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).Methods
- 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.