• Haralampos Milionis, Fotios Barkas, George Ntaios, Vasileios Papavasileiou, Kostantinos Vemmos, Patrick Michel, and Moses Elisaf.
• Department of Internal Medicine, School of Medicine, University of Ioannina, Ioannina, Greece. Electronic address: hmilioni@uoi.gr.
• Eur. J. Intern. Med. 2016 Oct 1; 34: 54-57.

Background/PurposeA 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. We aimed to investigate the effect PCSK9 inhibition on stroke risk in a meta-analysis involving data from randomized studies with alirocumab and evolocumab.MethodsData 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.ResultsThe 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.ConclusionAlthough 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.Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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