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In July and August of 2015, the US Food and Drug Administration (FDA) approved alirocumab and evolocumab for patients with familial hypercholesterolemia or with clinical atherosclerotic cardiovascular disease (CVD) who are seeking secondary prevention. These monoclonal antibodies inhibit proprotein convertase subtilisin-kexin type 9 (PCSK-9). In phase 3 randomized clinical trials, PCSK-9 inhibitors reduced levels of low-density lipoprotein cholesterol (LDL-C) by 50% to 70% when added to statins. To date, evidence warranting only low confidence in estimates of efficacy (because of very few events) suggests that the use of these agents may reduce the risk of CVD mortality by 50% (95% CI, −10% to 77%) and all-cause mortality by 55% (95% CI, 14% to 77%).1 Little is known about the long-term safety of these drugs.
Rodriguez-Gutierrez R, Shah ND, Montori VM. Predicting the Overuse of PCSK-9 Inhibitors. JAMA. 2015;314(18):1909-1910. doi:10.1001/jama.2015.13414