P Unge1. 1. Department of Medicine, Länssjukhuset Gävle Sandviken, Gävle, Sweden. peter.unge@lsgs.lg.se
Abstract
OBJECTIVE: In three studies, the two most successful regimens in the MACH1 study (omeprazole-amoxycillin-clarithromycin (OAC) and omeprazole-metronidazole-clarithromycin (OMC)) were investigated further. DESIGN: Double-blind, randomized, international, multi-centre studies with parallel groups. SETTING: The studies were performed at centres in France, Germany, Ireland, Norway, Sweden and the UK (MACH2), Canada (DU-MACH) and Germany, Hungary and Poland (GU-MACH). PARTICIPANTS AND INTERVENTIONS: In MACH2, the influence of omeprazole on eradication was investigated in patients with duodenal ulcers in remission, using OAC, AC, OMC and MC. In DU-MACH and GU-MACH, eradication and relapse rates were investigated in patients with active peptic ulcers, using: OAC, OMC and omeprazole alone. MAIN OUTCOME MEASURES: Eradication of Helicobacter pylori. In patients with active peptic ulcer, ulcer healing was also assessed. RESULTS: In MACH2 (n = 514, intention-to-treat (ITT) analysis), the addition of omeprazole to AC increased the eradication rate from 26 to 94%. The corresponding increase for MC/ OMC was from 69 to 87%. The efficacy of the AC and OAC regimens was unaffected by primary metronidazole resistance, while that of MC was halved and that of OMC reduced by 15%. Clarithromycin resistance was uncommon. In DU-MACH and GU-MACH (n = 146 and 145, ITT analysis), eradication rates were high with both regimens. Ulcer healing rates were also high in all treatment groups; ulcer relapse was significantly less frequent in the OAC and OMC groups. All regimens were well tolerated. CONCLUSION:Omeprazole triple therapy is highly effective in patients with active or healed peptic ulcer disease, and is well tolerated.
RCT Entities:
OBJECTIVE: In three studies, the two most successful regimens in the MACH1 study (omeprazole-amoxycillin-clarithromycin (OAC) and omeprazole-metronidazole-clarithromycin (OMC)) were investigated further. DESIGN: Double-blind, randomized, international, multi-centre studies with parallel groups. SETTING: The studies were performed at centres in France, Germany, Ireland, Norway, Sweden and the UK (MACH2), Canada (DU-MACH) and Germany, Hungary and Poland (GU-MACH). PARTICIPANTS AND INTERVENTIONS: In MACH2, the influence of omeprazole on eradication was investigated in patients with duodenal ulcers in remission, using OAC, AC, OMC and MC. In DU-MACH and GU-MACH, eradication and relapse rates were investigated in patients with active peptic ulcers, using: OAC, OMC and omeprazole alone. MAIN OUTCOME MEASURES: Eradication of Helicobacter pylori. In patients with active peptic ulcer, ulcer healing was also assessed. RESULTS: In MACH2 (n = 514, intention-to-treat (ITT) analysis), the addition of omeprazole to AC increased the eradication rate from 26 to 94%. The corresponding increase for MC/ OMC was from 69 to 87%. The efficacy of the AC and OAC regimens was unaffected by primary metronidazole resistance, while that of MC was halved and that of OMC reduced by 15%. Clarithromycin resistance was uncommon. In DU-MACH and GU-MACH (n = 146 and 145, ITT analysis), eradication rates were high with both regimens. Ulcer healing rates were also high in all treatment groups; ulcer relapse was significantly less frequent in the OAC and OMC groups. All regimens were well tolerated. CONCLUSION:Omeprazole triple therapy is highly effective in patients with active or healed peptic ulcer disease, and is well tolerated.
Authors: Iyad M Subei; Hector José Cardona; Ernesto Bachelet; Emerson Useche; Anthony Arigbabu; Adnan Abu Hammour; Tom Miller Journal: Dig Dis Sci Date: 2007-04-27 Impact factor: 3.487