Diclofenac
In a departure from the NICE guidance, which does not differentiate explicitly between different tNSAIDs, the consensus statement explicitly recommends against the use of diclofenac. The decision for this additional recommendation was based on the strength of emerging evidence (largely published after the development of the NICE guidance) suggesting a higher cardiovascular risk such as stroke, cardiovascular death and myocardial infarction with diclofenac than other tNSAIDs and selective COX-2 inhibitors [
8,
22,
23]. This emerging evidence suggests that it is prudent to take a precautionary approach and recommend the choice of one of the several alternative treatments to diclofenac when appropriate for new patients.
A retrospective population-based nested case-control analysis of data from the clinical records of more than 7 million patients registered with 468 UK general practices found a 55% increased risk of MI for those taking diclofenac, compared to those taking no tNSAIDs or COX-2 inhibitors in the previous 3 years (
p < 0.05) [
22]. The increased risk for ibuprofen was 24% and for the now withdrawn selective COX-2 inhibitor rofecoxib was 32% (both
p < 0.05) [
22]. For diclofenac the number needed to harm over a year was 521 treated patients for every additional myocardial infarction, compared to 1,005 for ibuprofen and 695 for rofecoxib. An observational study found a 5.54-fold increase in the risk of death and a 2.24-fold increase in the risk of admission to hospital with myocardial infarction in heart failure patients taking > 100 mg a day of diclofenac [
23]. In a recent study of a population of patients who had already had a myocardial infarction, diclofenac was identified as the tNSAID with the highest risk of death or recurrent MI (HR3.26; 95%CI2.57-3.86) - about twice the risk of treatment with any tNSAID (HR1.45;95%CI1.29-1.62) [
24].
Hm,, fun stuff.