Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease: Novel and conventional responder analyses.
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.



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.



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.



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.
David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA. Electronic address: dtashkin@mednet.ucla.edu.
Donald P
DP
Tashkin
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.
Eric D
ED
Bateman
St George's, University of London, Cranmer Terrace, London SW17 0RE, UK. Electronic address: pjones@sgul.ac.uk.
Paul
P
Jones
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: valentina.zubek@boehringer-ingelheim.com.
Valentina B
VB
Zubek
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. Electronic address: norbert.metzdorf@boehringer-ingelheim.com.
Norbert
N
Metzdorf
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: dacheng.liu@boehringer-ingelheim.com.
Dacheng
D
Liu
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: thomas.leonard@boehringer-ingelheim.com.
Thomas
T
Leonard
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. Electronic address: emmanuelle.clerisme-beaty@boehringer-ingelheim.com.
Emmanuelle
E
Clerisme-Beaty
Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA. Electronic address: rwise@jhmi.edu.
Robert A
RA
Wise
D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001993:Bronchodilator Agents / Q000627:therapeutic use; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000494:pharmacology; D009330:Nebulizers and Vaporizers / Q000592:standards; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D012129:Respiratory Function Tests / Q000379:methods; D012720:Severity of Illness Index; D012907:Smoking / Q000453:epidemiology; D000069447:Tiotropium Bromide / Q000008:administration & dosage* / Q000494:pharmacology; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists; D000069447:Tiotropium Bromide
Chronic obstructive pulmonary disease (COPD); Clinical trials; Health-related quality of life; Responder and deteriorator rates; St George's Respiratory Questionnaire (SGRQ); Tiotropium