Evolocumab combined with statin results in further reduction of cholesterol levels

Among patients with high cholesterol receiving moderate- or high-intensity statin therapy, the addition of the human monoclonal antibody evolocumab resulted in additional lowering of low-density lipoprotein cholesterol (LDL-C) levels, according to a study in the May 14 issue of JAMA (Journal of the American Medical Association).

Many patients receiving moderate- or high-intensity statin therapy are unable to achieve recommended LDL-C goals, and consideration of non-statin therapy for additional LDL-C lowering has been recommended. In Phase II studies, evolocumab use was associated with reduced LDL-C levels in patients receiving statin therapy, according to background information in the article.

Jennifer Robinson, of the University of Iowa, Iowa City, and colleagues conducted a Phase III study (LAPLACE-2) in which patients were assigned to one of 24 treatment groups in two steps. Initially, patients (n = 2,067) were randomly assigned to a daily, moderate-intensity statin (atorvastatin [10mg], simvastatin [40mg], or rosuvastatin [5mg]); or high-intensity statin (atorvastatin [80mg], rosuvastatin [40mg]). After four weeks, while continuing their statin therapy, patients (n = 1,899) were then randomly assigned to compare the effect of evolocumab (140mg every two weeks or 420mg monthly) with placebo (every two weeks or monthly) or ezetimibe (10mg or placebo daily, atorvastatin patients only; a non-statin drug used to treat high cholesterol). The study was conducted at 198 sites in 17 countries.