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Fluticasone can cause histologic response in patients with eosinophilic esophagitis
Patients with eosinophilic esophagitis treated with fluticasone experienced histologic but not symptomatic improvement in a recent study.
In a double blind trial, researchers randomly assigned 42 patients with recently diagnosed eosinophilic esophagitis to receive either 880 mcg aerosolized fluticasone or placebo twice a day for 6 weeks. Telephone interviews were conducted at 2 and 4 weeks to determine compliance, responsiveness and adverse events. All participants were recruited between October 2005 and December 2009 at the Esophageal Clinic at the Mayo Clinic in Rochester, Minn.
More patients in the fluticasone group than the placebo group experienced a reduction in dysphagia by intention-to-treat (57.1% vs. 33.3%, P=.22) and per-protocol (63.2% vs. 46.7%, P=.49) analysis, which included 19 treated patients and 15 who received placebo. Incidents of heartburn and regurgitation also were similar in number between the groups (P=.94 for heartburn; P=.69 for regurgitation.)
A complete histologic response occurred in 13 patients in the fluticasone group, compared with none in the placebo group (P<.001 for both intention-to-treat and per-protocol). Mean esophageal eosinophil counts were 0 in 11 patients. No patients in the placebo group had a count of 2 or less after treatment, compared with 12 of the 13 treated patients. Eosinophil-derived eurotoxin staining also was performed before and after treatment on specimens from 16 treated patients and 13 who received placebo. Results indicated a greater response in the treated group in both intracellular (81.3% vs. 7.7%, P<.001) and extracellular staining (75.0% vs. 7.7%, P<.001).
Reported adverse events included sore throat (10.5% of treated patients and 20.0% of placebo patients; P=.63) and hoarseness (0% of treated patients and 20% of placebo patients; P=.08). Investigators also observed esophageal candidiasis development in 26.3% of fluticasone patients, compared with zero in the placebo group (P=.05).
“The treatment [was] efficacious at decreasing esophageal eosinophilia and eosinophil activity,” the researchers wrote. “This histologic response, however, was not accompanied by a relief of symptomatic dysphagia. We conclude further study is needed regarding dose of therapy, length of therapy and long-term safety of therapy with topical fluticasone, as well as other steroid medications.”
Disclosure: Researcher Jeffrey A. Alexander, MD, serves as a consultant for and has stock ownership in Meritage Pharmacia.