DUEXIS (ibuprofen 800 mg, famotidine 26.6 mg): a new approach to gastroprotection for patients with chronic pain and inflammation who require treatment with a nonsteroidal anti-inflammatory drug
Therapeutic Advances in Musculoskeletal Disease, 05/16/2012
Bello AE – The combination of ibuprofen and famotidine in a single tablet has the potential to improve adherence to gastroprotective therapy in patients who require Nonsteroidal anti–inflammatory drug (NSAID) treatment and the use of a histamine type 2 receptor antagonist rather than a proton–pump inhibitor may decrease the risk for clinically significant drug interactions and adverse events (e.g. interaction with clopidogrel, fracture, pneumonia, Clostridium difficile infection).
DUEXIS (ibuprofen 800 mg, famotidine 26.6 mg) is a proprietary combination, immediate release tablet containing 800 mg of ibuprofen and 26.6 mg of famotidine.
The efficacy of DUEXIS taken three times daily has been demonstrated in two large–scale controlled clinical trials (Registration Endoscopic Studies to Determine Ulcer Formation of HZT–501 Compared with Ibuprofen: Efficacy and Safety Studies (REDUCE) and REDUCE–2) which showed that this new formulation significantly reduced the risk of endoscopic upper gastrointestinal ulcers compared with ibuprofen alone (REDUCE–1, p < 0.0001, REDUCE–2, p <0.05).
DUEXIS was also superior to ibuprofen in decreasing the risk for gastric ulcers (REDUCE–1, p < 0.001, REDUCE–2, p < 0.05) as well as duodenal ulcers (REDUCE–1, p < 0.05, REDUCE–2, p < 0.05).
Safety results from these two studies indicated that treatment–emergent adverse events occurred in 55% of patients treated with DUEXIS versus 58.7% for ibuprofen, and serious adverse events were recorded for 3.2% of patients treated with DUEXIS versus 3.3% of those on ibuprofen.
Adverse events leading to discontinuation occurred in 6.7% of patients treated with DUEXIS and 7.6% for ibuprofen.
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