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Predicting the Overuse of PCSK-9 Inhibitors

Rene Rodriguez-Gutierrez, MD1,2; Nilay D. Shah, PhD1,3; Victor M. Montori, MD, MSc1,2
[+] Author Affiliations
1Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota
2Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Medicine, Mayo Clinic, Rochester, Minnesota
3Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
JAMA. 2015;314(18):1909-1910. doi:10.1001/jama.2015.13414.
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This Viewpoint anticipates widespread premature use of proprotein convertase subtilisin-kexin type 9 (PCSK-9) inhibitors in response to the challenges some patients experience taking statins and urges caution until trials and experience demonstrate the new drugs are safe.

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.

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