SESSION TYPE: COPD: Outcomes
PRESENTED ON: Wednesday, October 24, 2012 at 02:45 PM - 04:15 PM
PURPOSE: To evaluate whether rescue medication use is associated with near-term risk of an acute exacerbation of COPD (AECOPD).
METHODS: Generalized estimating equations were applied to assess relationship between rescue medication use and the subsequent risk of AECOPD among patients with moderate to severe COPD. The data were based on diaries for patients who received placebo (n=2,020; 74% men; mean age 63.6, SD=8.7) in 8 randomized controlled trials of indacaterol clinical trial program, including 4 three-month studies, 2 six-month studies, and 2 twelve-month studies. The models assessed whether rescue medication used over one week, measured as the mean number of puffs per day (mean=2.81; SD=3.6), influenced the odds of an AECOPD in the subsequent week. Models with and without covariates were implemented. Additional covariates selected based on clinical relevance included AECOPD occurrence in the previous year (5.4%); baseline trough FEV1 (mean=1.32L; SD=0.47); percent baseline days of poor control (mean=39.3%); current smoking status (42.5%); inhaled corticosteroid use at baseline (42.7%); and reversibility after salbutamol/albuterol (42.7%).
RESULTS: Results suggest that mean puff of rescue medication in the preceding week is associated with AECOPD in the subsequent week (OR=1.09; 95% CI: 1.07-1.11, for univariate model). This translates into a 9% increase of odds of an AECOPD in the subsequent week with one puff/day increase of rescue medication in the preceding week, and 30% increase of odds of an AECOPD in the subsequent week with 3 puff/day increase of rescue medication in the preceding week. When covariates are included, the OR estimates range from 1.07 to 1.09 and remain statistically significant at the 5% level. Results were similar when rescue medication over the prior two weeks was considered.
CONCLUSIONS: Retrospective analysis of rescue medication use in a clinical trial database suggests an association with near-term risk of exacerbations among patients with moderate to severe COPD.
CLINICAL IMPLICATIONS: The relevance of monitoring rescue medication use as a signal of near-term risk of an AECOPD should be prospectively evaluated.
DISCLOSURE: MeiLan Han: Consultant fee, speaker bureau, advisory committee, etc.: Consultant fee from Novartis
Maria Cecilia Vieira: Grant monies (from industry related sources): Research fund from Novartis
Shannon Cope: Grant monies (from industry related sources): Research grant from Novartis
Jeroen Jansen: Grant monies (from industry related sources): Research fund from Novartis
Mike Baldwin: Employee: Novartis Employee
Jie Zhang: Employee: Novartis
No Product/Research Disclosure InformationUniversity of Michigan Health System, Ann Arbor, MI