Gender differences may occur in many chronic diseases. We have examined the influence of gender in COPD on long-term responses to tiotropium (TIO).
Analysis of patients in the UPLIFT trial (4-yr randomised, double-blind, placebo(PBO)-controlled trial of TIO). Inclusion criteria: post-bronchodilator(BD) FEV1≤70%, age >40 yrs, >10 pk-yrs smoking. Spirometry, exacerbations, St. George's Respiratory Questionnaire and adverse events were monitored throughout the trial.
Of 5,992 patients, 75% were men and 25% women. Mean age was 65 and 63 yrs respectively. Baseline post-bronchodilator FEV1=1.41 L (47% pred)[men] and 1.07 L (49% pred)[women]. Corresponding SGRQ total score was 44.9 and 48.7 units. At 48 mths, improvement in trough FEV1 (TIO-PBO) was 92 ml (men) and 77 ml (women) (p<0.001 for both), with no differences in the rate of decline. Corresponding improvements in trough FVC were 173 and 149 ml, respectively (p<0.001 for both). The hazard ratio(HR)(95% CI) for first exacerbation(TIO/PBO) was 0.87 (0.81, 0.93) [men] and 0.83 (0.74, 0.94) [women]. The #exacerbations (per patient-year) was reduced with TIO in men (0.82 to 0.71) and women (0.92 to 0.77) (p<0.05 for both). HR (95%CI) for a hospitalized exacerbation was 0.89 (0.79, 0.99) and 0.77 (0.62, 0.94) respectively. The HR(95%CI) for mortality during treatment was 0.85 (0.72, 0.99)[men] and 0.85 (0.62, 1.18)[women]. The improvements in SGRQ total score (TIO-PBO) 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 values).
Long-term treatment with tiotropium improves lung function, exacerbations and health-related quality of life in men and women, with similar magnitudes of benefit.
Tiotropium is effective over the long-term in men and women. Supported by Boehringer-Ingelheim and Pfizer.
Donald Tashkin, No Financial Disclosure Information; No Product/Research Disclosure Information