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 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 13C-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.


CONCLUSIONS
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.
Dammann
H G
HG
Clinical Research Hamburg, Wissenschafliches Institut, Hamburg, Germany.
Fölsch
U R
UR
Hahn
E G
EG
von Kleist
D H
DH
Klör
H U
HU
Kirchner
T
T
Strobel
S
S
Kist
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001991:Bronchitis / Q000139:chemically induced; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004064:Digestive System / Q000187:drug effects / Q000473:pathology; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005756:Gastritis / Q000188:drug therapy / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D010349:Patient Compliance; D013454:Sulfoxides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D013454:Sulfoxides; D008795:Metronidazole; D000077402:Pantoprazole; D017291:Clarithromycin; D009853:Omeprazole