Response to Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) by Body Mass Index (BMI) and Patient's Sex in Patients With Asthm

Abstract

PURPOSE: Obesity has been associated with reduced pulmonary function in asthma. The response to BUD/FM pMDI by BMI (nonobese: <30 vs obese: ≥30 kg/m2) and patient’s sex was assessed in moderate to severe persistent asthma patients.METHODS: Data are pooled from 2 double-blind, 12-week, randomized studies (I [n=233]: NCT00652002; Drugs. 2006;66:2235; II [n=310]: NCT00702325) of asthma patients taking twice-daily BUD/FM pMDI 320/9 μg or BUD (I: pMDI 320 μg; II: dry powder inhaler 360 μg).RESULTS: Absolute improvements in pulmonary function with BUD/FM were greater in obese versus nonobese males (predose FEV1: 0.39 vs 0.23L; morning PEF 52.7 vs 31.4L/min; evening PEF: 47.5 vs 28.4L/min) and similar in obese versus nonobese females (predose FEV1: 0.14 vs 0.18L; morning PEF 26.2 vs 23.6L/min; evening PEF: 23.4 vs 21.5L/min). Improvements in pulmonary function with BUD were similar or greater in nonobese versus obese males (predose FEV1: 0.10 vs 0.01L; morning PEF 11.7 vs 3.0L/min; evening PEF: 5.4 vs 2.7L/min) and nonobese versus obese females (predose FEV1: 0.12 vs 0.09L; morning PEF 10.8 vs 3.3L/min; evening PEF: 9.4 vs 7.0L/min). Absolute mean baseline predose FEV1 was lower in females versus males in both nonobese (1.98 vs 2.59L) and obese patients (1.79 vs 2.60L). Increases in the percentage of asthma control days with BUD/FM were greater in obese versus nonobese males (22.8% vs 13.8%) and obese versus nonobese females (23.3% vs 18.6%); increases with BUD were greater in obese versus nonobese males (12.4% vs 7.9%) and similar in obese versus nonobese females (12.5% vs 11.6%).CONCLUSIONS: Obese and nonobese males and females showed improvements in pulmonary function and asthma control days with BUD/FM pMDI. Compared with nonobese patients, obese patients did not consistently show worse responses to BUD/FM or BUD treatment. Improvements in pulmonary function and asthma control days in both sexes were greater with BUD/FM versus BUD in obese and nonobese patients.CLINICAL IMPLICATIONS: These findings support the efficacy of BUD/FM pMDI 320/9 μg in obese and nonobese males and females.DISCLOSURE: Randall Brown: Consultant fee, speaker bureau, advisory committee, etc.: Merck & Company, Inc., Teva Pharmaceuticals, Ltd., Grant monies (from industry related sources): AstraZeneca LPTom Uryniak: Shareholder: AstraZeneca LP, Employee: AstraZeneca LPAjay Aggarwal: Employee: AstraZeneca LPUbaldo Martin: Shareholder: AstraZeneca LP, Employee: AstraZeneca LPNo Product/Research Disclosure Information