2011 OPEN FORUM Abstracts
EFFECT OF ROFLUMILAST TREATMENT ON HEALTH STATUS 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 COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. This study aimed to investigate the effect of roflumilast treatment on health status in COPD patients. 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 Transition Dyspnea Index Questionnaire (TDI) was used to measure dyspnea as an impairment of patients daily living. TDI compares the health state to that measured by the BDI (Baseline Dyspnea Index) and thus by definition it relates to changes from baseline. For TDI, a score of 1 unit improvement was generally accepted as a minimal clinically important difference. An analysis was performed on the overall patient population, subpopulation with a history of exacerbations and subpopulation with chronic bronchitis. In each treatment group, the proportion of patients with improvements or deteriorations in TDI focal score of > 1 unit at week 52 (last observation carried forward) was calculated and was 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 TDI focal score of > 1 unit was higher in the roflumilast group than in the placebo group in the overall population (38.70% vs. 30.92%, p = 0.0059), subpopulation with a history of exacerbations (38.85% vs. 29.63%, p = 0.0040), and subpopulation with chronic bronchitis (41.46% vs. 33.06%, p = 0.0193). The proportion of patients with deteriorations in TDI focal score of > 1 unit was lower in the roflumilast group than in the placebo group in the overall population (16.85% vs. 25.55%, p = 0.0004), subpopulation with a history of exacerbations (15.83% vs. 26.14%, p = 0.0002), and subpopulation with chronic bronchitis (15.69% vs. 23.31%, p = 0.0097). All the differences were statistically significant. Conclusions: An analysis of clinical trial data demonstrated that roflumilast improves dyspnea outcomes in COPD patients, particularly among those with a history of exacerbations. Reducing exacerbations for COPD patients with a history of exacerbations may improve health status. Sponsored Research - This research was funded by Forest Research Institute, Jersey City, NJ