A double-blind, controlled study comparing lafutidine with placebo and famotidine in Japanese patients with mild reflux esophagitis.
OBJECTIVE
This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed.


METHODS
Patients with an endoscopic diagnosis of grade A or B reflux esophagitis according to the Los Angeles classification were randomly assigned to receive lafutidine (20 mg/day), famotidine (40 mg/day), or placebo for 8 weeks.


RESULTS
Of the 584 patients enrolled in the study, 447 were diagnosed to have grade A or B reflux esophagitis by the Endoscopic Assessment Committee. Healing rates at 8 weeks were 71.0% (115/162) in the lafutidine group, 61.4% (86/140) in the famotidine group, and 9.7% (14/145) in the placebo group. Lafutidine was thus demonstrated to be superior to placebo and non-inferior to famotidine. As compared with placebo, lafutidine significantly improved symptoms of heartburn.


CONCLUSIONS
Lafutidine has a high endoscopic healing rate and improves symptoms of heartburn in patients with mild reflux esophagitis. Lafutidine is considered a promising treatment option for mild reflux esophagitis.
Ohara
Shuichi
S
Department of Gastroenterology, Tohoku Rosai Hospital, Sendai, Japan. sohara1122@tohokuh.rofuku.go.jp
Haruma
Ken
K
Kinoshita
Yoshikazu
Y
Kusano
Motoyasu
M
D000081:Acetamides / Q000627:therapeutic use*; D004311:Double-Blind Method; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D004945:Esophagoscopy; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D016896:Treatment Outcome
D000081:Acetamides; D006635:Histamine H2 Antagonists; D010880:Piperidines; D011725:Pyridines; C076948:lafutidine; D015738:Famotidine