Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone propionate/salmeterol xinafoate (Drug); Anticholinergics (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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).
Clinical Details
Official title: Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a Comorbid COPD-Depression/Anxiety Population
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation
Secondary outcome: Number of Participants With the Indicated COPD-related ExacerbationsMean Annual COPD-related Costs Per Participant Number of the Indicated COPD-related Exacerbations
Detailed description:
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
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of COPD in any field in the pre-index period and 60 days after the index
date
- Diagnosis of depression/anxiety in any field and a medication for treating
depression/anxiety in the pre-index period and 60 days after the index date
- Index date occurs during identification period
- Patients must be continuously eligible during 1-year pre and 1-year post-index date
and be of at least 40 years of age
Exclusion Criteria:
- comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to
tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary
tuberculosis, sarcoidosis) during the 1 year pre or post-index periods
- No other maintenance medications other than the index medication on or 60 days after
the index date
Locations and Contacts
Additional Information
Starting date: October 2010
Last updated: June 16, 2011
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