SESSION TITLE: New treatments for COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: Roflumilast was approved in the United States as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD in February 2011. This study examined the exacerbation occurrences between COPD patients treated with roflumilast and those with other maintenance drugs in real-world settings.
METHODS: This database analysis (PharMetrics Plus Database) included patients with primary ICD-9 diagnoses of COPD and using roflumilast (roflumilast group) or any other ≥3 COPD maintenance drugs (non-roflumilast group) between May 1, 2011 and December 31, 2012. The first prescription day of roflumilast or the corresponding third COPD agent was served as the index date. Patients must be enrolled for 12 months prior to (baseline period) and 3 months after (follow-up period) the index date, ≥40 years old, not corticosteroid-dependent, and without asthma diagnosis at baseline. Descriptive and difference-in-difference multivariable analyses with change-from-baseline in monthly exacerbations as the outcome were conducted.
RESULTS: A total of 15,586 patients (783 roflumilast/14,803 non-roflumilast, 52% male, mean age 63.3 years) were included. Baseline differences between roflumilast and non-roflumilast groups were found in monthly number of severe/moderate exacerbations (0.113±0.132 vs. 0.055±0.092, p<0.001), and number of COPD drugs (3.4±2.2 vs. 2.5±2.1, p<0.001). During the follow-up period, number of monthly severe/moderate exacerbations decreased by 0.0103 (9% reduction) in roflumilast group vs. increased by 0.0092 (17% increase) in non-roflumilast group (a 26% difference). More roflumilast patients had a reduction in exacerbations versus non-roflumilast patients (46% vs. 32%, p<0.001). Among these patients, roflumilast patients had greater reduction in the frequency of monthly exacerbations (0.158±0.112 vs. 0.125±0.077, p<0.001). After controlling for key baseline factors, roflumilast patients had greater reduction in monthly exacerbations (β= -0.013, SE=0.0063, p=0.04) than non-roflumilast patients.
CONCLUSIONS: This real-world study demonstrated that COPD patients treated with roflumilast had greater reduction in both incidence and frequency of severe/moderate exacerbation than those treated with other COPD maintenance medications.
CLINICAL IMPLICATIONS: Roflumilast appears to be an effective intervention aiming to reduce COPD exacerbation occurrences in the real world.
DISCLOSURE: Yin Wan: Other: Research fund from Forest Research Institute Andrew Shorr: Other: Consultant for Forest Research Institute Shawn Sun: Employee: Employee of Forest Research Institute Shelby Corman: Other: Research fund from Forest Research Institute Xingyue Huang: Employee: Employee of Forest Research Institute Xin Gao: Other: Research fund from Forest Research Institute
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