The first blinded placebo-controlled trial of montelukast in EoE demonstrate that it provides no clinical benefit over placebo.
Montelukast, a cysteinyl leukotriene type-1 receptor blocker used in the treatment of bronchial asthma, has been also repeatedly used in patients with eosinophilic esophagitis, both children and adults. Small retrospective studies showed a certain clinical benefit to reduce symptoms in patients with eosinophilic esophagitis (EoE), with no patients achieved histologic response. Additionally, montelukast failed to maintain topic steroid-induced remission in a prospective series of 11 adults with EoE, with reappearance of symptoms and eosinophilic inflammation within a 3-months period. However, high evidence on the potential utility of montelukas for patients with EoE was lacking.
A randomized placebo-controlled trial has been performed to determine whether montelukast maintains symptomatic remission induced by topical steroid therapy in patients with EoE. Fourty one adult patients with EoE, presenting solid food dysphagia and a peak esophageal eosinophil count of over 20 cells/high-powered field, were enrolled at the Mayo Clinic in Rochester Minnesota from April 2008 through February 2015. Treatment with topic steroids were provided for at least 6 weeks until their symptoms were in remission. Patients with esophageal strictures were excluded. Steroids were then discontinued and patients were then randomly assigned to groups given montelukast (20 mg/day) or placebo 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 phone interview at weeks 2,4,8,12,16, 20, and 24. The validated Mayo Dysphagia Questionnaire 30-day version was used to evaluate esophageal symptoms. Remission was defined as the absence of solid food dysphagia.
After 26 weeks of treatment, 40.0% of subjects in the montelukast group and 23.8% in the placebo group presented no symptoms of the disease (based on intention to treat analysis). However, this difference was not statistically significant, and therefore it could be likely cause for random. The odds ratio for remission in the montelukast group was 0.48 (95% CI, 0.10–2.16) (P=0.33). Eosinophilic inflammation was found in endoscopic biopsies of all patients who were explored after montelukast treatment. No side effects were reported from either group.
This is the only blinded placebo-controlled trial of montelukast in the treatment of EoE. The authors evaluated the effectiveness of montelukast at maintaining symptomatic remission
induced by topical steroid therapy. At multiple time points for a duration of 6 months, there was no statistically significant benefit of montelukast in maintaining symptomatic remission induced by topical steroid therapy, with a similar proportion of patients maintaining in symptomatic remission with no differences if they received montelukast of placebo.
Alexander JA, et al. Montelukast Does not Maintain Symptom Reductions Following Topical Steroid Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2016 Sep 17. doi: 10.1016/j.cgh.2016.09.013.
Read more at: https://www.ncbi.nlm.nih.gov/pubmed/27650328