Evidence suggests that tobacco smoke more adversely affects pulmonary function in women than men (Scanlon et al. Am J Respir Crit Care Med. 2000;161:381–390) and that benefits of inhaled corticosteroid therapy for chronic obstructive pulmonary disease (COPD) are greater in women than men (Soriano et al. Chest. 2007;131:682–689). Therefore, the effect of sex on forced expiratory volume in 1 second (FEV1) in response to budesonide/formoterol pressurized metered-dose inhaler (pMDI) in patients with COPD was evaluated.
A post hoc analysis was performed on data from 2 randomized, double-blind, multicenter studies (study I: 6-month; NCT00206154 [Tashkin et al. Drugs. 2008;68:1975]; study II: 12-month; NCT00206167 [Rennard et al. Drugs. 2009;69:549) of patients ≥ 40 years with moderate to very severe COPD. Changes from baseline (last predose FEV1 before randomized treatment) to treatment average in predose and 1-hour postdose FEV1 were assessed in men and women receiving twice-daily budesonide/formoterol pMDI 320/9μg, budesonide/formoterol pMDI 160/9μg, budesonide pMDI 320μg + formoterol dry powder inhaler (DPI) 9μg (study I only), budesonide pMDI 320μg (study I only), formoterol DPI 9μg, or placebo.
Mean baseline predose FEV1 (L) values were lower in women (0.8–0.9; study I, n = 543; study II, n = 709) versus men (1.1–1.2; study I, n = 1154; study II, n = 1255). In patients receiving budesonide/formoterol 320/9μg, mean percentage improvements from baseline in predose and postdose FEV1 were greater in women (study I: 12.8 and 25.7, respectively; study II: 14.1 and 28.6) versus men (study I: 9.6 and 21.1; study II: 8.8 and 21.2). A similar trend was observed for all treatment groups. However, the sex-by-treatment interaction term based on absolute mean changes from baseline FEV1 was not significant for either variable.
Both sexes showed substantial improvements in predose and postdose FEV1 with budesonide/formoterol pMDI, with women experiencing greater percentage improvements from baseline than men.
Lower baseline FEV1 values in women versus men with moderate to very severe COPD may contribute to the greater improvement in FEV1 observed with treatment in women.
Sheila Weaver, Grant monies (from industry related sources) Studies funded by AstraZeneca; No Product/Research Disclosure Information