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Cited 5 time in webofscience Cited 6 time in scopus
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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

Authors
Kim, Eun HyeLee, Yong ChanChang, Young WoonPark, Jong-JaeChun, Hoon JaiJung, Hwoon-YongKim, Hyun-SooJeong, Hyun YongSeol, Sang-YoungHan, Sok WonChoi, Myung-GyuPark, Soo-HeonLee, Ok-JaeJung, Jin TaeLee, Dong HoJung, Hyun ChaeLee, Soo TeikKim, Jae GyuYoun, Sei JinKim, Hak YangLee, Sang Woo
Issue Date
Jun-2015
Publisher
SPRINGER
Keywords
Lafutidine; Famotidine; Omeprazole; Reflux esophagitis
Citation
DIGESTIVE DISEASES AND SCIENCES, v.60, no.6, pp 1724 - 1732
Pages
9
Indexed
SCI
SCIE
SCOPUS
Journal Title
DIGESTIVE DISEASES AND SCIENCES
Volume
60
Number
6
Start Page
1724
End Page
1732
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/7859
DOI
10.1007/s10620-014-3489-4
ISSN
0163-2116
1573-2568
Abstract
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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Park, Jong Jae
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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