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Antibody Combined With Statin Results in Additional Lowering of Cholesterol Levels

by Bidita Debnath on May 15, 2014 at 1:30 AM
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 Antibody Combined With Statin Results in Additional Lowering of Cholesterol Levels

The addition of the human monoclonal antibody evolocumab resulted in additional lowering of low-density lipoprotein cholesterol (LDL-C) levels among patients with high cholesterol receiving moderate- or high-intensity statin therapy.

This is according to a study in the May 14 issue of JAMA. 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 2 studies, evolocumab use was associated with reduced LDL-C levels in patients receiving statin therapy, according to background information in the article.

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Jennifer G. Robinson, M.D., M.P.H., of the University of Iowa, Iowa City, and colleagues conducted a phase 3 study (LAPLACE-2) in which patients were assigned to 1 of 24 treatment groups in two steps. Initially, patients (n = 2,067) were randomly assigned to a daily, moderate-intensity statin (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]); or high-intensity statin (atorvastatin [80 mg], rosuvastatin [40 mg]). After four weeks, while continuing their statin therapy, patients (n = 1,899) were then randomly assigned to compare the effect of evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily, atorvastatin patients only; a nonstatin drug used to treat high cholesterol). The study was conducted at 198 sites in 17 countries.

Compared with placebo, evolocumab provided clinically equivalent percent reductions in LDL-C levels when administered every 2 weeks (66 percent to 75 percent) and monthly (63 percent to 75 percent) when added to moderate- or high-intensity statin therapy. The additional LDL-C lowering seen with evolocumab was greater than that observed with ezetimibe (up to 24 percent reduction).
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Evolocumab was well tolerated, with comparable rates of adverse events compared to placebo and ezetimibe during the 12-week treatment period.

"LAPLACE-2 is to our knowledge the first study to demonstrate that the addition of evolocumab results in similar percent reductions in LDL-C and achieved LDL-C levels regardless of stable baseline statin type, dose, or intensity, across 3 commonly prescribed statins and a broad range of doses," the authors write.

Source: Eurekalert
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