TRIPLE VERSUS DUAL THERAPY FOR ERADICATING HELICOBACTER-PYLORI AND PREVENTING ULCER RECURRENCE - A RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF LANSOPRAZOLE, CLARITHROMYCIN, AND OR AMOXICILLIN IN DIFFERENT DOSING REGIMENS/

Objective: The efficacy and safety of dual and triple therapies with a proton pump inhibitor and antibiotic(s) for therapy of Helicobacter p ylori-associated duodenal ulcer disease have been compared using resul ts from independent studies using different methods and regimens, maki ng interpretation difficult. In a large, double-blind, multicenter stu dy conducted in the United States, we compared a triple therapy regime n with four dual therapy and one monotherapy regimens in the eradicati on of H. pylori and the prevention of ulcer recurrence. Methods: Patie nts with active duodenal ulcer disease or history of duodenal ulcer di sease within the past year and H. pylori infection were randomized to receive one of six 14-day treatment regimens: lansoprazole 30 mg, clar ithromycin 500 mg, and amoxicillin 1 gm b.i.d.; lansoprazole 30 mg b.i .d. and either-clarithromycin 500 mg b.i.d. or t.i.d.; lansoprazole 30 mg b.i.d. or t.i.d. with amoxicillin 1 gm t.i.d.; or lansoprazole 30 mg t.i.d. alone. No additional acid suppression therapy followed eradi cation therapy. Primary efficacy endpoints were eradication of H. pylo ri and ulcer recurrence. Results: Of 396 patients enrolled in the stud y, 352 met the entry criteria for duodenal ulcer status and H. pylori positivity. At 4-6 wk after the end of therapy, H. pylori was eradicat ed from 94% (44 of 47) of patients receiving lansoprazole, clarithromy cin, and amoxicillin triple therapy, 77% (39 of 51) of those receiving lansoprazole t.i.d/amoxicillin t.i.d., 75% (36 of 48) of those receiv ing lansoprazole b.i.d./clarithromycin t.i.d., 57% (28 of 49) of those receiving lansoprazole b.i.d./clarithromycin b.i.d., 53% (26 of 49) o f those receiving lansoprazole b.i.d./Jamoxicillin Lid, and 2% (1 of 5 3) of those receiving lansoprazole monotherapy (p less than or equal t o 0.05, triple therapy vs each dual therapy and each dual therapy vs m onotherapy). Of those patients who were documented as free of ulcer at 4-6 wk after treatment, ulcers recurred within 6 months in 7% of pati ents receiving triple therapy, as compared with 13-23% of patients rec eiving dual therapy, and 69% of patients receiving lansoprazole monoth erapy. Patients who were H. pylori negative at 4-6 wk after treatment were less likely to have an ulcer recurrence than were patients who we re H. pylori positive (11% [10 of 95] vs 47% [20 of 43], respectively, across treatment groups). For triple therapy and dual therapy, a simi lar proportion of patients reported a drug-related adverse event (23% vs 17-33%, respectively). Conclusions: In patients with active or a re cent history of duodenal ulcer, a 14-day course of lansoprazole-based triple therapy without additional acid suppression therapy is highly e ffective in the eradication of H. pylori and in preventing ulcer recur rence. Among the dual therapies, higher eradication rates occurred whe n lansoprazole (with amoxicillin) or clarithromycin (with lansoprazole ) was administered t.i.d. vs b.i.d., but the rates were still signific antly lower than with lansoprazole triple therapy with all three drugs administered b.i.d. (C) 1998 by Am. Coll. of Gastroenterology.