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Reducing the incidence of peptic ulcers with ibuprofen-famotidine combined pill, HZT-501 (reduce): phase-III, double-blind multi-centre trials
  1. A S Taha *1,
  2. L A Laine2,
  3. A Grahn3
  1. 1Medicine, University of Glasgow/ Crosshouse Hospital, Kilmarnock, UK
  2. 2Medicine, University of Southern California School of Medicine, Los Angeles, USA
  3. 3Medicine, Horizon Therapeutics, Chicago, USA

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 < 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.

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.

  • aspirin
  • duodenal ulcer
  • famotidine
  • gastric ulcer
  • ibuprofen
  • NSAIDs.

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Footnotes

  • Competing interests A. Taha Consultant for: Membership of Advisory Panel for Horizon Pharma, L. Laine Consultant for: Membership of Advisory Panel for Horizon Pharma, A. Grahn Conflict with: Employee of Horizon Pharma.

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