Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).
Interventions
Tiotropium+Olodaterol
DEVICESpiolto Respimat
Spiolto Respimat Inhaler device
DRUGLong-acting muscarinic antagonists (LAMAs)
Long-acting muscarinic antagonists (LAMAs)
DRUGLong-acting β2-agonists (LABAs)
Long-acting β2-agonists (LABAs)
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
Patients treated with Tio+Olo: Inclusion criteria: 1. At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019. 2. Aged ≥ 40 years on the index date. 3. At least one diagnosis of COPD at any time prior to or on the index date. 4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. At least one record in the health insurance system database.
Exclusion criteria
1. Any use of Tio+Olo in free or fixed form within one year prior to the index date. 2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date. Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs): Inclusion criteria: 1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019. 2. Aged ≥ 40 years on the index date. 3. At least one diagnosis of COPD at any time prior to or on the index date- 4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. At least one record in the health insurance system database.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other. |
| Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | From index date between 1st January 2014 until 31st December 2019. Up to 2160 days. | Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | At index date between 2014-2019 | Number of patients by season of cohort entry date according to whether they started Tio+Olo or another LAMA/LABA. The reported seasons are: Spring (Mar-May), Summer (Jun-Aug), Fall (Sep-Nov) and Winter (Dec-Feb). |
| Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | At index date between 2014-2019 | Number of patients by Calendar year of cohort entry according to whether they started Tio+Olo or another LAMA/LABA. The reported year groups are: 2014, 2015, 2016, 2017, 2018 and 2019. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by specific previous COPD treatment during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Long-acting muscarinic antagonists (LAMA) monotherapy, Long-acting β2-agonists (LABA) monotherapy, Inhaled corticosteroids (ICS) monotherapy, ICS containing therapy and LAMA+LABA free combinations. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by use of other respiratory drugs during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Mucolytics, Theophylline, Short-acting beta-agonists and Short-acting muscarinic antagonists. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+ according to the frequency of previous acute COPD exacerbation in 1 year for each patient. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | At index date between 2014-2019. Up to 2160 days. | Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA |
| Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days. | Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days. | Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of hospitalizations caused by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of all-cause hospitalizations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of participants with comorbidities in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following comorbidities are reported: Cardiovascular disease, Cerebrovascular disease, Diabetes, Chronic kidney disease, Pneumonia, Cancer and Cirrhosis. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Charlson Comorbidity Index (CCI) according to whether they started Tio+Olo or another LAMA/LABA is reported. The CCI (using Deyo version) is a comorbidity index used to evaluate survival rate in patients with multiple comorbidities. 17 comorbidities were assessed with different weights, and the total score was determined by adding the scores of each comorbidity. The total score goes from 0 to 37, with higher values predicting a higher mortality rate. |
| Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days. | Number of participants with history of medications dispensed in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following medications are reported: Antihypertensives, Antiarrhythmics, Nitrates, Heart failure medications, Lipid-lowering medications, Blood glucose-lowering medications, Anticoagulants and antiplatelet agents, Antibiotics and Antineoplastic agents. |
| Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days. | Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+. |
| Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | At index date between 2014-2019 | Number of patients by age groups according to whether they started Tio+Olo or another LAMA/LABA. The reported age groups are: 40-59, 60-79 and 80+. |
Countries
China
Participant flow
Recruitment details
This was an observational study based on existing data from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019. This study aimed to estimate the incidence of safety outcomes in Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan who initiated Tiotropium / Olodaterol (Tio/Olo).
Pre-assignment details
Every patient who fulfilled inclusion and exclusion criteria was selected until the required sample size was achieved.
