TY - JOUR
T1 - Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease
T2 - Novel and conventional responder analyses
AU - Tashkin, Donald P.
AU - Bateman, Eric D.
AU - Jones, Paul
AU - Zubek, Valentina B.
AU - Metzdorf, Norbert
AU - Liu, Dacheng
AU - Leonard, Thomas
AU - Clerisme-Beaty, Emmanuelle
AU - Wise, Robert A.
N1 - Funding Information:
The original trials were supported by Boehringer Ingelheim and Pfizer Inc. The current post-hoc analysis was supported by BIPI, which is represented by Valentina B. Zubek, Norbert Metzdorf, Dacheng Liu, Thomas Leonard, and Emmanuelle Clerisme-Beaty as authors of the present paper. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Funding Information:
Writing, editorial support, and formatting assistance was provided by Jane M. Gilbert BSc CMPP of Envision Scientific Solutions, which was contracted and funded by BIPI for these services.
Funding Information:
Robert A. Wise reports grants and personal fees from Boehringer Ingelheim during the conduct of the study. He reports personal fees AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, ContraFect, GlaxoSmithKline, Janssen, Mylan, Novartis, Pfizer, Pulmonx, Roche, Spiration, Sunovion, Teva, Theravance, Verona, and Vertex, and grants from Boehringer Ingelheim, GlaxoSmithKline, and Pearl Therapeutics outside the submitted work.
Publisher Copyright:
© 2016
PY - 2016/11/1
Y1 - 2016/11/1
N2 - 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.
AB - 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.
KW - Chronic obstructive pulmonary disease (COPD)
KW - Clinical trials
KW - Health-related quality of life
KW - Responder and deteriorator rates
KW - St George's Respiratory Questionnaire (SGRQ)
KW - Tiotropium
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U2 - 10.1016/j.rmed.2016.10.002
DO - 10.1016/j.rmed.2016.10.002
M3 - Article
C2 - 27817821
AN - SCOPUS:84991726466
SN - 0954-6111
VL - 120
SP - 91
EP - 100
JO - Respiratory Medicine
JF - Respiratory Medicine
ER -