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

Jeffrey A. Alexander, Karthik Ravi, Felicity T. Enders, Debra M. Geno, Lori A. Kryzer, Kristin C. Mara, Thomas C. Smyrk, David A. Katzka

Research output: Contribution to journalArticlepeer-review

34 Scopus citations


Background & Aims 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. Methods We 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. Results Based 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. Conclusions In 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. no: NCT00511316.

Original languageEnglish (US)
Pages (from-to)214-221.e2
JournalClinical Gastroenterology and Hepatology
Issue number2
StatePublished - Feb 1 2017


  • Clinical Trial
  • Drug
  • Inflammation
  • Swallow
  • Treatment

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


Dive into the research topics of 'Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis'. Together they form a unique fingerprint.

Cite this