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Background:  Evolocumab is the first monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) approved in Japan for the treatment of patients with familial hypercholesterolemia (FH) and hypercholesterolemia (HC). This study assessed the 12-week effectiveness and safety of low-density lipoprotein cholesterol (LDL-C)-lowering therapy by PCSK9 inhibition in patients with FH (homozygous [HoFH] or heterozygous [HeFH]) and HC by analyzing evolocumab data collected in the real-world setting in Japan.  Methods and Results:  Overall, 427 patients (mean±SD age, 61.6±13.8 years; female, 38.4%; 28 HoFH, 320 HeFH, 79 HC), enrolled from 299 clinical sites, were included in the safety analysis set. The major cardiovascular risk factors were coronary artery disease (77.3%), diabetes mellitus/impaired glucose tolerance (38.6%), and hypertension (65.1%). Median follow-up duration was 85.0 days. After 12 weeks of evolocumab treatment, the mean±SD percent change from baseline in LDL-C was -45.5%±27.0% (n=23) in HoFH (P&lt;0.001 vs. baseline; t-test), -54.2%±29.0% (n=280) in HeFH (P&lt;0.001), and -64.6%±22.4% (n=72) in HC (P&lt;0.001) patients. The incidence of adverse drug reactions was 5.4% (23/427).  Conclusions:  Results suggest that patients receiving evolocumab treatment in the real-world setting were predominantly those with FH and HC in the secondary prevention group. LDL-C-lowering effectiveness with evolocumab was observed in FH (both HoFH and HeFH) and HC patients.

circulation reports

12-Week Effectiveness and Safety of Low-Density Lipoprotein Cholesterol-Lowering Therapy by Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition in Patients With Familial Hypercholesterolemia and Hypercholesterolemia ― Data From a Real-World Observational Study of Evolocumab in Japan ―