Article

Discussions about statin efficacy in cardiovascular prevention are
always based on data from blinded randomized controlled trials (RCTs) comparing
statin to placebo; however, discussion of side effects is not. Clinicians often
assume symptoms occurring with statins are caused by statins, encouraging
discontinuation. We test this assumption and calculate an evidence-based estimate
of the probability of a symptom being genuinely attributable to the statin
itself. METHODS: We identified RCTs comparing statin to placebo for
cardiovascular prevention that reported side effects separately in the two arms.
RESULTS: Among 14 primary prevention trials (46,262 participants), statin therapy
increased diabetes by absolute risk of 0.5% (95% CI 0.1-1%, p = 0.012), meanwhile
reducing death by a similar extent: -0.5% (-0.9 to -0.2%, p = 0.003). In the 15
secondary prevention RCTs (37,618 participants), statins decreased death by 1.4%
(-2.1 to -0.7%, p < 0.001). There were no other statin-attributable symptoms,
although asymptomatic liver transaminase elevation was 0.4% more frequent with
statins across all trials. Serious adverse events and withdrawals were similar in
both arms. CONCLUSIONS: Only a small minority of symptoms reported on statins are
genuinely due to the statins: almost all would occur just as frequently on
placebo. Only development of new-onset diabetes mellitus was significantly higher
on statins than placebo; nevertheless only 1 in 5 of new cases were actually
caused by statins. Higher statin doses produce a detectable effect, but even
still the proportion attributable to statins is variable: for asymptomatic liver
enzyme elevation, the majority are attributable to the higher dose; in contrast for muscle aches, the majority are not.
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Langue : ANGLAIS