An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by GlaxoSmithKline · Observational
The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics.
The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).
This was a retrospective cohort study using a large administrative database (study period: 1/1/2003 through 6/30/2009). Date of first FSC or ACs (tiotropium; ipratropium alone or in combination with albuterol) was defined as the index date. Managed care enrollees (aged >40 years) having at least one medical claim with a primary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) and a diagnosis of depression (at least one claim with depression/anxiety or at least one prescription claim for depression/anxiety) in one-year pre-index and within 60-days post-index were defined in the comorbid population. Patients were continuously eligible throughout the one-year pre and post-index periods. Negative binomial models were used to analyze number of COPD-related events [hospitalization (IP), emergency department (ED), office visits with oral steroid and/or antibiotic prescription within 5 days (OV+Rx)] and logistic regression was used to examine risk of COPD events between the two cohorts. COPD-related costs were compared between the two cohorts using - generalized linear model with log-link/gamma distribution after adjusting for baseline differences.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha: There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts
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 AC cohorts Ha: There is a difference in COPD-related costs between FSC and AC cohorts
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The study population included patients with both COPD and depression/anxiety. They were identified as follows: Patients who had at least one pharmacy claim for a maintenance medication used to treat COPD were identified. Of these, patients were considered to have comorbid depression/anxiety if they had at least one prescription claim for a medication used to treat depression/anxiety and a diagnosis code for depression/anxiety during 1 year pre-index or within 60 days after the index date.
Exclusion Criteria:
Patients aged 40 and over with COPD and comorbid depression/anxiety. Managed care enrolees (aged \>40 years) having newly initiated drug therapy with FSC or AC during the identification period (01/01/2004 to 06/30/2008) to treat COPD with a medical or pharmacy claim for depression before and 60 days post index date were the target population. The first fill date of FSC or AC was the index date.
Drug: fluticasone propionate/salmeterol xinafoate · Drug: Anticholinergics
combination fluticasone priopionate and salmeterol xinafoate 250/50mcg
Also known as: FSC, Advair (TM)
tiotropium; ipratropium alone; or ipratropium + albuterol
Also known as: tiotropium, ACs, ipratropium
Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation
The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time frame: Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)
Number of Participants With the Indicated COPD-related Exacerbations
The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Mean Annual COPD-related Costs Per Participant
Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). 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.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
Number of the Indicated COPD-related Exacerbations
The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
Time frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)
| Milestone | FSC Cohort | AC Cohort |
|---|---|---|
| Started | 1078 | 2923 |
| Completed | 1078 | 2923 |
| Not completed | 0 | 0 |
The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
| participants | FSC Cohort | AC Cohort |
|---|---|---|
| Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation | 200 | 674 |
The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
| participants | FSC Cohort | AC Cohort |
|---|---|---|
| COPD-related hospitalization | 35 | 168 |
| COPD-related ER visit | 37 | 171 |
| COPD-related physician + Rx visit | 156 | 448 |
| COPD-related hospitalization/ER visit | 63 | 307 |
Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). 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.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
| United States (US) dollars | FSC Cohort | AC Cohort |
|---|---|---|
| COPD-related total costs | 1604 ± 3187 | 1687 ± 4299 |
| COPD-related pharmacy costs | 934 ± 814 | 684 ± 724 |
| COPD-related medical costs | 670 ± 2923 | 1003 ± 4095 |
The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
| number of exacerbations | FSC Cohort | AC Cohort |
|---|---|---|
| COPD-related hospitalization | 0.04 ± 0.2 | 0.07 ± 0.3 |
| COPD-related ER visit | 0.06 ± 0.4 | 0.07 ± 0.4 |
| COPD-related physician (phy)+Rx visit | 0.19 ± 0.6 | 0.20 ± 0.6 |
| COPD-related hospitalization/ER visit | 0.09 ± 0.5 | 0.14 ± 0.5 |
| COPD-related hospitalization/ER visit/phy+Rx visit | 0.29 ± 0.8 | 0.34 ± 0.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FSC Cohort | — | — | — |
| AC Cohort | — | — | — |
| Age, Continuous(Years) | FSC Cohort | AC Cohort | Total |
|---|---|---|---|
| Mean | 57.8 ± 9.8 | 60.3 ± 10.3 | 59.6 ± 10.2 |
| Sex: Female, Male(Participants) | FSC Cohort | AC Cohort | Total |
|---|---|---|---|
| Female | 742 | 1910 | 2652 |
| Male | 336 | 1013 | 1349 |
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