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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

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, etc.

Dig Dis Sci. 2015 Jun;60(6):1724-32.

PMID: 25532503

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP118288087	Lafutidine		118288-08-7	Price

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