Outcomes benefits were present, although somewhat less than anticipated, setting the stage for pricing debates and real-world monitoring of evolocumab's use.
Prior research on evolocumab — a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) — has shown that this now FDA-approved drug can reduce LDL-cholesterol levels by 50% to 60% (NEJM JW Cardiol Jun 2014 and N Engl J Med 2014; 370:1811). We now have data from FOURIER, a manufacturer-funded outcomes trial of the drug (NCT01764633).
Researchers randomized 27,564 statin-treated patients with atherosclerotic cardiovascular disease (CVD) and LDL levels ≥70 mg/dL (median, 92 mg/dL) to receive subcutaneous evolocumab (140 mg every 2 weeks or 420 mg every month, as the patient preferred) or matching placebo. By 48 weeks of treatment, the drug had reduced LDL levels by 59%, compared with placebo, to a median of 30 m…
Reviewing Author
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association