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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea, eunhye31@yuhs.ac.
authors.forename: Eun Hye
authors.initials: EH
authors.lastname: Kim
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Lee
authors.forename: Young Woon
authors.initials: YW
authors.lastname: Chang
authors.forename: Jong-Jae
authors.initials: JJ
authors.lastname: Park
authors.forename: Hoon Jai
authors.initials: HJ
authors.lastname: Chun
authors.forename: Hwoon-Yong
authors.initials: HY
authors.lastname: Jung
authors.forename: Hyun-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Hyun Yong
authors.initials: HY
authors.lastname: Jeong
authors.forename: Sang-Young
authors.initials: SY
authors.lastname: Seol
authors.forename: Sok Won
authors.initials: SW
authors.lastname: Han
authors.forename: Myung-Gyu
authors.initials: MG
authors.lastname: Choi
authors.forename: Soo-Heon
authors.initials: SH
authors.lastname: Park
authors.forename: Ok-Jae
authors.initials: OJ
authors.lastname: Lee
authors.forename: Jin Tae
authors.initials: JT
authors.lastname: Jung
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Hyun Chae
authors.initials: HC
authors.lastname: Jung
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lee
authors.forename: Jae Gyu
authors.initials: JG
authors.lastname: Kim
authors.forename: Sei Jin
authors.initials: SJ
authors.lastname: Youn
authors.forename: Hak Yang
authors.initials: HY
authors.lastname: Kim
authors.forename: Sang Woo
authors.initials: SW
authors.lastname: Lee
mesh_terms: D000081:Acetamides / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D004945:Esophagoscopy; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010880:Piperidines / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D056910:Republic of Korea; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000081:Acetamides; D000897:Anti-Ulcer Agents; D010880:Piperidines; D011725:Pyridines; C076948:lafutidine; D015738:Famotidine; D009853:Omeprazole