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Communications to the Editor |

Salmeterol Powder Provides Significantly Better Benefit Than Montelukast in Asthmatic Patients Receiving Concomitant Inhaled Corticosteroid Therapy FREE TO VIEW

J. Christian Virchow, MD, FCCP
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University Medical Clinic Freiburg, Germany

Correspondence to: J. Christian Virchow, MD, FCCP, Dept. of Pneumology, Ernst-Heydemann-Str. 6, D-18055 Rostock, Germany; e-mail: johann-christian.virchow@med.uni-rostock



Chest. 2002;121(6):2083-2084. doi:10.1378/chest.121.6.2083-a
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To the Editor:

I have read with interest the study by Fish et al (August 2001).1In this study, salmeterol added to inhaled corticosteroids was statistically superior to adding montelukast to inhaled corticosteroids in improving a number of traditional outcome variables such as morning and evening peak expiratory flow (PEF), percent of symptom-free days, percent of rescue-free days, supplemental albuterol use, nighttime awakenings, and some subjective symptoms. Reported daytime wheezing was not different. I am afraid that the design of this study favored this outcome as one of the inclusion criteria was an improvement in FEV1 of at least 12% to β2-agonists. Therefore, the observed results are not surprising, because an improvement of >12% in FEV1 after treatment with β2-agonist was predetermined by these entry criteria. On the contrary, it is noteworthy that montelukast also improved the primary efficacy measure, which was PEF. While the authors claim that the sample size per treatment arm provided >80% power to detect a significant difference of 15 L/min from baseline in the morning PEF, the mean difference between the two treatments observed was only 13.3 L/min. I question the scientific interpretation as well as the clinical significance of their observation. Furthermore, in my view, statistically significant differences such as a reduction of −0.1 nighttime awakenings per week are hardly clinically relevant. Again, I question whether, indeed, salmeterol powder provides better benefit than montelukast. Given the fact that salmeterol itself is a bronchodilator, the observed difference in total supplemental albuterol use of −0.24 puffs (−1.90 vs. −1.66) is also surprisingly small. Finally, the statement that, to the authors’ knowledge, “no other well-controlled studies comparing salmeterol and montelukast have been published,” is difficult to understand, since two of the authors (A. E. and K. A. R.) are coauthors of a very similar study submitted 1.5 months before this one and published approximately 9 months earlier.2 In fact, when looking at the somewhat unclear design of the first study,1 there remains suspicion that part or all of this data1was included in the second study.2

Fish, JE, Israel, E, Murray, JJ, et al (2001) Salmeterol powder provides significantly better benefit than montelukast in asthmatic patients receiving concomitant inhaled corticosteroid therapy.Chest120,423-430
 
Nelson, HS, Busse, WW, Kerwin, E, et al Fluticasone proprionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroids plus montelukast.J Allergy Clin Immunol2000;106,1088-1095
 

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References

Fish, JE, Israel, E, Murray, JJ, et al (2001) Salmeterol powder provides significantly better benefit than montelukast in asthmatic patients receiving concomitant inhaled corticosteroid therapy.Chest120,423-430
 
Nelson, HS, Busse, WW, Kerwin, E, et al Fluticasone proprionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroids plus montelukast.J Allergy Clin Immunol2000;106,1088-1095
 
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