AN ALTERNATIVE NON-MACROLIDE, NON-IMIDAZOLE TREATMENT REGIMEN FOR CURING HELICOBACTER-PYLORI AND DUODENAL-ULCERS - RANITIDINE BISMUTH CITRATE PLUS AMOXICILLIN

Background. Because patients who fail to be cured of H. pylori infecti on following macrolide or imidazole therapy are difficult to treat, th ere is a clear need for a reasonably effective and simple second-line treatment regimen. The purpose of these two studies was to evaluate th e efficacy of ranitidine bismuth citrate (RBC) plus amoxicillin for th e cure of H. pylori infection and for healing duodenal ulcers and prev enting ulcer relapse. Materials and Methods. Two identically designed randomized, double-blind, double-dummy studies were conducted in patie nts with an H. pylori-associated duodenal ulcer. Patients were treated with either RBC 400 mg bid for 4 weeks plus amoxicillin 500 mg qid fo r 2 weeks, RBC 400 mg bid for 4 weeks and placebo qid for 2 weeks, pla cebo bid for 4 weeks and amoxicillin 500 mg qid for 2 weeks, or placeb o bid for 4 weeks and placebo qid for 2 weeks. Patients with healed ul cers after 4 weeks of treatment were eligible for entry into a 24-week observation phase for the assessment of H. pylori status (culture, hi stology, and CLOtest(TM)) and ulcer relapse. Results. A total of 229 p atients with confirmed H. pylori infection at baseline were evaluated. Of these, 132 whose ulcers had healed entered the 24-week posttreatme nt observation phase. The combination of RBC plus amoxicillin resulted in higher H. pylori cure rates (55%) and higher duodenal ulcer healin g (74%) than did either treatment alone. All treatments were well tole rated. Conclusions. The combination of ranitidine bismuth citrate plus amoxicillin cures H. pylori infection in more than half of the patien ts treated. This treatment regimen men shows promise as the basis for future non-macrolide, non-imidazole triple therapy regimens for curing H. pylori infection. Such regimens may be appropriate second-line tre atment for patients who are resistant to or who are unable to tolerate macrolide-or imidazole-containing therapies.