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Comment & Response
October 2017

PCSK9 Inhibitors, Statins, Low-Density Lipoprotein Cholesterol, Mevalonate Pathway, and Toxicity—Reply

Author Affiliations
  • 1Jacksonville Center for Clinical Research, Jacksonville, Florida
  • 2Brigham and Women’s Hospital, Cardiovascular Division/TIMI Study Group, Boston, Massachusetts
JAMA Cardiol. 2017;2(10):1169. doi:10.1001/jamacardio.2017.2734

In Reply We appreciate Guijarro’s interest in our article.1 We agree with Guijarro that there are important differences in the mechanism of action between statins and proprotein convertase subtilisin/kexin type 9 inhibitors. Evolocumab has now demonstrated a favorable safety and tolerability profile during extended long-term open-label observation (the OSLER trial1) and in a large randomized, placebo-controlled clinical trial (the FOURIER trial2). Importantly, in the FOURIER trial, the safety analyses compared evolocumab with placebo, not lower vs higher levels of LDL, and found no safety imbalances other than a slight increase in injection site reactions in the evolocumab group.2 We would also add that extensive randomized clinical trial data show that statins are a safe therapeutic class.

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