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Eradication of H. pylori with Pantoprazole, Clarithromycin, and Metronidazole in Duodenal Ulcer Patients: A Head‐to‐Head Comparison Between Two Regimens of Different Duration
Author(s) -
Dammann HansGerd,
Fölsch Ulrich R.,
Hahn Eckhart G.,
Von Kleist DetlefHasso,
Klör HansUlrich,
Kirchner Thomas,
Strobel Sonja,
Kist Manfred
Publication year - 2000
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1046/j.1523-5378.2000.00006.x
Subject(s) - pantoprazole , medicine , tolerability , clarithromycin , rapid urease test , gastroenterology , regimen , metronidazole , helicobacter pylori , population , adverse effect , breath test , gastritis , antibiotics , omeprazole , environmental health , microbiology and biotechnology , biology
Background. The study was conducted to compare the efficacy and tolerability of two pantoprazole‐based triple therapies of different length in the eradication of H. pylori. Methods. In this double‐blind, multicenter parallel group comparison, H. pylori ‐positive patients were randomly assigned to either the PCM‐7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 500 mg bid) or the PCM‐14 m group (modified 14 day therapy of the same regimen with metronidazole only given for 10 days due to labeling reasons). H. pylori status was determined by urease test, histology, culture, and 13 C‐urea breath test. Treatment outcome was assessed 6 weeks after intake of the last study medication. Results. The following eradication rates were achieved: for PCM‐7 in the MITT 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 symptoms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patients reported adverse events. Five serious adverse events occurred, all unrelated to the study medication. Conclusion. The two pantoprazole‐based triple therapies tested in this study are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generally sufficient.