In Very-High-Risk Patients with Vascular Disease, Evolocumab Slightly Reduces Nonfatal MI but Not Mortality


Am Fam Physician. 2017 Oct 1;96(7):470.

Clinical Question

Does evolocumab (Repatha), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, reduce the likelihood of cardiovascular events in patients with cardiovascular disease who are already taking a statin?

Bottom Line

In an extremely high-risk group of patients with known vascular disease, taking evolocumab instead of placebo in addition to standard statin therapy for slightly more than two years will prevent one myocardial infarction (MI) for every 83 persons treated and prevent one stroke for every 250 persons treated. At the current cost of the drug in the United States, that amounts to approximately $2.5 million per nonfatal MI prevented. (Level of Evidence = 1b)


PCSK9 inhibitors lower low-density lipoprotein (LDL) cholesterol levels, but do they have a benefit on patient-oriented outcomes? This trial recruited 27,564 patients with known vascular disease (MI, stroke, or peripheral arterial disease) and at least one major additional risk factor (e.g., diabetes mellitus, smoking, age 65 years or older) or two minor risk factors (e.g., high-density lipoprotein level less than 40 mg per dL [1.04 mmol per L], high-sensitivity C-reactive protein level greater than 2.0 mg per L [19.05 nmol per L], LDL level of 130 mg per dL [3.37 mmol per L] or greater). This was an extremely high-risk group, which is important to keep in mind. All patients had to be taking a high-intensity statin yet still have a fasting LDL level of at least 70 mg per dL (1.81 mmol per L). The mean age of participants was 62 years, 75% were men, 85% were white, and most came from Europe. The most common type of vascular disease was a history of previous MI (81%).

The patients were randomized to receive evolocumab injections (140 mg per week or 420 mg per month at the patient's discretion) or placebo injection. The groups were balanced at the start of the study, and analysis was by intention to treat. The drug certainly lowers the LDL level, from a median of 92 mg per dL (2.38

POEMs (patient-oriented evidence that matters) are provided by EssentialEvidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see http://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=oxford.

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This series is coordinated by Sumi Sexton, MD, Associate Deputy Editor.

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Sep 15, 2018

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