 10192.10 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 991.35 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 27103.58 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 16911.48 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 30434.63 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 18471.61 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 7858.06 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 3030.56 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 4827.50 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 1086.48 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 8139.51 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 1387.55 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 11963.02 dollars/year |
Comparison: Medical costsp-value: 0.06Weighted clustered linear regression
Comparison: Ambulatory costsp-value: 0.177Weighted clustered linear regression
Comparison: Office visits costsp-value: 0.834Weighted clustered linear regression
Comparison: Outpatient visits costsp-value: 0.121Weighted clustered linear regression
Comparison: Emergency room visits costsp-value: 0.159Weighted clustered linear regression
Comparison: Inpatient stay costsp-value: 0.289Weighted clustered linear regression
Comparison: Other medical costsp-value: 0.055Weighted clustered linear regression
Comparison: Pharmacy costsp-value: <0.001Weighted clustered linear regression
Comparison: Total (medical + pharmacy) costsp-value: <0.001Weighted clustered linear regression
Primary
All-cause Health Care Resource Utilization
All-cause health care resource utilization. Annualized population averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.) Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Office visits | 17.80 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Emergency room visits | 1.26 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Ambulatory visits | 32.54 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Outpatient visits | 14.82 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Other medical visits | 10.09 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization | Inpatient visits | 0.45 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Other medical visits | 10.48 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Ambulatory visits | 32.91 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Office visits | 17.57 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Outpatient visits | 15.42 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Emergency room visits | 1.39 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization | Inpatient visits | 0.48 visits/year |
Comparison: Ambulatory visitsp-value: 0.639Weighted clustered linear regression
Comparison: Office visitsp-value: 0.535Weighted clustered linear regression
Comparison: Outpatient visitsp-value: 0.337Weighted clustered linear regression
Comparison: Emergency room visitsp-value: 0.058Weighted clustered linear regression
Comparison: Inpatient visitsp-value: 0.192Weighted clustered linear regression
Comparison: Other medical visitsp-value: 0.176Weighted clustered linear regression
Primary
All-cause Health Care Resource Utilization: Inpatient Days
All-cause health care resource utilization: Inpatient days. Annualized population averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization: Inpatient Days | 4.30 inpatient days/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization: Inpatient Days | 4.68 inpatient days/year |
p-value: 0.313Weighted clustered linear regression
Primary
All-cause Health Care Resource Utilization: Pharmacy Fills
All-cause health care resource utilization: Pharmacy fills. Annualized population averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as:(\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | All-cause Health Care Resource Utilization: Pharmacy Fills | 59.39 pharmacy fills/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | All-cause Health Care Resource Utilization: Pharmacy Fills | 57.13 pharmacy fills/year |
p-value: 0.021Weighted clustered linear regression
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Annualized population averages of COPD exacerbations for the categories below are reported: * Any COPD exacerbation * Severe COPD exacerbation (defined as an inpatient admission or an emergency room (ER) visit with a COPD diagnosis code in the primary position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position and a COPD diagnosis code in any position; or an inpatient admission or an ER visit with a diagnosis code for acute respiratory failure in the primary position + an inpatient admission or an ER visit within ±7 days with a COPD diagnosis code in any position). Annualized population averages= (\[sum of all exacerbations for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Any COPD exacerbation | 1.02 exacerbations/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Severe COPD exacerbation | 0.28 exacerbations/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Any COPD exacerbation | 0.98 exacerbations/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Severe COPD exacerbation | 0.26 exacerbations/year |
Comparison: Any COPD exacerbationp-value: 0.205Weighted clustered linear regression
Comparison: Severe COPD exacerbationp-value: 0.454Weighted clustered linear regression
Primary
COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)
These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of costs for categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 2121.76 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 6811.63 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 1640.60 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 446.38 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 481.16 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 4729.11 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 448.83 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 14557.70 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 9828.60 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 17632.54 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 11065.38 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 2316.77 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 508.60 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 1808.18 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 482.53 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 7769.37 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 496.70 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 6567.16 dollars/year |
Comparison: Medical costsp-value: 0.057Weighted clustered linear regression
Comparison: Ambulatory costsp-value: 0.182Weighted clustered linear regression
