Evinacumab in Patients with Refractory Hypercholesterolemia

Lipoprotein metabolism in familial hypercholesterolemia

“…In a trial of patients with refractory hypercholesterolemia, defined as an LDL-C of greater than 1.8 mmol/l or greater than 2.6 mmol/l for those with or without clinical atherosclerotic disease despite treatment with maximally tolerated statin (with or without ezetimibe) and a PCSK9 monoclonal antibody, evinacumab given in varying doses either subcutaneously or intravenously reduced LDL-C in a dose-dependent manner by 24.2–56.0% compared with placebo. In this trial, 72% of patients had FH ( 120 ).…”

Lipid Lowering Drugs: Present Status and Future Developments

“…The superiority of evinacumab administered either sc or iv compared to placebo was also seen in patients with refractory hypercholesterolemia. Among 272 patients with LDL-C levels of 150±80.2 mg/dL despite use of other lipid-lowering medications including monoclonal PCSK9 inhibitors, evinacumab significantly reduced LDL-C by more than 50% at the maximum dose (450 mg/weekly sc regimen and 15mg/Kg every 4 weeks iv regimen) [62]. The pharmacokinetic profile of both regimens seems not to differ between ethnicities at least in the Caucasian and in the Japanese [63].…”

Highlights from Studies Presented at the American Heart Association Scientific Session 2020: Navigating New Roads in Prevention

“…Evinacumab is a fully human monoclonal antibody that neutralizes the effect of ANGPTL3. A previous phase 3 study of evinacumab in patients with homozygous familial hypercholesterolemia (FH) showed a between-group mean difference of 49% in reduction in LDL-C compared to placebo [5]. The present phase 2 clinical trial sought to evaluate the efficacy and safety of subcutaneous (SC) and intravenous (IV) evinacumab, compared to placebo, in patients with refractory hypercholesterolemia.…”

“…The studies include cardiovascular outcome trials evaluating the effects of omecamtiv [1•] and sotagliflozin [2••] on cardiovascular outcomes in patients with heart failure. We further highlight data from the STRENGTH (Long-Term Outcome Study to Assess Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia) trial assessing the effects of on omega-3 carboxylic acids (Epanova) cardiovascular outcomes in patients with high vascular risk and atherogenic dyslipidemia [3••]; the OMEMI (Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction) trial assessing effects of omega-3 fatty acids in elderly patients after myocardial infarction [4]; a phase 2 clinical trial studying efficacy and safety of evinacumab in patients with refractory hypercholesterolemia [5]; and RAPID-CTCA (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) trial studying the use of coronary computed tomography angiography for assessment of suspected acute coronary syndrome [6•]. In addition, we summarize the results of the International Polycaps Study (TIPS-3) on the use of a polypill for primary prevention of cardiovascular disease in intermediate-risk people [7], and, finally, discuss the SAMSON (Self-Assessment Method for Statin Side-Effects or Nocebo) trial-a three-arm-N-of-1 trial-to identify the root cause of the symptoms contributing to patient nonadherence to statin therapy [8•].…”