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PCSK9 inhibitors to treat hypercholesterolemia: no effect on stroke risk

A reduction of cardiovascular events has been reported in phase 2 and 3 trials of the proprotein convertase subtilisin kexin 9 ( PCSK9 ) inhibitors Alirocumab and Evolocumab.

Researchers have investigated the effect PCSK9 inhibition on stroke risk in a meta-analysis involving data from randomized studies with Alirocumab and Evolocumab.

Data from pre-specified combined analysis of 4465 patients who completed phase 2 or 3 studies of Evolocumab over a period of 1year and a randomized trial on Alirocumab including 2341 patients with hyperlipidemia on maximally tolerated statin who were at high risk for coronary heart disease over a period of 1.5years were used.

The number of patients having an ischemic stroke was small in both trials.

PCSK9 inhibition showed no significant effect on stroke rate ( risk ratio 1.43; 95% CI, 0.45-4.57, p=0.55 ).

No significant differences in stroke risk were evident when transient ischemic attacks were included in the analysis ( risk ratio 0.65; 95% CI, 0.25-1.68, p=0.37 ).

No hemorrhagic strokes were reported in either study.

Although a benefit towards reduction of cardiovascular events in the overall has been documented, longer exposure is warranted to be able to evaluate the effect on stroke risk. ( Xagena )

Milionis H et al, Eur J Intern Med 2016; Epub ahead of print