Concomitant versus sequential therapy for the treatment of Helicobacter pylori infection: a Greek randomized prospective study

• Published in: Scandinavian journal of gastroenterology 2016-02, Vol.51 (2), p.145-151
• Main Authors: Apostolopoulos, Periklis, Koumoutsos, Ioannis, Ekmektzoglou, Konstantinos, Dogantzis, Panagiotis, Vlachou, Erasmia, Kalantzis, Chrisostomos, Tsibouris, Panagiotis, Alexandrakis, Georgios
• Format: Article
• Language: English
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles - administration & dosage; Adult; Aged; Amoxicillin - administration & dosage; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - pharmacology; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - pharmacology; Breath Tests; Clarithromycin - administration & dosage; Clarithromycin - pharmacology; Concomitant; Drug Administration Schedule; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Female; Greece; Helicobacter Infections - drug therapy; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Intention to Treat Analysis; Male; Medication Adherence; Metronidazole - administration & dosage; Metronidazole - pharmacology; Middle Aged; Prospective Studies; Proton Pump Inhibitors - administration & dosage; sequential; Treatment Outcome
• ISSN: 0036-5521; 1502-7708
• DOI: 10.3109/00365521.2015.1079646

Objective: The objective of this study is to compare, in Greece, a region with >20% local resistance to clarithromycin, the efficacy rates of the concomitant versus the sequential H. pylori eradication therapy. Materials and methods: Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day concomitant or 10-day sequential therapy. Treatment outcome was assessed by C 13 -urea breath test at least 4 weeks after therapy. Intention to treat (ITT) and per protocol (PP) analysis of the eradication rates were performed. Secondary end points included patient compliance and safety. Results: The concomitant therapy group achieved statistically significant higher eradication rates when compared with the sequential treatment group, both in the ITT and in the PP analysis (84.6% versus 70.9%, p = 0.002, and 90.6% versus 78.1%, p = 0.001, respectively), after adjusting for age, gender, smoking status, and the presence or not of ulcer and/or non-ulcer dyspepsia. Both groups displayed excellent compliance rates (99.5% for the concomitant therapy group and 96.2% for the sequential therapy group, p = 0.067). Regarding treatment safety, major adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the two groups (7.0% for the concomitant therapy group and 2.9% for the sequential therapy group). Conclusions: Concomitant therapy led to statistically significant higher eradication rates over sequential therapy. Both therapies showed excellent compliance and an acceptable safety profile. The 10-day quadruple concomitant scheme should be the adopted for first-line H. pylori eradication in Greece.