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Am. J. Respir. Crit. Care Med., Volume 157, Number 3, March 1998, 827-832

Safety and Efficacy of Fluticasone and Beclomethasone in Moderate to Severe Asthma

R. A. PAUWELS, J. C. YERNAULT, M. G. DEMEDTS, and P. GEUSENS

University Hospital, University of Ghent; University Hospital, ULB Free University of Brussels; University Hospital, Catholic University of Leuven; and Dr. Willems-Institute LUC-Diepenbeek, Belgium

There are still some concerns about the safety of high doses of inhaled glucocorticosteroids (ICS). We compared the safety and efficacy of fluticasone propionate (FP) and beclomethasone dipropionate (BDP) in 306 patients with moderate to severe asthma in a double-blind, multicenter, cross-over study of 12 mo duration. During the 1-mo run-in period, bronchodilators were replaced by salmeterol 50 µg twice daily, increasing morning peak expiratory flow rate (PEFR) by 28 L/min (p < 0.001) and FEV1 by 6.2% predicted (p < 0.001). At randomization the current ICS was replaced by 500 µg BDP or 250 µg FP in accordance with previously taken 500 µg BDP or 400 µg budesonide (BUD). No significant differences between the two treatments regarding morning plasma cortisol, urinary excretion of calcium and hydroxyproline, FEV1, and PEFR were observed at any time point during the study. Osteocalcin and bone mineral density (BMD) were improved over baseline in the FP group, resulting in higher serum osteocalcin levels (mean difference 0.28 ng/ml; p < 0.001) and higher BMD in the spine (1.0%; p = 0.05), femoral neck (1.6; p < 0.01), and Ward's triangle (3.6%; p = 0.01) as compared with BDP. We conclude that chronic treatment with FP, at half the dose of BDP, results in a similar antiasthma effect but a more favorable safety profile with respect to bone metabolism and mineral density.




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