JYH-MING LIOUChen C.-Y.MING-SHIANG WUHsu M.-T.Fang C.-C.Lin Y.-G.MING-CHU CHANGLin J.-T.HSIU-PO WANG2021-01-152021-01-1520060172-6390https://www.scopus.com/inward/record.uri?eid=2-s2.0-33750584350&partnerID=40&md5=28088720d536778806eafe56c1c9ae79https://scholars.lib.ntu.edu.tw/handle/123456789/541163Background/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 (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 13C 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 AEC IR, 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 intent-to-treat 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 AEUMH 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. ? H.G.E. Update Medical Publishing S.A.[SDGs]SDG3amoxicillin; clarithromycin; esomeprazole; adult; article; clinical trial; comparative study; controlled clinical trial; controlled study; demography; dose response; drug blood level; drug efficacy; drug formulation; drug release; eradication therapy; female; gastroscopy; Helicobacter pylori; human; male; peptic ulcer; priority journal; randomized controlled trial; ulcer healing; unspecified side effect; urea breath test; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Delayed-Action Preparations; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Peptic Ulcer; Proton Pumpsjournal article170868912-s2.0-33750584350