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A randomized double-blind multicentre phase III trial was conducted to compare the tolerability and efficacy of nimesulide and diclofenac in patients having acute shoulder pain. A meta-analysis of nimesulide clinical trials comparing nimesulide and diclofenac was also carried out.
In
patients with acute shoulder pain, nimesulide has a favourable benefit-risk
ratio (reduced gastrointestinal adverse events). Nimesulide displayed superior
efficacy and equal safety compared to placebo. Compared to other NSAIDS,
nimesulide was found to be at least as efficacious but superior in terms of
safety and tolerance.
A
randomized double-blind multicentre phase III trial was conducted to compare
the tolerability and efficacy of nimesulide
and diclofenac in patients having acute shoulder pain. A meta-analysis
of nimesulide clinical trials comparing nimesulide and diclofenac was also
carried out.
The
study recruited 122 adult patients suffering from acute shoulder pain. The
patients were randomly allocated to either nimesulide group (100 mg twice
daily, n=62) or diclofenac (75 mg twice daily, n=60) group. Participants were
followed for two weeks. At the end of the study, a global judgement of
tolerability was given by patients and investigators. The benefit-risk ratio
was estimated from the global judgements of tolerability and efficacy.
At the end of the study, nimesulide displayed at least comparable efficacy to diclofenac. A greater number of patients dropped out in the diclofenac cohort (due to the occurrence of adverse events) compared to the nimesulide cohort (two early recovery, one adverse event, one lack of effect). The global tolerability was judged by the investigators and the patients to be good/very good in patients receiving nimesulide compared to patients receiving diclofenac, as shown in the below table:
The meta-analysis illustrated that
compared to placebo, nimesulide given for two weeks is highly efficacious in
managing osteoarthritis, and is at least similar to other non-steroidal
anti-inflammatory drugs (NSAIDs).
In all the individual studies, the
benefit-risk ratio for nimesulide was found to be better since 100 mg
nimesulide twice daily demonstrated equal safety and tolerability in comparison
with placebo, specifically the gastrointestinal adverse events.
Rheumatology
Comparative efficacy and safety of nimesulide and diclofenac in patients with acute shoulder, and a meta-analysis of controlled studies with nimesulide
W Wober
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