Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses

Abstract

Non-steroidal anti-inflammatory drugs (NSAIDs), such as non-selective NSAIDs (nsNSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors, are commonly prescribed for arthritic pain relief in patients with osteoarthritis (OA), rheumatoid arthritis (RA), or ankylosing spondylitis (AS). Treatment guidelines for chronic NSAID therapy include the consideration for gastroprotection for those at risk of gastric ulcers (GUs) associated with the chronic NSAID therapy. The United States Food and Drug Administration has approved naproxen/esomeprazole magnesium tablets for the relief of signs and symptoms of OA, RA, and AS, and to decrease the risk of developing GUs in patients at risk of developing NSAID-associated GUs. The European Medical Association has approved this therapy for the symptomatic treatment of OA, RA, and AS in patients who are at risk of developing NSAID-associated GUs and/or duodenal ulcers, for whom treatment with lower doses of naproxen or other NSAIDs is not considered sufficient. Naproxen/esomeprazole magnesium tablets have been compared with naproxen and celecoxib for these indications in head-to-head trials. This systematic literature review and network meta-analyses of data from randomized controlled trials was performed to compare naproxen/esomeprazole magnesium tablets with a number of additional relevant comparators. For this study, an original review examined MEDLINE®, Embase®, and the Cochrane Controlled Trials Register from database start to April 14, 2009. Using the same methodology, a review update was conducted to December 21, 2009. The systematic review and network analyses showed naproxen/esomeprazole magnesium tablets have an improved upper gastrointestinal tolerability profile (dyspepsia and gastric or gastroduodenal ulcers) over several active comparators (naproxen, ibuprofen, diclofenac, ketoprofen, etoricoxib, and fixed-dose diclofenac sodium plus misoprostol), and are equally effective as all active comparators in treating arthritic symptoms in patients with OA, RA, and AS. Naproxen/esomeprazole magnesium tablets are therefore a valuable option for treating arthritic symptoms in eligible patients with OA, RA, and AS.

A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis

“…Patients taking naproxen/esomeprazole magnesium had less upper gastrointestinal complaints compared to those treated with naproxen only [29]. A meta-analysis showed that there was no difference in dyspepsia when comparing naproxen/esomeprazole magnesium with celecoxib as well as with PPI [10]. Based on these data, naproxen/esomeprazole magnesium has been approved for use in Europe.…”

“…This combination formulation demonstrated comparable analgesic efficacy in the treatment of osteoarthritis over a 3-month period [9]. There was no difference in dyspepsia compared to selective COX-2 inhibitors [10], and the incidence of endoscopic gastric ulcers in patients at risk of NSAID-associated ulceration was significantly reduced over a 6-month observation period [11]. In patients at risk of upper gastrointestinal complications who required NSAID therapy, treatment for more than one year with this combination formulation was not associated with any safety issues or adverse effects in the upper gastrointestinal tract or the cardiovascular system [12].…”

Anticancer Effects of Helminthostachys zeylanica Ethyl acetate Extracts on Human Gastric Cancer Cells through Downregulation of the TNF-α-activated COX-2-cPLA2-PGE2 Pathway

“…Because COX-2-specific inhibitors cannot block the production of systemic prostacyclin or inhibit thromboxane A2, these drugs may alter the balance between prothrombotic and antithrombotic activities in vivo , which may increase the risk of adverse cardiovascular events such as myocardial infarction. The European Union is amending the labeling instructions for anti-inflammatory COX-2 inhibitor drugs to strengthen the warning that these drugs can cause gastrointestinal and increase cardiovascular risk 76 - 78 .…”

Predictive value of gastrointestinal symptoms and patient risk factors for NSAID-associated gastrointestinal ulcers defined by endoscopy? Insights from a pooled analysis of two naproxen clinical trials

“…The fixed-dose combination of EC naproxen and esomeprazole has been shown to provide effective pain relief in patients with osteoarthritis [40,41]. It also significantly reduced the incidence of dyspepsia and gastric or gastroduodenal ulcers, regardless of low-dose aspirin use, compared to naproxen and other NSAIDs [29,[40][41][42][43][44][45] with an established long-term safety profile [46].…”