R J Hopkins1, L S Girardi, E A Turney. 1. Division of Anti-Infective Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Department of Health and Human Services, Rockville, Maryland, USA.
Abstract
BACKGROUND & AIMS: The aim of this study was to determine whether the current literature supports the use of Helicobacter pylori cure as the primary efficacy end point in peptic ulcer clinical trials. This could potentially reduce the complexity of future trials. METHODS: Published articles containing information on both H. pylori eradication and ulcer recurrence were searched with MEDLINE. Abstracts were found by reviewing references from both primary and review articles. RESULTS: Fourteen duodenal ulcer and five gastric ulcer studies satisfied requisite inclusion criteria. Ulcer recurrence was significantly less common among H. pylori-cured patients vs. noncured patients (6% vs. 67% for patients with duodenal ulcers; 4% vs. 59% for patients with gastric ulcers). For H. pylori-cured patients, duodenal ulcer recurrence was higher in studies using two endoscopic tests compared with three tests (9% vs. 3%) and higher in abstracts compared with published articles (14% vs. 4%). Timing of H. pylori eradication (4 weeks vs. < / = 12 weeks) and ulcer recurrence assessment (6 months vs. < / = 12 months) was not significantly related to duodenal ulcer recurrence. CONCLUSIONS: The current literature strongly suggests that H. pylori eradication 4 weeks after therapy should be used as the primary efficacy end point for reduced gastric and duodenal ulcer recurrence for the purpose of clinical trial design.
BACKGROUND & AIMS: The aim of this study was to determine whether the current literature supports the use of Helicobacter pylori cure as the primary efficacy end point in peptic ulcer clinical trials. This could potentially reduce the complexity of future trials. METHODS: Published articles containing information on both H. pylori eradication and ulcer recurrence were searched with MEDLINE. Abstracts were found by reviewing references from both primary and review articles. RESULTS: Fourteen duodenal ulcer and five gastric ulcer studies satisfied requisite inclusion criteria. Ulcer recurrence was significantly less common among H. pylori-cured patients vs. noncured patients (6% vs. 67% for patients with duodenal ulcers; 4% vs. 59% for patients with gastric ulcers). For H. pylori-cured patients, duodenal ulcer recurrence was higher in studies using two endoscopic tests compared with three tests (9% vs. 3%) and higher in abstracts compared with published articles (14% vs. 4%). Timing of H. pylori eradication (4 weeks vs. < / = 12 weeks) and ulcer recurrence assessment (6 months vs. < / = 12 months) was not significantly related to duodenal ulcer recurrence. CONCLUSIONS: The current literature strongly suggests that H. pylori eradication 4 weeks after therapy should be used as the primary efficacy end point for reduced gastric and duodenal ulcer recurrence for the purpose of clinical trial design.
Authors: Morris O Makobongo; Hanan Gancz; Beth M Carpenter; Dennis P McDaniel; D Scott Merrell Journal: Antimicrob Agents Chemother Date: 2011-11-07 Impact factor: 5.191