To the Editor:
The paper by Mann et al (July 2003) (1) concludes that treatment with formoterol, 24 [micro]g bid, in patients with asthma may lead to more serious asthma exacerbations as compared to placebo. The authors based their conclusion on three studies in which 24 [micro]g of formoterol bid was compared with placebo, from which one study was performed in children. The number of serious exacerbations in these studies was slightly higher for formoterol but not statistically different between groups. We performed a 6-month study (2) with inhaled formoterol, 24 [micro]g bid, in 239 adult patients with moderate asthma, showing contrasting results. We found a similar incidence of exacerbations as measured by the number of prednisolone courses: 26.4% of patients receiving formoterol needed at least one prednisolone course and 28.1% receiving placebo. Moreover, the number of patients who discontinued the study because of deterioration of asthma was higher in the placebo group (n = 6) than in the formoterol group (n = 1). Our patients continued their previously prescribed inhaled corticosteroids throughout this double-blind study. The finding that formoterol reduces and not increases the number of asthma exacerbations is consistent with studies (3,4) that were designed to measure the effect of lower dosages of formoterol on exacerbations in moderate asthma. Our study showed that a higher dose of formoterol in conjunction with inhaled corticosteroids is also safe and will not lead to extra concern. Though Mann et al (1) stated that patients of the three studies presented were allowed to continue their steroids, the article did not reveal whether the patients with the reported serious exacerbations received inhaled corticosteroids. This might be a more important explanation for the number of serious exacerbations than the difference in formoterol dosage between the studies cited by Mann et all and other studies.
Thys van der Molen, MD
University of Groningen
Groningen, the Netherlands
REFERENCES
(1) Mann M, Chowdhury B, Sullivan E, et al. Serious asthma exacerbations in asthmatics treated with high-dose formoterol. Chest 2003; 124:70-74
(2) Van der Molen T, Postma DS, Turner MO, et al. Effects of the long acting [beta] agonist formoterol on asthma control in asthmatic patients using inhaled corticosteroids. Thorax 1997; 52:525-539
(3) Pauwels RA, Lofdahl C-G, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Eng J Med 1997; 337:1405-1411
(4) O'Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial. Am J Respir Crit Care Med 2001; 164:1392-1397
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: permissions@chestnet.org).
Correspondence to: Thys van der Molen, MD, Department of General Practice, University of Groningen, Bloemsingel 1, Groningen 9713 BZ, the Netherlands; e-mail: t.van.der.molen@med. rug.nl
COPYRIGHT 2004 American College of Chest Physicians
COPYRIGHT 2004 Gale Group
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