Comparison: Office visits costsp-value: 0.083Weighted clustered linear regression
Comparison: Outpatient visits costsp-value: 0.245Weighted clustered linear regression
Comparison: Emergency room visits costsp-value: 0.386Weighted clustered linear regression
Comparison: Inpatient stay costsp-value: 0.115Weighted clustered linear regression
Comparison: Other medical costsp-value: 0.237Weighted clustered linear regression
Comparison: Pharmacy costsp-value: <0.001Weighted clustered linear regression
Comparison: Total (medical + pharmacy) costsp-value: <0.001Weighted clustered linear regression
Primary
COPD and/or Pneumonia-related Health Care Resource Utilization
Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Ambulatory visits | 9.01 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Office visits | 4.04 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Outpatient visits | 4.98 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Emergency room visits | 0.70 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Inpatient visits | 0.40 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization | Other medical visits | 4.36 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Inpatient visits | 0.45 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Ambulatory visits | 9.85 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Emergency room visits | 0.70 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Office visits | 4.19 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Other medical visits | 4.94 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization | Outpatient visits | 5.67 visits/year |
Comparison: Ambulatory visitsp-value: 0.017Weighted clustered linear regression
Comparison: Office visitsp-value: 0.098Weighted clustered linear regression
Comparison: Outpatient visitsp-value: 0.036Weighted clustered linear regression
Comparison: Emergency room visitsp-value: 0.894Weighted clustered linear regression
Comparison: Inpatient visitsp-value: 0.036Weighted clustered linear regression
Comparison: Other medical visitsp-value: 0.001Weighted clustered linear regression
Primary
COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days
Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days | 3.97 inpatient days/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days | 4.49 inpatient days/year |
p-value: 0.162Weighted clustered linear regression
Primary
COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills
Chronic Obstructive Pulmonary Disease (COPD) and/or pneumonia-related health care resource utilization (medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics). Population annualized averages of pharmacy fills is reported. Population annualized averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills | 15.48 pharmacy fills/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills | 15.08 pharmacy fills/year |
p-value: 0.037Weighted clustered linear regression
Primary
COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts)
These costs were calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position, or pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages are reported and were calculated as=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 517.27 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 4595.72 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 286.18 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 363.95 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 231.09 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 4729.11 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 153.87 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 10359.92 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 5630.81 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 12573.62 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 6006.47 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 623.53 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 242.99 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 380.53 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 130.00 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 4885.72 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 367.22 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 6567.16 dollars/year |
Comparison: Medical costsp-value: 0.483Weighted clustered linear regression
Comparison: Ambulatory costsp-value: 0.002Weighted clustered linear regression
Comparison: Office visits costsp-value: 0.123Weighted clustered linear regression
Comparison: Outpatient visits costsp-value: 0.003Weighted clustered linear regression
Comparison: Emergency room visits costsp-value: 0.17Weighted clustered linear regression
Comparison: Inpatient stay costsp-value: 0.582Weighted clustered linear regression
Comparison: Other medical costsp-value: 0.887Weighted clustered linear regression
Comparison: Pharmacy costsp-value: <0.001Weighted clustered linear regression
Comparison: Total (medical + pharmacy) costsp-value: <0.001Weighted clustered linear regression
Primary
COPD or Pneumonia-attributable Health Care Resource Utilization
COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Ambulatory visits | 4.20 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Office visits | 2.09 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Outpatient visits | 2.12 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Emergency room visits | 0.29 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Inpatient visits | 0.24 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization | Other medical visits | 3.82 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Inpatient visits | 0.25 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Ambulatory visits | 4.90 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Emergency room visits | 0.26 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Office visits | 2.14 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Other medical visits | 4.27 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization | Outpatient visits | 2.77 visits/year |
Comparison: Ambulatory visitsp-value: 0.002Weighted clustered linear regression
Comparison: Office visitsp-value: 0.42Weighted clustered linear regression
Comparison: Outpatient visitsp-value: 0.002Weighted clustered linear regression
Comparison: Emergency room visitsp-value: 0.304Weighted clustered linear regression
Comparison: Inpatient visitsp-value: 0.326Weighted clustered linear regression
Comparison: Other medical visitsp-value: 0.007Weighted clustered linear regression
Primary
COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days
COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days | 2.87 inpatient days/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days | 3.08 inpatient days/year |
