Fixed-dose naproxen/esomeprazole magnesium: a guide to its use to treat arthritic symptoms and reduce gastric ulcer risk
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Fixed-dose naproxen/esomeprazole magnesium: a guide to its use to treat arthritic symptoms and reduce gastric ulcer risk Katherine A. Lyseng-Williamson, and Sohita Dhillon Adis, Auckland, New Zealand
Oral naproxen/esomeprazole magnesium (Vimovo) is a fixed-dose combination of an NSAID and a proton pump inhibitor. The combination is indicated to provide relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing NSAID-associated gastric ulcers (US), and in patients who are at risk of developing NSAID-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient (EU).
What is the rationale for developing the fixed-dose combination? NSAIDs are commonly used for the treatment of pain and inflammation in chronic conditions, such as rheumatoid arthritis and osteoarthritis.[1] However, these agents are often associated with gastrointestinal adverse events, such as peptic ulcer disease and its complications. Risk factors associated with an increased risk of NSAID-related gastrointestinal injury include advanced patient age, co-morbidities and the use of concurrent medications.[1,2] The risk of injury in older patients is further compounded by the frequent use of lowdose aspirin (acetylsalicylic acid) for antithrombotic prophylaxis, and long-term NSAID therapy for chronic inflammatory conditions.[2] The pathogenesis of NSAID-related ulcers is complex and multifactorial,[3] involving primarily systemic effects.[4] Although cyclo-oxygenase [COX]-2-selective NSAIDs are associated with a lower incidence of gastrointestinal adverse events than nonselective NSAIDs, ulcers and their complications may still occur. There are also concerns regarding the cardiovascular safety of NSAIDs.[1] Therefore, co-therapy with agents that prevent and/or heal NSAID-related
mucosal damage (e.g. proton pump inhibitors [PPIs], highdose histamine H2 receptor antagonists or misoprostol) is recommended in patients at risk of developing gastrointestinal complications.[1,5] However, co-therapy for the prevention of NSAID-related gastrointestinal adverse events is often underprescribed,[6] and patients do not adhere to such treatment over time.[7] An oral, single-tablet, fixed-dose combination of the NSAID naproxen and the PPI esomeprazole magnesium (Vimovo) has been developed to provide pain relief and reduce the risk of gastric ulcers.[8] It comprises an enteric-coated (EC) naproxen core surrounded by an immediate-release esomeprazole magnesium mantle, designed to provide sequential delivery of gastroprotective esomeprazole followed by the release of naproxen.[9,10]
How do the drugs work? Naproxen is an NSAID with anti-inflammatory, analgesic and antipyretic properties.[9,10] Its pharmacodynamic properties are thought to be related to the inhibition of prostaglandin synthesis via inhibition of COX-1 and COX-2 enzymes.[9,10] Esomeprazole (the S-isomer of omeprazole) is a PPI that inhibits the H+/K+-adeno
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