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium/Olodaterol (Tio/Olo) Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data. | 5,820 |
| Other LABA/LAMA Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data. | 13,647 |
| Total | 19,467 |
Baseline characteristics
| Characteristic | Tiotropium/Olodaterol (Tio/Olo) | Other LABA/LAMA | Total |
|---|---|---|---|
| Age, Continuous | 72 Years | 69 Years | 70 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 653 Participants | 1384 Participants | 2037 Participants |
| Sex: Female, Male Male | 5167 Participants | 12263 Participants | 17430 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 526 / 5,820 |
| other Total, other adverse events | 2,014 / 5,820 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
Population: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Arrhythmia | 6.80 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Myocardial ischemia | 4.02 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Supraventricular tachycardia | 0.33 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Glaucoma | 1.13 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal myocardial infarction (1) | 0.59 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal hemorrhagic stroke (1) | 0.18 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal ischemic stroke (1) | 1.03 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal ischemic stroke (2) | 1.67 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal, Acute, but ill-defined, cerebrovascular disease (1) | 0 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal, Acute, but ill-defined, cerebrovascular disease (2) | 0 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Death | 19.15 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal myocardial infarction (2) | 1.11 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events | Nonfatal hemorrhagic stroke (2) | 0.66 Events per 100 person-years |
Primary
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
Population: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Severe COPD exacerbation | 15.66 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Moderate COPD exacerbation | 19.71 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Constipation | 17.06 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Urinary retention | 6.17 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Urinary tract infection (1) | 2.53 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Urinary tract infection (2) | 9.44 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Urticaria | 6.96 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Urinary tract infection (3) | 13.54 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Rash | 0.69 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Nasopharyngitis | 10.63 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Pneumonia- Diagnosis codes were primary inpatient diagnosis associated with a hospitalization | 0.55 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Pneumonia-Diagnosis codes were primary or secondary diagnosis associated with a hospitalization | 0.84 Events per 100 person-years |
| Tiotropium/Olodaterol (Tio/Olo) | Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events | Diarrhoea | 1.58 Events per 100 person-years |
Secondary
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
Number of patients by age groups according to whether they started Tio+Olo or another LAMA/LABA. The reported age groups are: 40-59, 60-79 and 80+.
Time frame: At index date between 2014-2019
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 40-59 years old | 905 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 60-79 years old | 3151 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 80+ years old | 1764 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 40-59 years old | 2826 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 60-79 years old | 8080 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age | 80+ years old | 2741 Participants |
Secondary
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
Number of patients by Calendar year of cohort entry according to whether they started Tio+Olo or another LAMA/LABA. The reported year groups are: 2014, 2015, 2016, 2017, 2018 and 2019.
Time frame: At index date between 2014-2019
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2018 | 1944 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2019 | 2577 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2014 | 0 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2015 | 150 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2016 | 241 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2017 | 908 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2016 | 2477 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2018 | 3262 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2015 | 945 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2019 | 3254 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2017 | 3491 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry | 2014 | 218 Participants |
Secondary
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Number of patients by season of cohort entry date according to whether they started Tio+Olo or another LAMA/LABA. The reported seasons are: Spring (Mar-May), Summer (Jun-Aug), Fall (Sep-Nov) and Winter (Dec-Feb).
Time frame: At index date between 2014-2019
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Spring | 1535 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Summer | 1484 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Winter | 1332 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Fall | 1469 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Fall | 3273 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Spring | 3748 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Winter | 3257 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date | Summer | 3369 Participants |
Secondary
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA
Time frame: At index date between 2014-2019. Up to 2160 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | Male | 5167 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | Female | 653 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | Male | 12263 Participants |
| Other LABA/LAMA | Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex | Female | 1384 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
Number of all-cause hospitalizations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 2+ | 1104 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 0 | 3405 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 1 | 1311 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 1 | 2902 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 2+ | 1472 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date | 0 | 9273 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 0 | 4738 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 1 | 802 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 280 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 0 | 11791 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 1 | 1548 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 308 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date
