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Abstract: Poster Presentations |

EFFECT OF PATIENT SEX ON FORCED EXPIRATORY VOLUME IN 1 SECOND IN PATIENTS WITH MODERATE TO VERY SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE RECEIVING BUDESONIDE/FORMOTEROL PRESSURIZED METERED-DOSE INHALER FREE TO VIEW

Sheila Weaver, DO*; Stephen I. Rennard, MD; Donald P. Tashkin, MD; Jennifer McElhattan, MS; Ubaldo J. Martin, MD
Author and Funding Information

Temple University, Philadelphia, PA


Chest


Chest. 2009;136(4_MeetingAbstracts):94S. doi:10.1378/chest.136.4_MeetingAbstracts.94S-b
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Abstract

PURPOSE:  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.

METHODS:  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.

RESULTS:  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.

CONCLUSION:  Both sexes showed substantial improvements in predose and postdose FEV1 with budesonide/formoterol pMDI, with women experiencing greater percentage improvements from baseline than men.

CLINICAL IMPLICATIONS:  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.

DISCLOSURE:  Sheila Weaver, Grant monies (from industry related sources) Studies funded by AstraZeneca; No Product/Research Disclosure Information

Wednesday, November 4, 2009

12:45 PM - 2:00 PM


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