CURE OF HELICOBACTER-PYLORI INFECTION AND HEALING OF DUODENAL-ULCER -COMPARISON OF PANTOPRAZOLE-BASED ONE-WEEK MODIFIED TRIPLE THERAPY VERSUS 2-WEEK DUAL THERAPY

Objective: Eradication of Helicobacter pylori (H. pylori) is recommend ed as the first-line therapeutic concept for reliable long-term preven tion of duodenal ulcer (DU) relapse. Current treatment regimens vary i n efficacy, complexity, and compliance. To assess the efficacy of pant oprazole in H, pylori eradication in parallel groups of patients using two eradication regimens. Methods: Patients, (18-85 yr old; intention -to-treat, n = 286) with proven DU, positive rapid urease test (biopsy ), and C-13-urea breath test (UBT) were included in a prospective, ran domized, multicenter study. Modified triple therapy consisted of 40 mg pantoprazole b.i.d., 500 mg clarithromycin t.i.d., and 500 mg metroni dazole t.i.d. for 7 days (PCM therapy); dual therapy consisted of 40 m g pantoprazole b.i.d. and 500 mg clarithromycin t.i.d. for 14 days (PC therapy). In both groups 40 mg pantoprazole o.d. was given until day 28 when healing of DU was evaluated endoscopically; H, pylori status w as assessed by UBT on day 56, Results: H, pylori eradication rate was 95% in PCM versus 60% in PC therapy groups (perprotocol population, p < 0.001), and 82% in PCM versus 50% in PC therapy in the intention-to- treat patient population (p < 0.001). The DU healing rate was 98% in t he PCM and 95% in the PC therapy groups (per-protocol population). Bot h regimens were similarly well tolerated. Adverse events in both regim ens included taste disturbance, diarrhea, and increased serum concentr ation of liver enzymes, at an incidence of < 10%, Conclusions: Compare d to 2-wk PC therapy (pantoprazole and clarithromycin), the 1-wk PCM t herapy (pantoprazole, clarithromycin, and metronidazole) is a signific antly superior and highly promising strategy for eradication of H, pyl ori, (Am J Gastroenterol 1998;93: 1919-1924, (C) 1998 by Am. Cell. of Gastroenterology).