Tiotropium in chronic obstructive pulmonary disease: Gender differences in outcomes

Introduction: Chronic obstructive pulmonary disease (COPD) may impact men and women differently. Aims and objectives: To investigate differences in outcomes by gender in patients with COPD. Methods: TIOtropium Safety and Performance In Respimat ® (TIOSPIR ® ) was a randomized trial comparing tiotropium Respimat ® 5 or 2.5 µg with tiotropium HandiHaler ® 18 µg. Based on the similar efficacy and safety results in the primary analysis, treatment arms were pooled and differences in baseline characteristics and outcomes by gender were determined. Results: Of 17,116 patients from TIOSPIR ® , 72% were men and 29% women. At baseline, men had a longer smoking history (46 versus 39 pack-years) but fewer were current smokers (36% versus 44%), more severe disease (GOLD Stage III/IV, 53% versus 44%), more cardiac history (28% versus 21%) (all P P P =0.041) and death (0.73 [0.64, 0.83]) were lower than in men, including lower risks of major adverse cardiac events (MACE) (0.75 [0.62, 0.90]) and fatal MACE (0.55 [0.41, 0.72]). When patients from Asia were excluded, women had a similar risk of severe exacerbation compared with men but were at higher risk of any exacerbation and lower risk of dying. Conclusions: In TIOSPIR ® , female patients with COPD were more likely to exacerbate than men but were less likely to die. This could be partly explained by their less advanced disease and lower concomitant cardiac disease at baseline.