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

Research output: Contribution to journalArticle

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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
StatePublished - 23 Dec 2015

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Famotidine
Peptic Esophagitis
Omeprazole
Endoscopy
Histamine Receptors
Esophagitis
lafutidine
Korea
Therapeutics
Confidence Intervals
Safety
Control Groups

Keywords

  • Famotidine
  • Lafutidine
  • Omeprazole
  • Reflux esophagitis

Cite this

Kim, Eun Hye ; Lee, Yong Chan ; Chang, Young Woon ; Park, Jong Jae ; Chun, Hoon Jai ; Jung, Hwoon Yong ; Kim, Hyun Soo ; Jeong, Hyun Yong ; Seol, Sang Young ; Han, Sok Won ; Choi, Myung Gyu ; Park, Soo Heon ; Lee, Ok Jae ; Jung, Jin Tae ; Lee, Dong Ho ; Jung, Hyun Chae ; Lee, Soo Teik ; Kim, Jae Gyu ; Youn, Sei Jin ; Kim, Hak Yang ; Lee, Sang Woo. / Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis : A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial. In: Digestive Diseases and Sciences. 2015 ; Vol. 60, No. 6. pp. 1724-1732.
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title = "Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis: A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial",
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.",
keywords = "Famotidine, Lafutidine, Omeprazole, Reflux esophagitis",
author = "Kim, {Eun Hye} and Lee, {Yong Chan} and Chang, {Young Woon} and Park, {Jong Jae} and Chun, {Hoon Jai} and Jung, {Hwoon Yong} and Kim, {Hyun Soo} and Jeong, {Hyun Yong} and Seol, {Sang Young} and Han, {Sok Won} and Choi, {Myung Gyu} and Park, {Soo Heon} and Lee, {Ok Jae} and Jung, {Jin Tae} and Lee, {Dong Ho} and Jung, {Hyun Chae} and Lee, {Soo Teik} and Kim, {Jae Gyu} and Youn, {Sei Jin} and Kim, {Hak Yang} and Lee, {Sang Woo}",
year = "2015",
month = "12",
day = "23",
doi = "10.1007/s10620-014-3489-4",
language = "English",
volume = "60",
pages = "1724--1732",
journal = "Digestive diseases and sciences",
issn = "0163-2116",
publisher = "Springer New York",
number = "6",

}

Kim, EH, Lee, YC, Chang, YW, Park, JJ, Chun, HJ, Jung, HY, Kim, HS, Jeong, HY, Seol, SY, Han, SW, Choi, MG, Park, SH, Lee, OJ, Jung, JT, Lee, DH, Jung, HC, Lee, ST, Kim, JG, Youn, SJ, Kim, HY & Lee, SW 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, vol. 60, no. 6, pp. 1724-1732. https://doi.org/10.1007/s10620-014-3489-4

Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis : A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial. / Kim, Eun Hye; Lee, Yong Chan; Chang, Young Woon; Park, Jong Jae; Chun, Hoon Jai; Jung, Hwoon Yong; Kim, Hyun Soo; Jeong, Hyun Yong; Seol, Sang Young; Han, Sok Won; Choi, Myung Gyu; Park, Soo Heon; Lee, Ok Jae; Jung, Jin Tae; Lee, Dong Ho; Jung, Hyun Chae; Lee, Soo Teik; Kim, Jae Gyu; Youn, Sei Jin; Kim, Hak Yang; Lee, Sang Woo.

In: Digestive Diseases and Sciences, Vol. 60, No. 6, 23.12.2015, p. 1724-1732.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of Lafutidine Versus Famotidine in Patients with Reflux Esophagitis

T2 - A Multi-Center, Randomized, Double-Blind, Non-inferiority Phase III Trial

AU - Kim, Eun Hye

AU - Lee, Yong Chan

AU - Chang, Young Woon

AU - Park, Jong Jae

AU - Chun, Hoon Jai

AU - Jung, Hwoon Yong

AU - Kim, Hyun Soo

AU - Jeong, Hyun Yong

AU - Seol, Sang Young

AU - Han, Sok Won

AU - Choi, Myung Gyu

AU - Park, Soo Heon

AU - Lee, Ok Jae

AU - Jung, Jin Tae

AU - Lee, Dong Ho

AU - Jung, Hyun Chae

AU - Lee, Soo Teik

AU - Kim, Jae Gyu

AU - Youn, Sei Jin

AU - Kim, Hak Yang

AU - Lee, Sang Woo

PY - 2015/12/23

Y1 - 2015/12/23

N2 - 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.

AB - 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.

KW - Famotidine

KW - Lafutidine

KW - Omeprazole

KW - Reflux esophagitis

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U2 - 10.1007/s10620-014-3489-4

DO - 10.1007/s10620-014-3489-4

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