Comparative efficacy and safety of nimesulide and diclofenac in patients with acute shoulder, and a meta-analysis of controlled studies with nimesulide.

Adverse events, particularly gastrointestinal, partially offset the therapeutic value of NSAIDs. The abilities of nimesulide to inhibit COX-2 preferentially and to exert other novel anti-inflammatory actions are consistent with good efficacy and safety. This is borne out by a double-blind multicentre comparison of nimesulide and diclofenac in 122 patients with acute shoulder, and by a meta-analysis of various nimesulide trials. At the end of the 14 day double-blind study, nimesulide was at least as effective as diclofenac (investigator ratings: good/very good in 79.0% of patients given nimesulide, and 78.0% with diclofenac; patient ratings: good/very good in 82.3 and 78.0% respectively). Four patients (6.5%) dropped out in the nimesulide group (two early recovery, one lack of effect, one adverse event), compared with 13 (21.7%) in the diclofenac group, due mainly to adverse events (P=0.003). Global tolerability was judged by the investigators to be good/very good in 96.8% of the nimesulide group compared with 72.9% of those given diclofenac. Judgements by the patients were 96.8 and 78.0% respectively. Both differences are highly significant statistically. The meta-analysis demonstrates that nimesulide given for 2 weeks is far more efficacious than placebo in treating osteoarthritis, and is at least comparable to other NSAIDs The benefit-risk ratio for nimesulide was better in all individual studies since 100 mg nimesulide twice daily was about equal to placebo in safety and tolerability, especially regarding gastrointestinal adverse events.