Data presented at the American College of Cardiology’s 63rd Annual Scientific Session showed that evolocumab (Amgen) significantly reduced low-density lipoprotein (LDL) cholesterol as an add-on to statins in all treatment groups. Evolocumab is a monoclonal antibody that works by inhibiting PCSK9, which leads to an increase in the liver’s ability to clear LDL cholesterol from the blood.
LAPLACE-2 was a Phase 3 study that evaluated evolocumab in reducing LDL cholesterol. Patients were first randomized to a high-intensity (eg, atorvastatin 80mg, rosuvastatin 40mg) or moderate-intensity (eg, simvastatin 40mg, atorvastatin 10mg, rosuvastatin 5mg) statin. After patients (n=1,899) were stabilized on one of the 5 lipid-control regimens, they were randomized to different doses and schedules of evolocumab or placebo, evolocumab + placebo, placebo + ezetimibe, or placebo only.
All evolocumab-treated groups showed highly significant reductions in LDL cholesterol vs. placebo. Some of the results were as follows:
- 66–75% reduction with evolocumab injections every 2 weeks or 63–75% on a 4-week schedule
- Patients achieved an LDL cholesterol level of <70mg/dL in 86–94% in the moderate-intensity statin groups and 93–95% in the high-intensity groups
- Ezetimibe reduced LDL cholesterol by 17–20% in moderate-intensity statin groups and 51–62% in high-intensity groups
- Adding evolocumab reduced LDL cholesterol levels to 39–49mg/dL with moderate-intensity statin regimens and 33–39mg/dL with high-intensity regimens
Evolocumab also significantly reduced non-HDL cholesterol, apolipoprotein B and lipoprotein (a) levels. The researchers concluded that the study’s safety and efficacy endpoints were met.
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