Eradication of H-Pylori with pantoprazole, clarithromycin, and metronidazole in duodenal ulcer patients: A head-to-head comparison between two regimens of different duration

Background. The study was conducted to compare the efficacy and tolerabilit y of two pantoprazole-based triple therapies of different length in the era dication of H. pylori. Methods. In this double-blind, multicenter parallel group comparison, H. py lori-positive patients were randomly assigned to either the PCM-7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 50 0 mg bid) or the PCM-14 m group (modified 14 day therapy of the same regime n with metronidazole only given for 10 days due to labeling reasons). H. py lori status was determined by urease test, histology, culture, and C-13-ure a breath test. Treatment outcome was assessed 6 weeks after intake of the l ast study medication. Results. The following eradication rates were achieved: for PCM-7 in the MI TT population 83% (89/107), in the PP population 84% (81/97); for PCM-14 m in MITT 87% (92/106), in PP 88% (91/104). Ulcer healing rates were: for PCM -7 in MITT population 99% (106/107), in the PP population 99% (96/97); for PCM-14 m in MITT 99% (105/106), in PP 99% (103/104). Gastrointestinal sympt oms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patie nts reported adverse events. Five serious adverse events occurred, all unre lated to the study medication. Conclusion. The two pantoprazole-based triple therapies tested in this stud y are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generall y sufficient.