Kosin Med J.  2020 Dec;35(2):125-132. 10.7180/kmj.2020.35.2.125.

Efficacy of Evolocumab in Patients with Hypercholesterolemia

• Jin X
• Kim MH
• Cho YR
• Park JS
• Song K
• Yuan SL

• KMID: 2510273
• DOI: http://doi.org/10.7180/kmj.2020.35.2.125

Abstract

Objectives
The FOURIER trial reported that inhibition of PCSK9 with evolocumab on a background of statin therapy lowered low-density lipoprotein (LDL) cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. Here, we report data from a single center focusing on the effect of a PCSK9 inhibitor antibody on hyperlipidemia.
Methods
We enrolled 29 hypercholesterolemia patients who had LDL cholesterol levels ≥ 70 mg per deciliter or nonHDL cholesterol ≥ 100 mg per deciliter and were divided into two groups (placebo n = 14, evolocumab n = 15), and participated in a 72 - 96 week, randomized, double-blind, placebo-controlled trial with statin therapy. Patients were randomly assigned to receive evolocumab (140 mg every 2 weeks or 420 mg monthly) or matched placebo via subcutaneous injection. Lipid changes during follow-up were analyzed.
Results
The median LDL cholesterol level at baseline was 88 mg per deciliter, and the average LDL cholesterol level was 101.8 ± 20.0 mg per deciliter. At 4 weeks, the median LDL cholesterol level was 39 mg per deciliter, and the average LDL cholesterol level was 34.8 ± 51.8 mg per deciliter. Compared to placebo group, the LDL cholesterol levels were significantly reduced after treatment (P < 0.001), as well as total cholesterol, ApoB, and ApoB / ApoA1 levels. During follow-up, no discomfort was reported at local injection sites, and no cases of abnormal liver function were observed.
Conclusions
Evolocumab significantly reduced LDL cholesterol levels and was well tolerated.

Keyword

Cholesterol LDL; Hypercholesterolemia; Proprotein convertase; Subtilisin-kexin type 9

Figure

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  Fig. 1 Effect of Evolocumab on Levels of Low-Density Lipoprotein Cholesterol EOS = end of study, other abbreviations as for Table 1.

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  Fig. 2 Changes in Lipid Profile Following Evolocumab Administration Abbreviations as for Table 1.

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  Fig. 3 Changes in Hepatic Enzyme During Follow-up Abbreviations as for Figure 1 and Table 2.

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