Charlson Comorbidity Index (CCI) according to whether they started Tio+Olo or another LAMA/LABA is reported. The CCI (using Deyo version) is a comorbidity index used to evaluate survival rate in patients with multiple comorbidities. 17 comorbidities were assessed with different weights, and the total score was determined by adding the scores of each comorbidity. The total score goes from 0 to 37, with higher values predicting a higher mortality rate.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date | 1.33 Score on a scale | Standard Deviation 1.14 |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date | 0.97 Score on a scale | Standard Deviation 1.02 |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Number of participants with comorbidities in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following comorbidities are reported: Cardiovascular disease, Cerebrovascular disease, Diabetes, Chronic kidney disease, Pneumonia, Cancer and Cirrhosis.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Diabetes | 1217 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Pneumonia | 71 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cerebrovascular disease | 857 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cancer | 274 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Chronic kidney disease | 58 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cirrhosis. | 119 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Carrdiovascular disease | 2979 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cirrhosis. | 279 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Carrdiovascular disease | 5741 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cerebrovascular disease | 1155 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Diabetes | 2407 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Chronic kidney disease | 224 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Pneumonia | 218 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date | Cancer | 469 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Number of participants with history of medications dispensed in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following medications are reported: Antihypertensives, Antiarrhythmics, Nitrates, Heart failure medications, Lipid-lowering medications, Blood glucose-lowering medications, Anticoagulants and antiplatelet agents, Antibiotics and Antineoplastic agents.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Heart failure medications | 2004 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antineoplastic agents. | 286 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Lipid-lowering medications | 1636 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antihypertensives | 4027 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Blood glucose-lowering medications | 1386 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antibiotics | 4127 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Anticoagulants and antiplatelet agents | 2473 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antiarrhythmics | 2192 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Nitrates | 1064 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antineoplastic agents. | 502 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Nitrates | 2227 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antibiotics | 9103 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antihypertensives | 8720 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Antiarrhythmics | 2192 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Heart failure medications | 4086 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Lipid-lowering medications | 3823 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Blood glucose-lowering medications | 2785 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date | Anticoagulants and antiplatelet agents | 5073 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
Number of hospitalizations caused by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 0 | 5475 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 1 | 296 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 2+ | 49 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 0 | 13149 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 1 | 443 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date | 2+ | 55 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date
Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+ according to the frequency of previous acute COPD exacerbation in 1 year for each patient.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 1 | 483 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 0 | 5209 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 128 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 0 | 12556 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 123 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date | 1 | 968 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date
Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 0 | 5222 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 1 | 520 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 78 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 0 | 12738 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 1 | 809 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date | 2+ | 100 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
Number of patients by specific previous COPD treatment during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Long-acting muscarinic antagonists (LAMA) monotherapy, Long-acting β2-agonists (LABA) monotherapy, Inhaled corticosteroids (ICS) monotherapy, ICS containing therapy and LAMA+LABA free combinations.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Long-acting β2-agonists (LABA) monotherapy | 112 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | ICS containing therapy | 668 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Inhaled corticolsteroids (ICS) monotherapy | 76 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | LAMA+LABA free combinations | 699 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Long-acting muscarinic antagonists (LAMA) monotherapy | 75 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | LAMA+LABA free combinations | 0 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Long-acting muscarinic antagonists (LAMA) monotherapy | 465 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Long-acting β2-agonists (LABA) monotherapy | 670 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | Inhaled corticolsteroids (ICS) monotherapy | 44 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment | ICS containing therapy | 1318 Participants |
Secondary
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Number of patients by use of other respiratory drugs during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Mucolytics, Theophylline, Short-acting beta-agonists and Short-acting muscarinic antagonists.
Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Mucolytics | 4324 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Theophylline | 2468 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Short-acting beta-agonists | 1670 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Short-acting muscarinic antagonists. | 911 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Short-acting muscarinic antagonists. | 1300 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Mucolytics | 9541 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Short-acting beta-agonists | 2719 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs | Theophylline | 5913 Participants |
Secondary
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 0 | 5390 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 1 | 412 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 2+ | 18 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 0 | 12612 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 1 | 1002 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date | 2+ | 33 Participants |
Secondary
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 0 | 5628 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 1 | 192 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 2+ | 0 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 0 | 13115 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 1 | 532 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date | 2+ | 0 Participants |
Secondary
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Time frame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 0 | 5564 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 1 | 256 Participants |
| Tiotropium/Olodaterol (Tio/Olo) | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 2+ | 0 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 0 | 13111 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 1 | 536 Participants |
| Other LABA/LAMA | Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date | 2+ | 0 Participants |