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, Young Woon Chang, Jong Jae Park, Hoon-Jai Chun, Hwoon Yong Jung, Hyun Soo Kim, Hyun Yong Jeong, Sang Young Seol, Sok Won Han, Myung Gyu Choi, Soo Heon Park, Ok Jae Lee, Jin Tae Jung, Dong Ho Lee, Hyun Chae Jung, Soo Teik Lee, Jae Gyu Kim, Sei Jin Youn, Hak Yang KimSang Woo Lee

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5 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1724-1732
Number of pages9
JournalDigestive Diseases and Sciences
Volume60
Issue number6
DOIs
Publication statusPublished - 2015 Dec 23

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Keywords

  • Famotidine
  • Lafutidine
  • Omeprazole
  • Reflux esophagitis

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

Kim, E. H., Lee, Y. C., Chang, Y. W., Park, J. J., Chun, H-J., Jung, H. Y., Kim, H. S., Jeong, H. Y., Seol, S. Y., Han, S. W., Choi, M. G., Park, S. H., Lee, O. J., Jung, J. T., Lee, D. H., Jung, H. C., Lee, S. T., Kim, J. G., Youn, S. J., ... Lee, S. W. (2015). Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial. Digestive Diseases and Sciences, 60(6), 1724-1732. https://doi.org/10.1007/s10620-014-3489-4