Helicobacter pylori Eradication Therapy Success Regarding Different Treatment Period Based on Clarithromycin or Metronidazole Triple-Therapy Regimens

• Published in: Helicobacter (Cambridge, Mass.) Vol. 14; no. 1; pp. 29 - 35
• Main Authors: Filipec Kanizaj, Tajana, Katicic, Miroslava, Skurla, Bruno, Ticak, Mirjana, Plecko, Vanda, Kalenic, Smilja
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-02-2009
• Subjects: Adult; Aged; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Drug Administration Schedule; Drug Therapy, Combination; eradication therapy; Female; H. pylori; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Male; metronidazole; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; Treatment Outcome
• DOI: 10.1111/j.1523-5378.2009.00656.x
• EISSN: 1523-5378
• ISSN: 1083-4389

Background: The study compares the eradication success of standard first‐line triple therapies of different durations (7, 10, and 14 days).
Materials and Methods: A total of 592 naive Helicobacter pylori‐positive patients were randomized to receive pantoprazole, amoxicillin, and clarithromycin or metronidazole for 14 days (PACl14 or PAM14), 10 days (PACl10 or PAM10), or 7 days (PACl7 or PAM7). H. pylori eradication was assessed by histological, microbiological, and rapid urease examination.
Results: The intention‐to‐treat (ITT) and per‐protocol (PP) analyses have shown no overall statistically significant differences between the eradication success of PACl and PAM treatment groups (ITT p = .308, PP p = .167). Longer treatment duration has yielded statistically significant increase in eradication success for clarithromycin (ITT p = .004; PP p = .004) and metronidazole (ITT p = .010; PP p = .034) based regimens. Namely, PACl10, PACl14, and PAM14 protocols resulted in eradication success exceeding 80% in ITT and 90% in PP analysis. Primary resistance to clarithromycin and metronidazole equals 8.2% and 32.9%, respectively. Prolonging the metronidazole‐based treatment duration in patients with resistant strains resulted in statistically significant higher eradication success.
Conclusions: For all antimicrobial combinations, 14 days protocols have led to a significant increase of H. pylori eradication success when compared to 10 and 7 days, respectively. Prolonging the treatment duration can overcome the negative effect of metronidazole resistance. Only PAM14, PACl10 protocols achieved ITT success > 80% and should be recommended as the first line eradication treatment in Croatia.