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

Abstract

327 IntroductionChronic pain conditions affect at least 116 million US adults and more than one-third of adults worldwide [IOM, 2011;Tsang et al. 2008]. Nonsteroidal anti-inflammatory drugs (NSAIDs) are a mainstay of therapy for many of these individuals [Herndon et al. 2008]. Worldwide, over 73,000,000 prescriptions for NSAIDS are written yearly [Biederman, 2005] Abstract: Chronic pain conditions affect at least 116 million US adults and more than onethird of adults worldwide. Nonsteroidal anti-inflammatory drugs (NSAIDs) are used extensively for the treatment of chronic pain due to their efficacy as anti-inflammatory and analgesic agents. Gastrointestinal toxicity is the most well known adverse effect of NSAID therapy and it may manifest as dyspepsia, ulcers, or bleeding. Current guidelines for the management of patients who require NSAIDs for chronic pain and inflammation recognize the potential toxicity associated with these drugs and the need for gastroprotection. 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. The combination of ibuprofen and famotidine in a single tablet has the potential to improve adherence to gastroprotective therapy in patients who require 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).

Use of NSAIDs in treating patients with arthritis

“…The combination of enteric-coated naproxen and the proton pump inhibitor esomeprazole (vimovo) was shown to reduce endoscopically detected gastric ulcers [ 20 ]. The combination of ibuprofen and the H 2 -blocker famotidine (duexis) was also shown to reduce endoscopically detected gastric and duodenal ulcers [ 21 ].…”

Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies

“…Lower-dose capsules that contain finely milled, rapidly absorbed NSAID particles may also provide analgesia at lower systemic doses. 80 , 81 Low-dose diclofenac capsules (18 mg or 35 mg TID for mild-to-moderate pain) and indomethacin capsules (20 mg TID or 40 mg two times daily or TID) containing fine-milled particles have been approved by the FDA for treatment of mild-to-moderate acute pain in adults 25 , 108 and have been found to provide effective relief of acute, postoperative pain in Phase III studies. 80 , 81 Additionally, low-dose diclofenac (35 mg TID) has been shown to provide effective treatment of OA pain in a 12-week study and has been approved by the FDA for management of OA-related pain.…”

Management of Osteoarthritis with Avocado/Soybean Unsaponifiables

“…To reduce the risk of these upper GI complications, the US FDA has approved the use of the NSAID HZT501 (Duexis), a drug containing 800 mg ibuprofen, in combination with 26.6 mg famotidine, a histamine H2-receptor antagonist. 14 Alternatively the NSAID celecoxib has less risk of upper GI complications by selectively inhibiting the isoenzyme COX-2, which is specific to inflamed tissue, versus COX-1, which is constitutive in many tissues including the GI tract. It should be noted that daily treatment with celecoxib is more effective in patients with normal body mass index (BMI) than obese patients.…”