Eradication of Helicobacter pylori by 7-day triple-therapy regimens combining pantoprazole with clarithromycin, metronidazole, or amoxicillin in patients with peptic ulcer disease: results of two double-blind, randomized studies.

Abstract

AIM:

To compare the short-term (7-day) safety and efficacy of two triple-therapy regimens using pantoprazole with those of two dual-therapy regimens (one with pantoprazole and one without), for Helicobacter pylori eradication in patients with peptic ulcer disease.

METHODS:

H. pylori infection was identified by rapid urease (CLOtest), and confirmed by histology and culture. Patients were enrolled into one of two randomized, double-blind, multicenter, parallel-group studies. In study A, patients received oral pantoprazole 40 mg, clarithromycin 500 mg, and metronidazole 500 mg (PCM); pantoprazole, clarithromycin and amoxicillin 1000 mg (PCA); or pantoprazole and clarithromycin (PC). In study B, patients received PCM, PCA, PC, or clarithromycin and metronidazole without pantoprazole (CM). Treatments were given twice daily for 7 days. H. pylori status after therapy was assessed by histology and culture at 4 weeks after completing the course of study treatment. Modified intent-to-treat (MITT; each study: n = 424, n = 512) and per-protocol (PP; each study: n = 371, n = 454) populations were analyzed. The MITT population comprised all patients whose positive H. pylori status was confirmed by culture and histology; the PP population comprised patients who also complied with > or = 85% of study medication doses.

RESULTS:

A total of 1016 patients were enrolled. Cure rates among patients with clarithromycin-susceptible H. pylori strains were 82 and 86% for PCM, and 72 and 71% for PCA, in studies A and B, respectively. Cure rates among patients with metronidazole-susceptible H. pylori strains were 82 and 87% for PCM, and 71 and 69% for PCA, in studies A and B, respectively. The combined eradication rates observed with the PCM regimen were superior to those of all other regimens tested. Side-effects were infrequent and mild.

CONCLUSIONS:

PCM had the highest overall eradication rate in these two studies examining 7-day treatment regimens. All regimens were safe and well tolerated.

• Authors: Wieslaw J Bochenek, Suzanne Peters, Polly D Fraga, Wenjin Wang, Michael E Mack, Michael S Osato, Hala M T El-Zimaity, Kelly D Davis, David Y Graham, Helicobacter pylori Pantoprazole Eradication (HELPPE) Study Group
• Journal: Helicobacter (Helicobacter) Vol. 8 Issue 6 Pg. 626-42 (Dec 2003) ISSN: 1083-4389 [Print] England
• PMID: 14632678 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Anti-Bacterial Agents
• Anti-Infective Agents
• Anti-Ulcer Agents
• Benzimidazoles
• Sulfoxides
• Metronidazole
• Amoxicillin
• Pantoprazole
• Clarithromycin
• Omeprazole

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Amoxicillin (administration & dosage, adverse effects)
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Anti-Infective Agents (administration & dosage, adverse effects)
• Anti-Ulcer Agents (administration & dosage, adverse effects)
• Benzimidazoles (administration & dosage, adverse effects)
• Clarithromycin (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Resistance
• Drug Therapy, Combination
• Female
• Helicobacter Infections (drug therapy)
• Helicobacter pylori
• Humans
• Male
• Metronidazole (administration & dosage, adverse effects)
• Middle Aged
• Omeprazole (analogs & derivatives)
• Pantoprazole
• Peptic Ulcer (drug therapy, microbiology)
• Sulfoxides (administration & dosage, adverse effects)
• Treatment Outcome