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A double-blind, controlled study comparing lafutidine with placebo and famotidine in Japanese patients with mild reflux esophagitis.

Author(s): Ohara S, Haruma K, Kinoshita Y, Kusano M

Affiliation(s): Department of Gastroenterology, Tohoku Rosai Hospital, Sendai, Japan. sohara1122@tohokuh.rofuku.go.jp

Publication date & source: 2010-12, J Gastroenterol., 45(12):1219-27. Epub 2010 Jul 15.

Publication type: Clinical Trial, Phase III; Comparative Study; Randomized Controlled Trial

PURPOSE: This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed. METHODS: Patients with an endoscopic diagnosis of grade A or B reflux esophagitis according to the Los Angeles classification were randomly assigned to receive lafutidine (20 mg/day), famotidine (40 mg/day), or placebo for 8 weeks. RESULTS: Of the 584 patients enrolled in the study, 447 were diagnosed to have grade A or B reflux esophagitis by the Endoscopic Assessment Committee. Healing rates at 8 weeks were 71.0% (115/162) in the lafutidine group, 61.4% (86/140) in the famotidine group, and 9.7% (14/145) in the placebo group. Lafutidine was thus demonstrated to be superior to placebo and non-inferior to famotidine. As compared with placebo, lafutidine significantly improved symptoms of heartburn. CONCLUSIONS: Lafutidine has a high endoscopic healing rate and improves symptoms of heartburn in patients with mild reflux esophagitis. Lafutidine is considered a promising treatment option for mild reflux esophagitis.

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