By Maggie Schwarz
WASHINGTON, DC -- March 17, 2009 -- Treatment with fixed- and adjustable-dose budesonide/formoterol or fixed-dose fluticasone propionate/salmeterol inhalers improves asthma outcome and is well tolerated regardless of racial group, researchers stated here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
Shailen R. Shah, MD, Pennsylvania Allergy & Asthma Consultants, Collegeville, Pennsylvania, led a team of investigators in evaluating the efficacy and tolerability of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients assigned to racial demographic groups of white (n = 670, n = 341, respectively), black (n = 107, n = 50), and other (n = 39, n = 15).
The average annual prevalence of asthma in the United States is approximately 9.2% in blacks and 6.9% in whites, with more blacks experiencing asthma exacerbations than whites (5.4% vs 3.9%), according to a National Health Interview Survey 2001-2003, Dr. Shah explained. Whether disparities in disease prevalence and severity in blacks and other racial demographic groups are paralleled by disparities in treatment efficacy is controversial.
Speaking here at a poster presentation on March 15, Dr. Shah's group presented the efficacy and tolerability results from a 7-month randomised, prospective, open-label study of budesonide/formoterol pressurised metered-dose inhaler and fluticasone propionate/salmeterol dry-powder inhaler in 1,222 patients with asthma.
Forced expiratory volume in 1 second (FEV1) was determined from the highest of 3 satisfactory attempts performed at visits 1 through 5. Patients kept daily paper diaries of their peak expiratory flows, asthma symptom scores, nighttime awakenings due to asthma, rescue-medication use, and days free of rescue medication.
Treatment with fixed-dose budesonide/formoterol in patients categorised as white, black, and other, respectively, demonstrated improvement in the following categories: predose FEV1 (0.15, 0.14, 0.15 L); morning peak expiratory flow (PEF) (31.38, 29.02, 35.63 L/min); nighttime symptoms (scale: 0-3) (-0.36, -0.42, -0.32); and rescue-medication use (-1.29, -1.60, -1.31 inhalations daily).
Treatment with adjustable-dose budesonide/formoterol improved predose FEV1 (0.13, 0.08, 0.18); morning PEF (35.60, 25.13, 36.95); nighttime symptoms (-0.41, -0.28, -0.43); and rescue-medication use (-1.44, -1.30, -1.46), respectively. Treatment with fixed-dose fluticasone propionate/salmeterol improved predose FEV1 (0.16, 0.15, 0.08); morning PEF (34.39, 20.30, 47.50); nighttime symptoms (-0.36, -0.40, -0.39); and rescue-medication use (-1.35, -0.95, -1.20), respectively.
The incidence of specific adverse effects varied among racial groups. Headache was the most common adverse event across groups (10.7% to 13.0%). Serious adverse events occurred in 20 (2.0%) white patients, 3 (1.9%) black patients, and 2 (3.7%) other patients.
Both budesonide/formoterol and fluticasone propionate/salmeterol improve asthma outcomes and are well tolerated, regardless of race, Dr. Shah concluded.
Funding for this study was provided by AstraZeneca Pharmaceuticals LP.
[Presentation title: Efficacy and Tolerability of Fixed-Dose (FD) and Adjustable-Dose (AD) Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) and FD Fluticasone Propionate/Salmeterol Dry Powder Inhaler (FP/SAL DPI) Within Racial Groups. Abstract 295]
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