Nimesulide -- a multifactorial approach to inflammation and pain: scientific and clinical consensus.

BACKGROUND This paper summarises the outcome from a consensus meeting, held in Rome on 5 October 2005, that aimed to review the state of the art regarding the non-steroidal anti-inflammatory drug (NSAID) nimesulide, with reference to its chemical, pharmacokinetic, pharmacological and clinical characteristics. SCOPE The meeting aimed to provide a continuous and up-to-date evaluation of the clinical and safety profile of nimesulide, and of its role in the treatment of inflammatory pain, in light of existing therapeutic alternatives, through a revision and critical discussion on the information available on the drug among authoritative experts in different fields of medical science. FINDINGS The members of the Consensus Report Group on Nimesulide (CRGN) recognised that nimesulide is an NSAID which exerts its analgesic, anti-inflammatory and antipyretic activities thanks to unique chemical and pharmacokinetic characteristics, and to a multifactorial mechanism of action, which goes beyond its preferential inhibitory activity on the COX-2 enzyme. Nimesulide was found to be at least as effective, or superior, to placebo and other NSAIDs, with a particularly fast onset of analgesic action. The safety profile is in line with that expected from the class, with evidence of a better gastrointestinal safety profile. CONCLUSIONS Based on the available evidence, the CRGN concluded that nimesulide remains an effective and safe therapeutic choice for the treatment of various painful inflammatory conditions, with a rapid onset of analgesic activity and an overall positive benefit/risk profile.