Reducing the incidence of peptic ulcers with ibuprofen-famotidine combined pill, HZT-501 (reduce): phase-III, double-blind multi-centre trials

Abstract

Introduction The prevention of peptic ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs) is hampered by the high pill burden and suboptimal adherence to protective therapy. We therefore investigated the efficacy of HZT-501 (ibuprofen 800-mg plus famotidine-26.6 mg) in the prevention of peptic ulcers in patients requiring NSAIDs. Methods Patients without ulcers at baseline were randomly assigned, in approximately a 2:1 ratio, to receive HZT-501 or ibuprofen 800-mg three times daily and entered into two multi-centre trials (REDUCE-1 and REDUCE-2) with identical designs. They were re-endoscoped at 8, 16 and 24 weeks. The primary endpoints were the development of new ulcers during 24 weeks. The data from the two trials were pooled and analysed using a primary population analysis. Results At 24 weeks, comparing patients assigned to HZT-501 with patients assigned to ibuprofen, gastric ulcers had developed in 92 (9.9%) of 930 patients compared with 86 (19.0%) of 452 patients (p Conclusion Ibuprofen combined with famotidine (HZT-501) results in fewer peptic ulcers regardless of aspirin use. This might improve adherence to mucosal protective therapy in NSAID users.