p-value: 0.52Weighted clustered linear regression
Primary
COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills
COPD or pneumonia-attributable health care resource utilization: This utilization was calculated for medical claims with a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in the primary position or a diagnosis for acute respiratory failure in the primary position and a diagnosis for COPD, pneumonia, or acute bronchitis/bronchiolitis in a non-primary position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages for pharmacy claims are calculated as the (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Wald 95% confidence limits for this ratio used the Taylor expansion to estimate the standard error.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills | 15.48 pharmacy fills/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills | 15.08 pharmacy fills/year |
p-value: 0.037Weighted clustered linear regression
Primary
COPD-related Health Care Costs (Insurer + Patient Paid Amounts)
COPD-related health care costs (HCC) cover the costs for medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics. Annualized population averages of COPD-related HCC for the categories below are reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages of costs = (\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs are adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 2088.43 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 6681.35 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 1619.49 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 439.65 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 468.94 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 4729.11 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 426.02 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 14364.56 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 9635.45 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 17387.20 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 10820.05 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 2278.21 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 493.42 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 1784.78 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 455.87 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 7596.04 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 489.92 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Costs (Insurer + Patient Paid Amounts) | Pharmacy costs | 6567.16 dollars/year |
Comparison: Medical costsp-value: 0.066Weighted clustered linear regression
Comparison: Ambulatory costsp-value: 0.193Weighted clustered linear regression
Comparison: Office visits costsp-value: 0.117Weighted clustered linear regression
Comparison: Outpatient visits costsp-value: 0.25Weighted clustered linear regression
Comparison: Emergency room visits costsp-value: 0.431Weighted clustered linear regression
Comparison: Inpatient stay costsp-value: 0.129Weighted clustered linear regression
Comparison: Other medical costsp-value: 0.236Weighted clustered linear regression
Comparison: Pharmacy costsp-value: <0.001Weighted clustered linear regression
Comparison: Total (medical + pharmacy) costsp-value: <0.001Weighted clustered linear regression
Primary
COPD-related Health Care Resource Utilization
Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages of visits for each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (included services like independent laboratory, home health, durable medical equipment, etc.). Annualized population averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Ambulatory visits | 8.77 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Office visits | 3.92 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Outpatient visits | 4.85 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Emergency room visits | 0.65 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Inpatient visits | 0.39 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization | Other medical visits | 4.28 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Inpatient visits | 0.44 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Ambulatory visits | 9.56 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Emergency room visits | 0.65 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Office visits | 4.07 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Other medical visits | 4.87 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization | Outpatient visits | 5.51 visits/year |
Comparison: Ambulatory visitsp-value: 0.022Weighted clustered linear regression
Comparison: Office visitsp-value: 0.124Weighted clustered linear regression
Comparison: Outpatient visitsp-value: 0.043Weighted clustered linear regression
Comparison: Emergency room visitsp-value: 0.99Weighted clustered linear regression
Comparison: Inpatient visitsp-value: 0.039Weighted clustered linear regression
Comparison: Other medical visitsp-value: <0.001Weighted clustered linear regression
Primary
COPD-related Health Care Resource Utilization: Inpatient Days
Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization: Inpatient days. Population annualized averages of inpatient days is reported. Annualized population averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization: Inpatient Days | 3.91 inpatient days/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization: Inpatient Days | 4.42 inpatient days/year |
p-value: 0.163Weighted clustered linear regression
Primary
COPD-related Health Care Resource Utilization: Pharmacy Fills
Chronic Obstructive Pulmonary Disease (COPD)-related (medical claims with a diagnosis for COPD in any position and pharmacy claims for a COPD-related treatment, including COPD-guideline recommended antibiotics) health care resource utilization. Population annualized averages for pharmacy fills is reported. Annualized population averages of pharmacy fills were calculated as: (\[sum of all pharmacy fills for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | COPD-related Health Care Resource Utilization: Pharmacy Fills | 15.48 pharmacy fills/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | COPD-related Health Care Resource Utilization: Pharmacy Fills | 15.08 pharmacy fills/year |
p-value: 0.037Weighted clustered linear regression
Primary
Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts)
