title: Comparison of proton pump inhibitor-based triple therapy with losec and the generic drug, Omepradex, for efficacy of Helicobacter pylori eradication.
abstract: Triple therapy with a proton pump inhibitor (PPI), amoxicillin, and clarithromycin is widely accepted in Israel for Helicobacter pylori eradication. Recently, a generic drug for omeprazole was introduced to the market, but its efficacy as a PPI was questioned. The aim of the study was to compare eradication efficacy of triple therapy-based regimens with Losec (Astra-Zeneca, Sweden) and the generic form, Omepradex (Dexxon, Israel). People belonging to Clalit Health Services (CHS), the biggest health insurance provider in Israel, and receiving omeprazole (Losec or Omepradex) for 7 days (assumed to be Helicobacter pylori eradication purposes), between 1.1.2001 and 31.12.2001, were retrieved from the CHS central computer. Of 450 patients (287 in the Losec group and 163 in the Omepradex group), 97 (21.6%) underwent 13C-urea breath test (13CUBT) for validation of Helicobacter pylori successful eradication and participated in the study. They were all treated with triple therapy with omeprazole, amoxicillin, and clarithromycin, and were stratified according to the PPI used: Group A, Losec; and Group B, Omepradex. Positivity of 13CUBT was computed. Sixty-one (21.25%) and 36 (22.08%) patients in Groups A and B, respectively, underwent 13 CUBT for validation of successful Helicobacter pylori eradication (NS). In Group A 41 of 61 patients (67.21%) had a negative 13CUBT, in comparison with 26 of 36 (72.22%) in Group B (NS). Using logistic regression analysis all confounding factors were found to be noncontributory to the discrimination between negative (successful eradication) and positive (failed eradication) 13CUBT. There is no statistically significant difference between Losec and the generic drug Omepradex as part of a PPI-based triple therapy for eradication efficacy of Helicobacter pylori.
authors.affiliation: Department of Gastroenterology, Rabin Medical Center, Beilinson Campus, Israel. yniv@clalit.org.il
authors.forename: Yaron
authors.initials: Y
authors.lastname: Niv
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole