title: Montelukast Does not Maintain Symptom Remission After Topical Steroid Therapy for Eosinophilic Esophagitis.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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. ClinicalTrials.gov no: NCT00511316.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota. Electronic address: alexander.jeffrey14@mayo.edu.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Alexander
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Karthik
authors.initials: K
authors.lastname: Ravi
authors.affiliation: Department of Biostatistics, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Felicity T
authors.initials: FT
authors.lastname: Enders
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Debra M
authors.initials: DM
authors.lastname: Geno
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Kryzer
authors.affiliation: Department of Biostatistics, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Kristin C
authors.initials: KC
authors.lastname: Mara
authors.affiliation: Department of Pathology, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Smyrk
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.
authors.forename: David A
authors.initials: DA
authors.lastname: Katzka
mesh_terms: D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D003521:Cyclopropanes; D065694:Cytochrome P-450 CYP1A2 Inducers; D004311:Double-Blind Method; D057765:Eosinophilic Esophagitis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D060046:Maintenance Chemotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D013256:Steroids; D013440:Sulfides; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D065694:Cytochrome P-450 CYP1A2 Inducers; D020024:Leukotriene Antagonists; D010919:Placebos; D011804:Quinolines; D013256:Steroids; D013440:Sulfides; C093875:montelukast
keywords: Clinical Trial; Drug; Inflammation; Swallow; Treatment