These costs were calculated for medical claims with a diagnosis for pneumonia in any position. Annualized population averages of pneumonia-related health care costs for the categories below is reported: * Medical costs (includes physician office costs, hospital outpatient costs, emergency services costs, inpatient costs, and other costs) * Ambulatory * Office visits * Outpatient visits * Emergency room visits * Inpatient stay * Other medical costs * Pharmacy costs * Total (medical + pharmacy) costs. Annualized population averages=(\[sum of all costs for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]). Costs were adjusted to 2020 dollars using the most recent year of the medical care component of the Consumer Price Index (CPI) to reflect inflation between the claim date and 2020.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 2857.23 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 80.62 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 15.03 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 65.59 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 48.91 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 2714.94 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 12.77 dollars/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 2857.23 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Total (medical + pharmacy) costs | 3466.72 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Medical costs | 3466.72 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Emergency room visits costs | 51.33 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Ambulatory costs | 98.19 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Other medical costs | 19.56 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Office visits costs | 18.03 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Inpatient stay costs | 3297.65 dollars/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) | Outpatient visits costs | 80.16 dollars/year |
Comparison: Medical costsp-value: 0.189Weighted clustered linear regression
Comparison: Ambulatory costsp-value: 0.314Weighted clustered linear regression
Comparison: Office visits costsp-value: 0.203Weighted clustered linear regression
Comparison: Outpatient visits costsp-value: 0.379Weighted clustered linear regression
Comparison: Emergency room visits costsp-value: 0.815Weighted clustered linear regression
Comparison: Inpatient stay costsp-value: 0.205Weighted clustered linear regression
Comparison: Other medical costsp-value: 0.556Weighted clustered linear regression
Comparison: Total (medical + pharmacy) costsp-value: 0.189Weighted clustered linear regression
Primary
Pneumonia-related Health Care Resource Utilization
Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of visits in each of the following categories is reported: * Ambulatory visits * Office visits * Outpatient visits * Emergency room visits * Inpatient visits * Other medical visits (independent laboratory, home health, durable medical equipment, etc.) Population annualized averages of visits were calculated as: (\[sum of all visits for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Ambulatory visits | 0.49 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Office visits | 0.13 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Outpatient visits | 0.36 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Emergency room visits | 0.10 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Inpatient visits | 0.12 visits/year |
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization | Other medical visits | 0.12 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Inpatient visits | 0.15 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Ambulatory visits | 0.66 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Emergency room visits | 0.11 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Office visits | 0.15 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Other medical visits | 0.12 visits/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization | Outpatient visits | 0.50 visits/year |
Comparison: Ambulatory visitsp-value: 0.065Weighted clustered linear regression
Comparison: Office visitsp-value: 0.102Weighted clustered linear regression
Comparison: Outpatient visitsp-value: 0.1Weighted clustered linear regression
Comparison: Emergency room visitsp-value: 0.189Weighted clustered linear regression
Comparison: Inpatient visitsp-value: 0.024Weighted clustered linear regression
Comparison: Other medical visitsp-value: 0.767Weighted clustered linear regression
Primary
Pneumonia-related Health Care Resource Utilization: Inpatient Days
Pneumonia-related health care resource utilization: This utilization was calculated for medical claims with a diagnosis for pneumonia in any position. Population annualized averages of inpatient days is reported. Population annualized averages of inpatient days were calculated as: (\[sum of all inpatient days for all individuals during the follow-up period\] / \[sum of follow-up on-treatment time in years (365 days) for all individuals\]).
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Pneumonia-related Health Care Resource Utilization: Inpatient Days | 1.72 inpatient days/year |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Pneumonia-related Health Care Resource Utilization: Inpatient Days | 1.98 inpatient days/year |
p-value: 0.357Weighted clustered linear regression
Secondary
Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization
Percentage of patients with 30-day all-cause readmission after Chronic Obstructive Pulmonary Disease (COPD) hospitalization is reported. Hospitalizations were classified as COPD-related if they met either of the following 2 criteria: * ≥1 diagnosis of COPD in the primary position any time during the acute inpatient stay; or * ≥1 diagnosis of acute respiratory failure in the primary position and a diagnosis of acute exacerbation of COPD in a later position on the same claim during an acute inpatient stay.
Time frame: Follow-up period (started on the day after the index date, with a minimum of 30-days duration (index date + 1 through index date+30) up to a maximum of 12 months duration (index date + 1 through index date +365).
Population: Patients in the Matched Overall Population with a COPD hospitalization during the follow-up period. Matched Overall Population: Stratified propensity score matching (PSM), using an exact match on some variables and a propensity score match on the others, was used to control for possible confounding of the association between the outcomes and treatment with TIO/OLO or FF/UMEC/VI. Patients were matched in a 1:1 ratio of TIO/OLO to FF/UMEC/VI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Bromide/Olodaterol (TIO/OLO) | Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization | 12.04 percentage of patients |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) | Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization | 18.25 percentage of patients |
p-value: 0.06Rao-Scott test