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Respiratory Medicine

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Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease: Novel and conventional responder analyses - 04/11/16

Doi : 10.1016/j.rmed.2016.10.002 
Donald P. Tashkin a, ⁎ , Eric D. Bateman b , Paul Jones c , Valentina B. Zubek d , Norbert Metzdorf e , Dacheng Liu d , Thomas Leonard d , Emmanuelle Clerisme-Beaty d , Robert A. Wise f
a David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA 
b Division of Pulmonology, Department of Medicine, University of Cape Town, George Street, Mowbray 7700, Cape Town, South Africa 
c St George's, University of London, Cranmer Terrace, London SW17 0RE, UK 
d Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA 
e Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany 
f Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA 

∗Corresponding author. David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, Los Angeles, CA 90095, USA. Tel. : +1 310 825 3163, +1 310 825 3163; fax: +1 310 206 5088.David Geffen School of Medicine at UCLA10833 Le Conte AvenueLos AngelesCA90095USA

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.

Le texte complet de cet article est disponible en PDF.

Highlights

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Novel SGRQ response analyses assessed HRQoL in COPD (tiotropium vs placebo).
•
SGRQ total scores were consistently better for patients on tiotropium vs placebo.
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SGRQ score net benefit was better for tiotropium vs placebo at 6 months and 1 year.
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Tiotropium maintenance therapy vs placebo had long-term sustained benefit on HRQoL.
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These data may be a benchmark to assess benefits on HRQoL of other COPD therapies.

Le texte complet de cet article est disponible en PDF.

Keywords : Chronic obstructive pulmonary disease (COPD), Clinical trials, Health-related quality of life, Responder and deteriorator rates, St George's Respiratory Questionnaire (SGRQ), Tiotropium

Abbreviations : COPD, EXACTT, FEV1, FVC, HRQoL, ICS, LABA, LAMA, MCID, MMRM, SAFE, SGRQ, TIPHON, UPLIFT


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© 2016  The Authors. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 120

P. 91-100 - novembre 2016 Retour au numéro
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