Donald P Tashkin1, Eric D Bateman2, Paul Jones3, Valentina B Zubek4, Norbert Metzdorf5, Dacheng Liu6, Thomas Leonard7, Emmanuelle Clerisme-Beaty8, Robert A Wise9. 1. David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA. Electronic address: dtashkin@mednet.ucla.edu. 2. Division of Pulmonology, Department of Medicine, University of Cape Town, George Street, Mowbray 7700, Cape Town, South Africa. Electronic address: eric.bateman@uct.ac.za. 3. St George's, University of London, Cranmer Terrace, London SW17 0RE, UK. Electronic address: pjones@sgul.ac.uk. 4. Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: valentina.zubek@boehringer-ingelheim.com. 5. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. Electronic address: norbert.metzdorf@boehringer-ingelheim.com. 6. Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: dacheng.liu@boehringer-ingelheim.com. 7. Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: thomas.leonard@boehringer-ingelheim.com. 8. Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: emmanuelle.clerisme-beaty@boehringer-ingelheim.com. 9. Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA. Electronic address: rwise@jhmi.edu.
Abstract
INTRODUCTION: Improving health-related quality of life (HRQoL) in COPD patients is an important pharmacotherapeutic objective. This study investigated the extent, consistency, and durability of tiotropium maintenance therapy impact on HRQoL in moderate-to-very severe COPD. METHODS: Patients received once-daily tiotropium 18 μg (n = 5244) or placebo (n = 4799) via HandiHaler® (10 trials), or once-daily tiotropium 5 μg (n = 2622) or placebo (n = 2618) via Respimat® inhaler (3 trials). St George's Respiratory Questionnaire (SGRQ) total scores were measured at baseline, and 6 months (13 trials) and 1 year (9 trials) from treatment start. Adjusted mean differences between treatments for change from baseline in total scores were calculated at each time-point for each trial. Responder and deteriorator rates (decrease or increase in score ≥4 units from baseline, respectively), net benefit (responder rate increase plus deteriorator rate decrease), and cumulative improvement and deterioration were determined. RESULTS: Adjusted mean total score differences between treatments for change from baseline were significant (p < 0.05) in favor of tiotropium in 10/13 trials at 6 months and in 8/9 trials at 1 year. In all trials, estimated differences in responder rates between treatments favored tiotropium (significant [p < 0.05]: 5/13 trials at 6 months; 8/9 trials at 1 year). Net benefit favored tiotropium and cumulative improvement rates were consistently greater and deterioration rates consistently lower for tiotropium versus placebo. CONCLUSIONS: Tiotropium maintenance therapy significantly and consistently improved HRQoL in moderate-to-very severe COPD patients in a durable manner. These results may provide a benchmark for assessing benefits on HRQoL of other COPD treatments.
INTRODUCTION: Improving health-related quality of life (HRQoL) in COPDpatients is an important pharmacotherapeutic objective. This study investigated the extent, consistency, and durability of tiotropium maintenance therapy impact on HRQoL in moderate-to-very severe COPD. METHODS:Patients received once-daily tiotropium 18 μg (n = 5244) or placebo (n = 4799) via HandiHaler® (10 trials), or once-daily tiotropium 5 μg (n = 2622) or placebo (n = 2618) via Respimat® inhaler (3 trials). St George's Respiratory Questionnaire (SGRQ) total scores were measured at baseline, and 6 months (13 trials) and 1 year (9 trials) from treatment start. Adjusted mean differences between treatments for change from baseline in total scores were calculated at each time-point for each trial. Responder and deteriorator rates (decrease or increase in score ≥4 units from baseline, respectively), net benefit (responder rate increase plus deteriorator rate decrease), and cumulative improvement and deterioration were determined. RESULTS: Adjusted mean total score differences between treatments for change from baseline were significant (p < 0.05) in favor of tiotropium in 10/13 trials at 6 months and in 8/9 trials at 1 year. In all trials, estimated differences in responder rates between treatments favored tiotropium (significant [p < 0.05]: 5/13 trials at 6 months; 8/9 trials at 1 year). Net benefit favored tiotropium and cumulative improvement rates were consistently greater and deterioration rates consistently lower for tiotropium versus placebo. CONCLUSIONS:Tiotropium maintenance therapy significantly and consistently improved HRQoL in moderate-to-very severe COPDpatients in a durable manner. These results may provide a benchmark for assessing benefits on HRQoL of other COPD treatments.