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New Findings from Cleveland Clinic Update Understanding of Cholesterol (Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients With Statin...

July 23, 2014

New Findings from Cleveland Clinic Update Understanding of Cholesterol (Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients With Statin Intolerance)

By a News Reporter-Staff News Editor at Biotech Week -- Research findings on Cholesterol are discussed in a new report. According to news originating from Cleveland, Ohio, by NewsRx correspondents, research stated, "This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses. Statin intolerance, which is predominantly due to muscle-related side effects, is reported in up to 10% to 20% of patients."

Our news journalists obtained a quote from the research from Cleveland Clinic, "Evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), demonstrated marked reductions in plasma low-density lipoprotein cholesterol (LDL-C) in a phase 2 study in statin-intolerant patients. The GAUSS-2 (Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) trial was a 12-week, double-blind study of randomized patients (2: 2: 1: 1) to evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg. Co-primary endpoints were percent change from baseline in LDL-C at the mean of weeks 10 and 12, and at week 12. Three hundred seven patients (age 62 +/- 10 years; LDL-C 193 +/- 59 mg/dl) were randomized. Evolocumab reduced LDL-C from baseline by 53% to 56%, corresponding to treatment differences versus ezetimibe of 37% to 39% (p < 0.001). Muscle adverse events occurred in 12% of evolocumab-treated patients and 23% of ezetimibe-treated patients. Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups."

According to the news editors, the research concluded: "Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing the largely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant."

For more information on this research see: Anti-PCSK9 Antibody Effectively Lowers Cholesterol in Patients With Statin Intolerance. Journal of the American College of Cardiology, 2014;63(23):2541-2548. Journal of the American College of Cardiology can be contacted at: Elsevier Science Inc, 360 Park Ave South, New York, NY 10010-1710, USA (see also Cholesterol).

The news correspondents report that additional information may be obtained from E. Stroes, Cleveland Clinic, Dept. of Cardiovasc Med, Cleveland, OH 44106, United States. Additional authors for this research include D. Colquhoun, D. Sullivan, F. Civeira, R.S. Rosenson, G.F. Watts, E. Bruckert, L. Cho, R. Dent, B. Knusel, A. Xue, R. Scott, S.M. Wasserman and M. Rocco.

Keywords for this news article include: Ohio, Antibodies, Cleveland, Immunology, Cholesterol, United States, Blood Proteins, Immunoglobulins, North and Central America

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Source: Biotech Week

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