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Antibody combined with statin results in further reduction of cholesterol levels

Date:
May 13, 2014
Source:
The JAMA Network Journals
Summary:
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 levels, according to a study. Compared with placebo, evolocumab provided clinically equivalent percent reductions in LDL-C levels when added to moderate- or high-intensity statin therapy. The additional LDL-C lowering seen with evolocumab was greater than that observed with ezetimibe.
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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.

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.

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).

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.


Story Source:

The above post is reprinted from materials provided by The JAMA Network Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Jennifer G. Robinson, Bettina S. Nedergaard, William J. Rogers, Jonathan Fialkow, Joel M. Neutel, David Ramstad, Ransi Somaratne, Jason C. Legg, Patric Nelson, Rob Scott, Scott M. Wasserman, Robert Weiss. Effect of Evolocumab or Ezetimibe Added to Moderate- or High-Intensity Statin Therapy on LDL-C Lowering in Patients With Hypercholesterolemia. JAMA, 2014; 311 (18): 1870 DOI: 10.1001/jama.2014.4030

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The JAMA Network Journals. "Antibody combined with statin results in further reduction of cholesterol levels." ScienceDaily. ScienceDaily, 13 May 2014. <www.sciencedaily.com/releases/2014/05/140513161718.htm>.
The JAMA Network Journals. (2014, May 13). Antibody combined with statin results in further reduction of cholesterol levels. ScienceDaily. Retrieved July 3, 2015 from www.sciencedaily.com/releases/2014/05/140513161718.htm
The JAMA Network Journals. "Antibody combined with statin results in further reduction of cholesterol levels." ScienceDaily. www.sciencedaily.com/releases/2014/05/140513161718.htm (accessed July 3, 2015).

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