The efficacy and safety of dual and triple
therapies with a
proton pump inhibitor and
antibiotic(s) for
therapy of Helicobacter pylori-associated
duodenal ulcer disease have been compared using results from independent studies using different methods and regimens, making interpretation difficult. In a large, double-blind, multicenter study conducted in the United States, we compared a triple
therapy regimen with four dual
therapy and one monotherapy regimens in the eradication of H. pylori and the prevention of
ulcer recurrence.
METHODS: RESULTS: Of 396 patients enrolled in the study, 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 eradicated from 94% (44 of 47) of patients receiving
lansoprazole,
clarithromycin, 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 receiving
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) of those receiving
lansoprazole b.i.d./
amoxicillin t.i.d., and 2% (1 of 53) of those receiving
lansoprazole monotherapy (p < or = 0.05, triple
therapy vs each dual
therapy and each dual
therapy vs monotherapy). Of those patients who were documented as free of
ulcer at 4-6 wk
after treatment,
ulcers recurred within 6 months in 7% of patients receiving triple
therapy, as compared with 13-23% of patients receiving dual
therapy, and 69% of patients receiving
lansoprazole monotherapy. Patients who were H. pylori negative at 4-6 wk
after treatment were less likely to have an
ulcer recurrence than were patients who were H. pylori positive (11% [10 of 95] vs 47% [20 of 43], respectively, across treatment groups). For triple
therapy and dual
therapy, a similar proportion of patients reported a
drug-related adverse event (23% vs 17-33%, respectively).
CONCLUSIONS: