Comparative study of modified-release clarithromycin and immediate-release clarithromycin in the treatment of Helicobacter pylori-associated peptic ulcer disease
Liou, J-Ming.; Chen, C-Yi.; Wu, M-Shiang.; Hsu, M-Tse.; Fang, C-Chung.; Lin, Y-Ling.; Chang, M-Chu.; Lin, J-Town.; Wang, H-Po.
Hepato-Gastroenterology 53(71): 792-796
2006
ISSN/ISBN: 0172-6390 PMID: 17086891 Document Number: 2177
Background/Aims: Proton pump inhibitor-based triple therapy containing immediate-release clarithromycin is an important regimen for the eradication of Helicobacter pylori (H. pylori). However, the efficacy of modified-release clarithromycin for the treatment of H. pylori-associated peptic ulcer disease is still unknown. The aims of the study were to compare the efficacy of modified-release clarithromycin and immediaterelease clarithromycin on the rates of ulcer healing and eradication of H. pylori. Methodology: One hundred and sixty-one patients with Helicobacter pylori-associated peptic ulcer were randomized to receive one-week triple therapy with either modified-release clarithromycin 1000mg once daily (AECMR) or immediate-release clarithromycin 500mg twice daily (AECIR) in combination with amoxicillin 1,000mg twice daily (A) and esomeprazole 40mg once daily (E). Post-treatment ulcer healing status and Helicobacter pylori status was determined by endoscopy and 1-3C urea-breath test at 16 weeks and 8 weeks after completion of triple therapy, respectively. Results: Helicobacter pylori eradication rates were 87.5% and 87.7% for AECMR and AECIR, respectively, in the intent-to-treat analysis. Eradication rates in the per-protocol groups were 90.3% and 91.4% for AECMR and AECIR, respectively. In both the intenttotreat and per-protocol analyses, the eradication rates were comparable in the AECMR and AECIR groups (p=1.0 and 1.0, respectively). Ulcer healing rates in the intention-to-treat analysis were 81.3% and 77.8% for AECMR and AECIR, respectively. Ulcer healing rates in the per-protocol analysis were 90.3% and 90.0% for AECMR and AECIR groups, respectively. In both the intention-to-treat and per-protocol analyses, the ulcer healing rates were comparable in the AECMR and AECIR groups (p=0.645 and 0.584, respectively). Conclusions: Modified-release clarithromycin 1000mg once daily can be used as an alternative to immediate-release clarithromycin 500mg twice daily for the treatment of Helicobacter pylori-associated peptic ulcer disease.
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