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 < 0.0001); duodenal ulcers in 10 (1.1%) patients compared with 23 (5.1%; p < 0.0001); and at least one gastric or duodenal ulcer in 102 (11.0%) patients compared with 99 (21.9%; p < 0.0001). The cumulative incidence of gastro-duodenal ulcers was also lower in the HZT-501 group, as shown in figure 1. Also, fewer patients developed ulcers while taking low-dose aspirin or other anti-thrombotic agents with HZT-501 than those taking such agents with ibuprofen.

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Figure 1

The cumulative incidence of gastro-duodenal ulcers in patients receiving HZT-501(ibuprofen plus famotidine) or ibuprofen alone.

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.