Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \>60-day gap between medication fills; or end of study period. This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below. Specifically the study hypotheses for the primary outcome being tested were: Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT
Interventions
Patients filling a prescription for fluticasone/salmeterol combination as index drug
OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists
Sponsors
Study design
Eligibility
Inclusion criteria
* At least one hospitalization with a primary or secondary diagnosis of COPD or at least one ER visit with a primary diagnosis of COPD * Initiatiation (prescription) of FSC or non-FSC (i.e. TIO, ICS, LABA, IPR) during peri-index period * At least 40 years of age * Continuous eligibility in the pre-index, peri-index, and follow-up periods
Exclusion criteria
* Presence of exclusionary comorbid conditions during pre-index, peri-index, and follow-up periods: respiratory cancer, cystic fibrosis, fibrosis due to TB, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis * Controller medication use during peri-index period * COPD-related hospitalization, ER visit, or physician visit plus OCS/Abx within 3 days of visit during the peri-index period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) | The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) | The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types. |
| Mean Monthly COPD-related Costs Per Participant | Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008) | Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD. |
Participant flow
Recruitment details
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone/Salmeterol Combination (FSC) Cohort Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day | 1,291 |
| Other Maintenance Therapies Cohort Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available. | 4,386 |
| Total | 5,677 |
Baseline characteristics
| Characteristic | Fluticasone/Salmeterol Combination (FSC) Cohort | Other Maintenance Therapies Cohort | Total |
|---|---|---|---|
| Age, Continuous | 67.1 Years STANDARD_DEVIATION 12.1 | 68.5 Years STANDARD_DEVIATION 12.1 | 68.2 Years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 698 Participants | 2183 Participants | 2881 Participants |
| Sex: Female, Male Male | 593 Participants | 2203 Participants | 2796 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.
Time frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluticasone/Salmeterol Combination (FSC) Cohort | Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | 8.6 participants per 100 person-years |
| Other Maintenance Therapies Cohort | Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | 16.3 participants per 100 person-years |
Mean Monthly COPD-related Costs Per Participant
Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.
Time frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone/Salmeterol Combination (FSC) Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related total costs | 205 United States (US) dollars | Standard Deviation 459.4 |
| Fluticasone/Salmeterol Combination (FSC) Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related pharmacy costs | 121 United States (US) dollars | Standard Deviation 121.8 |
| Fluticasone/Salmeterol Combination (FSC) Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related medical costs | 84 United States (US) dollars | Standard Deviation 432.5 |
| Other Maintenance Therapies Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related total costs | 297 United States (US) dollars | Standard Deviation 1376.4 |
| Other Maintenance Therapies Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related pharmacy costs | 126 United States (US) dollars | Standard Deviation 307.7 |
| Other Maintenance Therapies Cohort | Mean Monthly COPD-related Costs Per Participant | COPD-related medical costs | 171 United States (US) dollars | Standard Deviation 1331.4 |
Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years
The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.
Time frame: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
Population: Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone/Salmeterol Combination (FSC) Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related hospitalization | 2.8 participants per 100 person-years |
| Fluticasone/Salmeterol Combination (FSC) Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related ER visit | 6.6 participants per 100 person-years |
| Fluticasone/Salmeterol Combination (FSC) Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related physician + Rx visit | 27.2 participants per 100 person-years |
| Fluticasone/Salmeterol Combination (FSC) Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related hospitalization/ER visit/physician+Rx | 34.6 participants per 100 person-years |
| Other Maintenance Therapies Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related hospitalization/ER visit/physician+Rx | 50.7 participants per 100 person-years |
| Other Maintenance Therapies Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related hospitalization | 6.0 participants per 100 person-years |
| Other Maintenance Therapies Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related physician + Rx visit | 37.4 participants per 100 person-years |
| Other Maintenance Therapies Cohort | Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years | COPD-related ER visit | 12.0 participants per 100 person-years |