2011 OPEN FORUM Abstracts
EFFECT OF ROFLUMILAST TREATMENT ON HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Stephen I. Rennard1, Peter M. Calverley2, Shawn X. Sun3, Stavros Tourkodimitris3, Paul Rowe3, Dana Creanga3, Udo M. Goehring4, Dirk Bredenbroeker4, Peter Teichmann4, Manja Brose4, Donald Yin3; 1Pulmonary and Critical Care Medicine, Omaha, NE; 2The University of Liverpool, Liverpool, United Kingdom; 3Forest Research Institute, Jersey City, NJ; 4Nycomed GmbH, Konstanz, Germany
Background: Roflumilast, a once-daily oral phosphodiesterase-4 selective inhibitor recently approved by the FDA, has been shown to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The purpose of this study was to investigate the effect of roflumilast treatment on health-related quality of life (HRQoL) in COPD patients, particularly COPD patients with a history of exacerbations. Method: Data was from Study M2-111 (OPUS) - a 52 week randomized, double-blind, placebo-controlled, parallel group phase 3 clinical trial of roflumilast 500 mcg once daily in patients with COPD. The St George's Respiratory Questionnaire (SGRQ) was used to measure HRQoL. For SGRQ, a change of 4 units was generally accepted as a minimal clinically important difference. A post-hoc analysis was performed on the overall patient population, subpopulation with a history of exacerbations and subpopulation with chronic bronchitis. In each treatment group, the number and proportion of patients who improved >/= 4 units on the SGRQ total score at week 52 (last observation carried forward) were calculated and compared using chi-square test. Results: A total of 1,173 COPD patients were enrolled in the trial: 567 in the roflumilast group and 606 in the placebo group. The proportion of patients with improvements in SGRQ total score of >/= 4 units was higher in the roflumilast group than in the placebo group in the overall population (36.45% vs. 33.33%, p = 0.2875) and subpopulation with chronic bronchitis (36.72% vs. 34.02%, p = 0.4630), though these differences did not achieve statistical significance. In the subgroup of patients with a history of exacerbations (821 patients: 389 in the roflumilast group and 432 in the placebo group), the proportion of patients with >/= 4 unit improvement in SGRQ total score was 38.56% in the roflumilast group and 31.71% in the placebo group (p = 0.0399), indicating a relative improvement of 21.60% for patients in the roflumilast group. Conclusions: Analysis of this clinical trial data suggests that roflumilast provides a clinically meaningful and statistically significant improvement in HRQoL in COPD patients with a history of exacerbations. Sponsored Research - This research was funded by Forest Research Institute, Jersey City, NJ