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Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial

 Eun Hye Kim ; Yong Chan Lee ; Sang Woo Lee ; Hak Yang Kim ; Sei Jin Youn ; Jae Gyu Kim ; Soo Teik Lee ; Hyun Chae Jung ; Dong Ho Lee ; Jin Tae Jung ; Ok-Jae Lee ; Soo-Heon Park ; Myung-Gyu Choi ; Sok Won Han ; Sang-Young Seol ; Hyun Yong Jeong ; Hyun-Soo Kim ; Hwoon-Yong Jung ; Hoon Jai Chun ; Jong-Jae Park ; Young Woon Chang 
 Digestive Diseases and Sciences, Vol.60(6) : 1724~1732, 2015 
Journal Title
 Digestive Diseases and Sciences 
Issue Date
BACKGROUND: There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea. AIM: To evaluate the efficacy of a new-generation histamine-2 receptor antagonist, lafutidine, in comparison with famotidine in patients with reflux esophagitis. METHODS: This was a randomized, double-blind, non-inferiority trial enrolling patients with erosive esophagitis. The efficacy and safety of 20 mg lafutidine (treatment group) were compared with those of 40 mg famotidine (control group) and 20 mg omeprazole (reference group). The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment. The non-inferiority margin was assumed to be -15 %. RESULTS: The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % (101/144) in the lafutidine, 63.45 % (92/145) in the famotidine, and 85.71 % (126/147) in the omeprazole group. The difference in healing rates between the lafutidine and famotidine groups was 6.69 % (95 % confidence interval = [-4.14 to 17.52]). In addition, lafutidine was superior to famotidine in clinical improvement (53.73 % vs. 39.55 %, P = 0.0200). CONCLUSIONS: Lafutidine was non-inferior to famotidine in healing of reflux esophagitis. Lafutidine, however, was superior to famotidine in terms of symptom relief of reflux esophagitis.
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1. 연구논문 > 1. College of Medicine > Dept. of Internal Medicine
Yonsei Authors
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