Adis Drug Evaluation

Clinical Drug Investigation

, Volume 33, Issue 9, pp 689-697

First online:

Fixed-Dose Ibuprofen/Famotidine: A Review of Its Use to Reduce the Risk of Gastric and Duodenal Ulcers in Patients Requiring NSAID Therapy

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A fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H2 receptor antagonist famotidine (ibuprofen/famotidine; DUEXIS®) is now available for the symptomatic treatment of arthritic symptoms and to reduce the risk of upper gastrointestinal (GI) ulcers in patients who require ibuprofen therapy. The gastroprotective efficacy of oral ibuprofen/famotidine 800/26.6 mg three times daily in patients requiring NSAID therapy for inflammatory conditions and/or pain was evaluated in two 24-week, well-designed trials (REDUCE-1 and -2). According to the post-adjudication analysis of these studies, ibuprofen/famotidine significantly reduced the life table estimated rate of gastric ulcers (primary endpoint of REDUCE-1) but not upper GI ulcers (i.e. gastric or duodenal ulcers) [primary endpoint of REDUCE-2] compared with ibuprofen alone. When life table estimated rates of secondary endpoints were assessed, significantly fewer recipients of the fixed-dose combination than of ibuprofen alone developed upper GI ulcers or duodenal ulcers in REDUCE-1, whereas the between-group difference in gastric ulcers and duodenal ulcers was considered to be nonsignificant in REDUCE-2 because of hierarchical testing. However, in a prespecified pooled analysis of REDUCE-1 and -2, the rate of upper GI ulcers as well as each of the upper GI ulcer components was significantly lower with ibuprofen/famotidine than with ibuprofen. Ibuprofen/famotidine was generally well tolerated, with a tolerability profile consistent with those established for the individual agents.