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NPC Rapid Review New evidence for naproxen/esomeprazole� combination in knee osteoarthritis. Rapid reviews | Podcasts | Shared practice examples | Events | Publications and resources | FAQs | Email alerts | Newsroom | Contact us | A to Z a fixed-dose combination of naproxen and esomeprazole (Vimovo�) had comparable upper gastrointestinal (GI) tolerability to celecoxib in people with osteoarthritis (OA) of the knee. However, there are no data to suggest that this fixed-dose combination offers any efficacy or safety advantages over the separate prescribing of naproxen 1000 mg daily plus a low-cost proton pump inhibitor (PPI) such as generic omeprazole. Separate prescribing allows for dose adjustment of individual components and is less expensive. Although coxibs (e.g. celecoxib) are associated with a lower risk of GI adverse effects than traditional NSAIDs when used without a PPI, there is no good evidence to suggest there are any differences in the GI risk of NSAIDs (coxibs or traditional NSAIDs) when prescribed with a PPI as per NICE guidance. Coxibs (and some traditional NSAIDs, particularly diclofenac) also have a higher CV risk than either ibuprofen (1200 mg daily or less) or naproxen 1000 mg daily. Therefore, prescribers should carefully consider the other potential side effects, particularly CV risks, when choosing an NSAID, taking account of individual patient risk factors. Generally, NSAIDs should be prescribed at the lowest effective dose and for the shortest period of time necessary to control symptoms, and reviewed regularly. Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links [UPDATE 12/11/2007] FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the "Update of Safety Review" for information regarding the two studies that were reviewed.Esomeprazole: a clinical review Skip to main page content Esomeprazole: a clinical review TJ Johnson and DD Hedge The pharmacology, pharmacodynamics, pharmacokinetics, clinical efficacy, and adverse effects of esomeprazole are reviewed. Esomeprazole, a proton-pump inhibitor (PPI), is the S-isomer of omeprazole. Esomeprazole has FDA-approved labeling for use in the treatment of symptomatic gastroesophageal reflux disease (GERD), including healing and maintenance of healing of erosive esophagitis and as part of a triple-drug regimen for Helicobocter pylori infection. Esomeprazole is structurally similar to other PPIs but is the first PPI to include only the active isomer, which may lead to improved pharmacokinetic and pharmacodynamic characteristics. Esomeprazole maintains intragastric pH at a higher level and above 4 for a longer period than other PPIs.
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