Efficacy and Tolerability of Montelukast as a Therapeutic Agent for Severe Atopic Dermatitis in Adults

Sir, (20% reduction) compared to the placebo group measThe pathogenesis of atopic dermatitis (AD) is only ured by SCORAD index, as shown in Fig. 1. The partly understood. Evidence supports the potential role combined score of daytime pruritus and sleep loss of soluble mediators as leukotrienes (LTs) (1). Drugs remained similar throughout the study and was not that selectively inhibit the formation or action of LTs statistically signiŽ cant between the two treatments (F = have been introduced as a new form of anti0.08 p =0.92) and the diVerent times of observation in ammatory therapy in asthma. Montelukast is an (F =1.95 p =0.18). The blood-chemistry tests conducted antileukotriene agent known as CysLT1 receptor antagat the end of treatment revealed no changes in any of onist. Cysteinyl LTs (LTC4, LTD4, LTE4) are potent the studied patients and no adverse eVects were observed smooth muscle constrictors, and contribute to the onset by the investigator or reported by the patient, thereby of in ammation by their ability to cause plasma extraconŽ rming the tolerability of montelukast. vasation and eosinophil recruitment (2). The objective of our study was to evaluate the eYcacy and tolerability DISCUSSION of montelukast as a therapeutic agent for severe AD in adults. Montelukast is generally a safe drug during long-term treatment; side eVects are minimal (4). Indeed, in our MATERIAL AND METHODS study montelukast was well tolerated, conŽ rming observations by other authors of the safety of this drug (4–6). We enrolled 20 adult male patients with severe AD according This could be particularly relevant for patients aVected to the SCORAD index (severe AD: mean objective score > 40) with AD who may need treatment for long periods of (3). Their ages ranged from 18 to 28 years (mean age 22 ± 3.7). One month before treatment, the patients were asked to time. The anti-in ammatory potential of anti-LTs in discontinue all medication except emollients. The study was asthma has been conŽ rmed in a number of studies (7, approved by the ethics committee and subjects signed an 8). The role of the LTs in AD remains unclear. A informed consent form to participate in the study. Exclusion prolonged elevation of the urinary levels of LTE4 has criteria were: pregnancy, pregnancy potential and current lactation; a history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin. Subjects were randomized into two groups of 10 to receive montelukast 10mg or placebo for 6 weeks in a double-blind study. Furthermore, during the study, all subjects were not allowed other treatment for AD. EYcacy was assessed by SCORAD index and subjective symptoms were evaluated separately at baseline, and after 3 and 6 weeks. The SCORAD index combines objective signs (extent and intensity of lesions) and subjective (daytime pruritus and sleep loss) criteria. Evaluations were made at each visit by the same investigator for each patient. Blood tests were performed for total blood cell count and blood chemistry (aspartate transaminase, total bilirubin, creatinine and urea). Baseline mean values were compared using Student’s t-test for unpaired samples. The eYcacy of the two treatments at diVerent times was evaluated using a split-plot analysis of variance (ANOVA). Comparison between t0 and t2 (time of treatment at baseline and end of the study) was evaluated with Student’s t-test for unpaired samples.