Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis

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• 作者：Jeffrey A. Alexander^&lowast ; ; ^{alexander.jeffrey14@mayo.edu} ; Karthik Ravi^&lowast ; ; Felicity T. Enders^&Dagger ; ; Debra M. Geno^&lowast ; ; Lori A. Kryzer^&lowast ; ; Kristin C. Mara^&Dagger ; ; Thomas C. Smyrk^§ ; ; David A. Katzka^&lowast ;
• 关键词：Inflammation ; Swallow ; Drug ; Treatment ; Clinical Trial
• 刊名：Clinical Gastroenterology and Hepatology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：15
• 期：2
• 页码：214-221.e2
• 全文大小：669 K
• 卷排序：15

文摘

Montelukast, a cysteinyl leukotriene type-1 receptor blocker, has been shown in small retrospective studies to reduce symptoms in patients with eosinophilic esophagitis (EoE). We performed a randomized, placebo-controlled, double-blind trial to determine whether montelukast maintains symptomatic remission induced by topical steroid therapy in patients with EoE.MethodsWe performed a prospective study of adult patients with EoE (solid-food dysphagia and a peak esophageal eosinophil count of >20 cells/high-powered field) enrolled at the Mayo Clinic in Rochester, Minnesota, from April 2008 through February 2015. All patients had been treated previously for at least 6 weeks with a topical steroid until their symptoms were in remission. Steroids were discontinued and patients then were assigned randomly to groups given montelukast (20 mg/day, n = 20) or placebo (n = 21) for 26 weeks (groups were matched for age, sex, history of allergic disease, reflux symptoms, and endoscopic findings of EoE). Study participants were assessed via a structured telephone interview at weeks 2, 4, 8, 12, 16, 20, and 24. Remission was defined as the absence of solid-food dysphagia.ResultsBased on an intention-to-treat analysis, after 26 weeks, 40.0% of subjects in the montelukast group and 23.8% in the placebo group were in remission. The odds ratio for remission in the montelukast group was 0.48 (95% confidence interval, 0.10–2.16) (P = .33). No side effects were reported from either group.ConclusionsIn a randomized controlled trial of the ability of montelukast to maintain remission in patients in remission from EoE after steroid therapy, we found montelukast to be well tolerated; 40% of patients remained in remission, but this proportion did not differ significantly from that of the placebo group. ClinicalTrials.gov no: NCT00511316.