Could evolocumab become the gold-standard in cholesterol reduction?
- Amgen's Evolocumab (AMG-145) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.
- In a phase III trial published in the New England Journal of Medicine (NEJM), adding evolocumab to either diet alone, low-dose atorvastatin or high-dose atorvastatin with or without ezetimbe significantly reduced low-density lipoprotein cholesterol (LDL-C) levels across patient groups.
- Evolocumab is viewed as a potentially promising add-on treatment for individuals with a genetic predisposition to high cholesterol, those who can’t handle higher doses of statins and those who are unable to achieve target LDL-C levels regardless of their therapeutic regimen.
According to guidelines from the National Cholesterol Education Program (NCEP), having LDL-C levels below 100 is optimal and can reduce the risk of cardiovascular (CVD) events. In a phase III study of 901 patients with hyperlipidemia, the overall mean reduction in LDL-C among evolocumab-treated patients was 57+2.1% (P<0.001).
Many people who are on statin therapy do not achieve target LDL-C levels, and there has long been an unmet medical need for an add-on agent that can successfully lower lipid levels in this population. Furthermore, the popular vascular treatment option niacin has recently come under scrutiny for potentially harming patients. It seems quite possible that evolocumab and others in its class may finally provide a therapeutic solution to this problem. The next goal: FDA approval.
- New England Journal of Medicine A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
- www.healthine.com Another study on the effects of evolocumab shows that it's successful at lowering LDL cholesterol levels in some patients.