Montelukast Does Not Prevent URIs in Preschool Kids

Emma Hitt, PhD

January 04, 2012

January 4, 2012 — In preschool-aged children, a 12-week course of treatment with the selective leukotriene receptor antagonist montelukast did not reduce the incidence of upper respiratory tract infections (URIs) compared with placebo, according to the results of a randomized, placebo-controlled trial.

Eran Kozer, MD, from the Pediatric Emergency Unit at the Assaf Harofeh Medical Center in Zerifin, Israel, and colleagues published their findings online January 4, 2012, in Pediatrics.

Montelukast is an effective treatment for asthma and allergic rhinitis in adult and pediatric patients. Viruses that cause URIs also increase leukotriene levels in nasal secretions, but no studies have evaluated the effect of montelukast for prevention of URIs, the researchers note.

Therefore, Dr. Kozer and colleagues sought to determine whether prophylactic montelukast could reduce the incidence and severity of URIs in 300 healthy children aged 1 to 5 years. More than 85% of children in both groups completed 12 weeks of treatment or placebo.

The primary outcome measure was the number and duration of URI episodes. During the 12-week study, parents recorded in a diary any acute symptoms of URI, use of antipyretic or antibiotic agents, absence from kindergarten, and unscheduled physician office visits.

Parents reported URI symptoms during 30.4% of the weeks for children treated with montelukast and 30.7% for children treated with placebo (P = .83). The duration of URI episodes, on average about 6 to 7 days, did not differ between the groups.

The incidence of fever episodes and the number of days that antibiotics and antipyretics were used was higher with montelukast than with placebo. Regarding these outcomes, the authors note, "the differences between groups were small with marginal statistical significance, and their clinical implication is not clear."

Only about one third of the parents in each group completed a full 12 weeks of the diary, which the authors call a "major limitation" of the study; however, they add that given that there was no trend for improvement with montelukast, "it is unlikely that a larger sample would have shown significant benefits for the drug."

"The attempt to use a leukotriene receptor antagonist stems from the authors' hypothesis that viral infections increase leukotriene levels in nasal mucosa, and therefore an antagonist to this pathway may mitigate the inflammatory response," said Gideon Koren, MD, from the Hospital for Sick Children and professor of pediatrics, pharmacology, pharmacy, and medical genetics at the University of Toronto, Ontario, Canada, who was not involved in the study.

According to Dr. Koren, this large study, which was appropriately powered to answer its research question, was totally negative. "As such, it closes the door on continuation of this line of intervention," he told Medscape Medical News.

"The study clearly shows that the observed increase in nasal secretions of leukotriene in URI is a reaction to, and not the cause of, infection or the mediator that affects severity," he said. "The question as to what other inflammatory mediators may affect this common inflammatory reaction remains open," he added.

"The authors should be congratulated for a large and high-quality effort," Dr. Koren noted. "Often, underpowered studies leave open questions and speculations," he said. "Clearly negative trials are extremely important in preventing repetition of research and avoiding a beta error."

Some of the study authors are employees of or have received grant support from Merck Sharp & Dohme, the manufacturer of montelukast. The study was funded in part by a grant from the company. Dr. Koren has disclosed no relevant financial relationships.

Pediatrics. Published online January 4, 2012. Abstract

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