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A New Therapy for Eosinophilic Esophagitis in Adults

Efficacy of Budesonide – Rincinol Gel for 6 Weeks in Patients with Dysphagia

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Neumann, David MD*; Alexander, Glenn MD; Farrugia, Gianrico MD; Ravi, Karthik MD; Talley, Nicholas MD, PhD; Warndahl, Roger PharmD; Alexander, Jeffrey MD

American Journal of Gastroenterology: September 2008 - Volume 103 - Issue - p S8–S9
Supplement Abstracts Submitted for the 73rd Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS
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Mayo Clinic – Rochester, Rochester, MN, Mayo Clinic – Jacksonville, Jacksonville, FL.

Purpose: Topical steroid therapy such as aerosolized fluticasone has been demonstrated to be an effective treatment of Eosinophilic Esophagitis (EE) but may have oral side effects. We hypothesized that delivery of a budesonide gel specifically formulated to increase the contact time of the gel to the esophageal mucosa will result in a greater reduction in clinical symptoms of dysphagia and less oral side effects.

Methods: An oral gel combining budesonide with the mucosal adherent preparation Rincinol (BRG) was compounded. Patients with abnormal Mayo dysphagia questionnaires underwent EGD with biopsies. 16 patients with greater than 15 eos/HPF and solid food dysphagia were enrolled in the study and treated with BRG. Patients were instructed to take BRG 3 mg/10 cc BID. If patients noted marked improvement at one week, they were switched to once daily BRG for 6 weeks; otherwise they were continued on BID BRG for a total of 6 weeks. Dysphagia symptoms and BRG side effects over the last two weeks of treatment were assessed by personal interview. Symptoms were evaluated on a scale of dysphagia resolution: <25%, 25–49%, 50–74%, 75–99% or complete resolution. Those patients, who had previously utilized topical fluticasone for EE, were asked to compare BRG vs topical fluticasone with respect to treatment effect and tolerance.

Results: See Table 1 regarding the baseline clinical features of our EE patients. After 6 weeks of BRG therapy, all patients reported at least a 75% improvement in dysphagia symptomatology. 56% (9/16) of patients reported complete dysphagia resolution and 44% (7/16) reported a 75–99% reduction in dysphagia symptoms. Patients who transitioned from BID to once daily BRG noted no increase in dysphagia symptomatology. There was no significant difference in treatment response observed between the dosing regimens (Table 2). With respect to side effects, 13% (2/16) reported hoarseness and 6% (1/16) unpleasant taste. No oral candidiasis was observed with BRG therapy. Of the patients who had previously received fluticasone for treatment of EE, 38% (3/8) felt BRG was more effective, 62% (5/8) had no preference and none preferred fluticasone. When asked about tolerance, 50% (4/8) of patients tolerated both preparations equally, whereas 25% (2/8) favored fluticasone and 25% (2/8) favored budesonide.

Table 2

Table 2

Table 1

Table 1

Conclusion: BRG effectively relieved symptoms of dysphagia in patients with esophageal eosinophilia with minimal side effects in this study. BRG may also be effective in treating EE patients who have previously failed fluticasone. Further studies should be performed to validate these findings.

© The American College of Gastroenterology 2008. All Rights Reserved.