OBJECTIVE:
To conduct a systematic review of evidence supporting the efficacy and safety profiles of nonsteroidal anti-inflammatory drugs (NSAIDs) introduced in the last decade for the treatment of patients with osteoarthritis (OA), including their analgesic effects, ability to improve function, and adverse event profiles relative to current standards of care.

RESEARCH DESIGN AND METHODS:
Systematic search of the literature for NSAIDs approved by the FDA (2000-2010).

RESULTS:
One new orally-administered NSAID molecule (meloxicam), two orally-administered NSAID formulations (naproxen plus lansoprazole; oxycodone/ibuprofen), and three topical NSAID formulations (diclofenac patch, gel, and solution) were approved by the FDA (2000-2010). A systematic literature review found evidence to support efficacy in treating patients with OA for all agents except oxycodone/ibuprofen, which has not been studied in this patient population, although ibuprofen and immediate-release oxycodone have been studied individually for OA pain. Evidence quality was inconsistent, with several agents lacking long-term, controlled trials against active comparators, and functional end points inconsistently met. Although low-dose meloxicam and naproxen plus lansoprazole offer a reduced risk of adverse gastrointestinal (GI) events, cardiovascular and renal risks remain similar to traditional oral NSAID therapy. Further, only lower doses of meloxicam appear to carry a reduced risk of GI events. Diclofenac patch, gel, and solution preparations offer the potential for reduced GI, cardiovascular, and renal adverse events. The level of evidence available to support the efficacy and safety of these agents for long-term treatment of patients with OA differs, with some having only short-term trials, while others have longer-duration trials with active comparators.

CONCLUSIONS:
By expanding the treatment armamentarium, newly-approved NSAID agents may improve the ability of clinicians to tailor analgesic therapy for their diverse patient populations and to achieve realistic functional improvements. The comparisons in this article were limited to drugs that received approval after 2000 and should be considered accordingly.





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