Comparative Study of Modified-Release Clarithromycin and Immediate- Release Clarithromycin in the Treatment of Helicobacter Pylori-Associated Peptic Ulcer Disease

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 immediate release 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 ( AEC(MR)) or immediate-release clarithromycin 500mg twice daily (AEC(IR)) 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 C-13 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 AEC(MR) and AEC(IR), respectively, in the intent-to-treat analysis. Eradication rates in the per- protocol groups were 90.3% and 91.4% for AEC (MR) and AEC(IR) , respectively. In both the intent-to-treat and per- protocol analyses, the eradication rates were comparable in the AEC( MR) and AEC(IR) groups (p=1.0 and 1.0, respectively). Ulcer healing rates in the intention-to-treat analysis were 81.3% and 77.8% for AEC(MR) and AEC( IR), respectively. Ulcer healing rates in the per-protocol analysis were 90.3% and 90 .0% for AEC(MR) and AEC(IR) groups, respectively. In both the intention-to-treat and per-protocol analyses, the ulcer healing rates were comparable in the AEC(MR) and AEC(IR) 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