BACKGROUND AND AIMS: Lafutidine is a novel H(2)-receptor antagonist with gastroprotective activity that includes enhancement of gastric mucosal blood flow. The aim of the present study was to test the efficacy of 7- or 14-day lafutidine-clarithromycin-amoxicillin therapy versus a lansoprazole-based regimen for Helicobacter pylori eradication. METHODS:Four hundred and sixty-three patients with H. pylori-infected peptic ulcer disease were randomized to one of four regimens: (1) lafutidine (20 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LFT group) or (2) for 14 days (the 14LFT group); (3) lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LPZ group); or (4) for 14 days (the 14LPZ group). The eradication rates, drug compliance, and adverse effects among the four regimens were compared. RESULTS: The eradication rates by the intention-to-treat and per-protocol analyses in the 7LFT and 7LPZ groups were 76.5% and 81.6%, and 76.9% and 82.0% (p = .94 and .95), respectively. The eradication rates by intention-to-treat and per-protocol analyses in the 14LFT and 14LPZ groups were 78.2% and 82.2%, and 80.4% and 85.9% (p = .70 and .49), respectively. The treatment duration for 7 days or 14 days did not affect the eradication rates. In addition, the adverse effect rates and discontinuation rates were similar among the four groups. Furthermore, the ulcer cure rate and symptom response rate were similar in the lafutidine and lansoprazole groups. CONCLUSION: The results of this study showed that lafutidine-clarithromycin-amoxicillin therapy was a safe and effective as lansoprazole-based triple therapy for the eradication rate of H. pylori, and could be considered as an additional treatment option.
RCT Entities:
BACKGROUND AND AIMS: Lafutidine is a novel H(2)-receptor antagonist with gastroprotective activity that includes enhancement of gastric mucosal blood flow. The aim of the present study was to test the efficacy of 7- or 14-day lafutidine-clarithromycin-amoxicillin therapy versus a lansoprazole-based regimen for Helicobacter pylori eradication. METHODS: Four hundred and sixty-three patients with H. pylori-infected peptic ulcer disease were randomized to one of four regimens: (1) lafutidine (20 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LFT group) or (2) for 14 days (the 14LFT group); (3) lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LPZ group); or (4) for 14 days (the 14LPZ group). The eradication rates, drug compliance, and adverse effects among the four regimens were compared. RESULTS: The eradication rates by the intention-to-treat and per-protocol analyses in the 7LFT and 7LPZ groups were 76.5% and 81.6%, and 76.9% and 82.0% (p = .94 and .95), respectively. The eradication rates by intention-to-treat and per-protocol analyses in the 14LFT and 14LPZ groups were 78.2% and 82.2%, and 80.4% and 85.9% (p = .70 and .49), respectively. The treatment duration for 7 days or 14 days did not affect the eradication rates. In addition, the adverse effect rates and discontinuation rates were similar among the four groups. Furthermore, the ulcer cure rate and symptom response rate were similar in the lafutidine and lansoprazole groups. CONCLUSION: The results of this study showed that lafutidine-clarithromycin-amoxicillin therapy was a safe and effective as lansoprazole-based triple therapy for the eradication rate of H. pylori, and could be considered as an additional treatment option.