Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease

Novel and conventional responder analyses

Donald P. Tashkin, Eric D. Bateman, Paul Jones, Valentina B. Zubek, Norbert Metzdorf, Dacheng Liu, Thomas Leonard, Emmanuelle Clerisme-Beaty, Robert A Wise

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)91-100
Number of pages10
JournalRespiratory Medicine
Volume120
DOIs
StatePublished - Nov 1 2016

Fingerprint

Chronic Obstructive Pulmonary Disease
Quality of Life
Placebos
Therapeutics
Benchmarking
Tiotropium Bromide
Nebulizers and Vaporizers

Keywords

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

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease : Novel and conventional responder analyses. / Tashkin, Donald P.; Bateman, Eric D.; Jones, Paul; Zubek, Valentina B.; Metzdorf, Norbert; Liu, Dacheng; Leonard, Thomas; Clerisme-Beaty, Emmanuelle; Wise, Robert A.

In: Respiratory Medicine, Vol. 120, 01.11.2016, p. 91-100.

Research output: Contribution to journalArticle

Tashkin, Donald P. ; Bateman, Eric D. ; Jones, Paul ; Zubek, Valentina B. ; Metzdorf, Norbert ; Liu, Dacheng ; Leonard, Thomas ; Clerisme-Beaty, Emmanuelle ; Wise, Robert A. / Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease : Novel and conventional responder analyses. In: Respiratory Medicine. 2016 ; Vol. 120. pp. 91-100.
@article{6adea05b09ad40d6bab5d768d35c3b5b,
title = "Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease: Novel and conventional responder analyses",
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{\circledR} (10 trials), or once-daily tiotropium 5 μg (n = 2622) or placebo (n = 2618) via Respimat{\circledR} 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.",
keywords = "Chronic obstructive pulmonary disease (COPD), Clinical trials, Health-related quality of life, Responder and deteriorator rates, St George's Respiratory Questionnaire (SGRQ), Tiotropium",
author = "Tashkin, {Donald P.} and Bateman, {Eric D.} and Paul Jones and Zubek, {Valentina B.} and Norbert Metzdorf and Dacheng Liu and Thomas Leonard and Emmanuelle Clerisme-Beaty and Wise, {Robert A}",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.rmed.2016.10.002",
language = "English (US)",
volume = "120",
pages = "91--100",
journal = "Respiratory Medicine",
issn = "0954-6111",
publisher = "W.B. Saunders Ltd",

}

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

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

UR - http://www.scopus.com/inward/record.url?scp=84991726466&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84991726466&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2016.10.002

DO - 10.1016/j.rmed.2016.10.002

M3 - Article

VL - 120

SP - 91

EP - 100

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

ER -