Helicobacter pylori and early duodenal ulcer status post-treatment: a review

Background. Data submit-red to the FDA were reviewed to analyze the relatio nship between Helicobacter pylori infection and the incidence of early duod enal ulcers, within 6 weeks, following treatment. Materials and Methods, Retrospective analyzes were performed on data from t hree H. pylori development programs submitted to the FDA: ranitidine-bismut h-citrate (RBC), lansoprazole (L) and omeprazole (O). Efficacy assessments for the RBC, L and O programs were made at end of a 4-week treatment period , 4-6 weeks following the end of a 14-day treatment period, and 4 weeks fol lowing the end of a 4-week treatment period, respectively. Results. Overall, there was a 15%, 21% and 23% decrease in the number of pa tients in the RBC, L and O programs, respectively, with ulcers among H. pyl ori cleared/eradicated patients post-treatment compared with patients with persistent infection. Among patients who did not have cleared/eradicated H. pylori in the RBC and O programs, where antisecretory agents were continue d beyond the antimicrobial treatment period, the number of ulcers was lower in the antisecretory plus antimicrobial subgroups compared with the antimi crobial alone subgroups (37% vs. 46% for RBC and 33% vs. 42% for O). Among patients with cleared/eradicated H. pylori, the number of patients with ulc ers in the antimicrobial alone subgroups and antisecretory plus antimicrobi al subgroups were similar within each program. Antimicrobials alone had sig nificantly lower rates of ulcers among patients with cleared/eradicated H. pylori as compared with patients without clearance/eradication. Conclusions. The early incidence of duodenal ulcers is significantly decrea sed in patients with H. pylori clearance/eradication.