Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial.
BACKGROUND
Gender differences may occur in many chronic diseases. We have examined the influence of gender in chronic obstructive pulmonary disease (COPD) on long-term responses to tiotropium.


METHODS
Subgroup analysis of data from the Understanding the Potential Long-term Impact of Tiotropium (UPLIFT) trial (4-year, randomized, double-blind, placebo-controlled trial of tiotropium in patients with COPD).


RESULTS
Of 5992 patients, 75% were men and 25% women. Mean age was 65 and 63 years, respectively. Baseline post-bronchodilator forced expiratory volume in 1s (FEV(1))=47% predicted(men) and 49% predicted(women). St George's Respiratory Questionnaire (SGRQ) total score was 44.9 and 48.7units, respectively. At 48 months, improvement in trough FEV(1) over control was 92mL(men) and 77mL(women) (p<0.001 for both), with no differences in the rate of decline (trial primary endpoint). Hazard ratio (HR) (95% confidence interval [CI]) for first exacerbation (tiotropium/placebo) was 0.87(0.81, 0.93)(men) and 0.83(0.74, 0.94)(women). Number of exacerbations (per patient-year) was reduced with tiotropium in men (from 0.82 to 0.71) and women (from 0.92 to 0.77) (p<0.005 for both). HR (95% CI) for a hospitalized exacerbation was 0.89(0.79, 0.99) and 0.77(0.62, 0.94), respectively. HR (95% CI) for mortality during treatment was 0.85(0.72, 0.99)(men) and 0.85(0.62, 1.18)(women). Improvements in SGRQ total score (tiotropium-control) at 1, 2, 3 and 4 years were: -2.8, -2.3, -3.6, -2.4(men) and -2.7, -2.6, -2.6, -2.1(women) (p<0.05 for all).


CONCLUSIONS
Long-term treatment of COPD with tiotropium improves lung function, exacerbations and health status in men and women, with similar magnitudes of benefit. Boehringer Ingelheim trial 205.235; ClinicalTrials.gov: NCT00144339.
Tashkin
Donald
D
Department of Medicine, David Geffen School of Medicine, UCLA, Los Angeles, CA 90095-1690, USA. dtashkin@mednet.ucla.edu
Celli
Bartolome
B
Kesten
Steven
S
Lystig
Ted
T
Decramer
Marc
M
D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D011788:Quality of Life; D012129:Respiratory Function Tests / Q000379:methods; D012602:Scopolamine Derivatives / Q000627:therapeutic use*; D012737:Sex Factors; D011795:Surveys and Questionnaires; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide