Evolocumab Lowers LDL-C in Two More Trials

January 31, 2014

THOUSAND OAKS, CA – The addition of evolocumab (Amgen, Thousand Oaks, CA) to a statin, compared with a statin alone, significantly lowered LDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, according to the top-line results of the LAPLACE-2 study announced this week[1].

The full results of LAPLACE-2 will be presented by Dr Jennifer Robinson (University of Iowa, Iowa City) on March 30, 2014 during the late-breaking clinical-trials session of the American College of Cardiology Scientific Sessions in Washington, DC. Companies regularly disclose top-line results of trials that can have a material effect on stock prices.

Evolocumab is an investigational human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9). Like other top-line results announced earlier, including GAUSS-2 , MENDEL-2 , and DESCARTES , the company said LAPLACE-2 met both co–primary end points, including the percent reduction from baseline in LDL-cholesterol levels at week 12 and the mean percent reduction from baseline in LDL-cholesterol levels at weeks 10 and 12.

The LAPLACE-2 study included 1896 patients with elevated cholesterol levels and mixed dyslipidemia. The trial is unique in that it has 24 comparator arms, including patients treated with evolocumab (140 mg every two weeks or 420 mg once monthly) and subcutaneous placebo (every two weeks or monthly) or ezetimibe (Zetia, Merck) when added to different daily doses of statin therapies.

In addition, the company announced that RUTHERFORD-2 met its primary end point[2]. This trial included 329 patients with heterozygous familial hypercholesterolemia randomized to one of four treatment groups, including subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) or placebo (placebo injected every two weeks or once monthly).

The GAUSS-2 study, whose top-line results were reported last week by heartwire , will be presented during the same late-breaking clinical-trials session by Dr Erik Stroes (Academic Medical Center, Amsterdam, the Netherlands). In that study, the treatment of statin-intolerant patients with evolocumab significantly lowered LDL-cholesterol levels.

Amgen sponsored the LAPLACE-2, RUTHERFORD, GAUSS-2, MENDEL-2, and DESCARTES studies.


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