RANITIDINE BISMUTH CITRATE PLUS CLARITHROMYCIN - A DUAL THERAPY REGIMEN FOR PATIENTS WITH DUODENAL-ULCER

Background. The combination of ranitidine bismuth citrate (RBC) and cl arithromycin (CLR) was compared with each treatment alone for the erad ication of H. pylori and healing of duodenal ulcers in patients infect ed with H. pylori. Methods. This two-phase, randomized, double-blind, placebo-controlled, multicenter study evaluated 203 patients with an a ctive duodenal ulcer treated with either (1) RBC 400 mg BID for 4 week s plus CLR 500 mg TID for the first 2 weeks; (2) RBC 400 mg BID for 4 weeks plus placebo TID for the first 2 weeks; (3) placebo BID for 4 we eks plus CLR 500 mg TID for the first 2 weeks; or (4) placebo BID for 4 weeks plus placebo TID for the first 2 weeks. Patients with healed u lcers after treatment entered a 24-week observation phase for the asse ssment of H. pylori and ulcer relapse. Results. Four-week ulcer healin g rates were higher with RBC + CLR (71%) and RBC alone (66%) compared with placebo (15%; p < 0.05) and CLR alone (49%). H. pylori eradicatio n rates were significantly higher with RBC + CLR (86%) compared with R BC alone (0%, p <.001) or CLR alone (24%, p <.001). Ulcer recurrence r ates after 6 months were lower in patients eradicated of H. pylori inf ection (17%) compared with patients who remained infected (43%). All t reatments were well tolerated. Conclusions. Ranitidine bismuth citrate plus clarithromycin is a simple, convenient, and well-tolerated dual therapy regimen that is effective in eradicating H. pylori and healing duodenal ulcers in patients infected with H. pylori. The eradication of H. pylori in patients with healed ulcers significantly reduces the rate of ulcer relapse.