Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients.

Abstract

BACKGROUND:

To date, no adequate data are available on direct comparison of the efficacy of levocetirizine, a recently approved histamine1-antihistamine, with that of a leukotriene antagonist in the treatment of seasonal allergic rhinitis (SAR) symptoms.

OBJECTIVE:

To compare the efficacy of therapeutic doses of 5 mg of levocetirizine and 10 mg of montelukast in ragweed sensitized patients.

METHODS:

A randomized, double-blind, placebo-controlled, parallel-group study was conducted between July and October 2006. Symptomatic patients with SAR were exposed to ragweed pollen under controlled conditions in an environmental exposure chamber for 4 to 5 hours after treatment with 5 mg of levocetirizine, 10 mg of montelukast, or matched placebo on 2 consecutive days. The mean change from baseline in pollen-induced rhinitis symptoms, expressed as a major symptoms complex (MSC) score (sum of scores for rhinorrhea, itchy nose, sniffles, nose blows, sneezes, and watery eyes), in period 1 (first 5 hours after first drug intake) was the primary efficacy outcome.

RESULTS:

A total of 611 patients were screened, of whom 403 were randomized to receive treatment (102 placebo, 152 levocetirizine, and 149 montelukast). The MSC score in period 1 was progressively decreased to a significantly greater extent in the levocetirizine group compared with the montelukast and placebo groups (adjusted mean differences, -2.18 [95% confidence interval, -3.35 to -1.01; P < .001] and -2.22 [95% confidence interval, -3.51 to -0.92; P < .001] for levocetirizine vs montelukast and vs placebo, respectively). The effect of 10 mg of montelukast was not significantly different compared with placebo. Levocetirizine also achieved a significantly faster onset of action within 2.5 hours of administration. Both products were well tolerated.

CONCLUSIONS:

This study in an environmental exposure chamber confirms the therapeutic efficacy of 5 mg of levocetirizine in improving symptoms of SAR, which was superior to 10 mg of montelukast.

• Authors: Piyush Patel, Deepen Patel
• Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 101 Issue 3 Pg. 287-94 (Sep 2008) ISSN: 1081-1206 [Print] United States
• PMID: 18814452 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Acetates
• Cyclopropanes
• Histamine H1 Antagonists, Non-Sedating
• Leukotriene Antagonists
• Quinolines
• Sulfides
• levocetirizine
• montelukast
• Cetirizine

Topics

• Abdominal Pain (chemically induced)
• Acetates (adverse effects, therapeutic use)
• Adolescent
• Adult
• Aged
• Ambrosia (immunology)
• Cetirizine (adverse effects, therapeutic use)
• Cyclopropanes
• Double-Blind Method
• Exanthema (chemically induced)
• Female
• Histamine H1 Antagonists, Non-Sedating (adverse effects, therapeutic use)
• Humans
• Leukotriene Antagonists (adverse effects, therapeutic use)
• Male
• Middle Aged
• Patient Satisfaction
• Quinolines (adverse effects, therapeutic use)
• Rhinitis, Allergic, Seasonal (drug therapy, immunology)
• Sulfides
• Time Factors
• Treatment Outcome