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New Repatha (evolocumab) Analyses Show Efficacy And Safety Across Risk Groups In Results Presented At ESC Congress 2016

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Clinical Data
Researchers looking at the "Efficacy of evolocumab in patients across ESC/EAS CV risk subgroups," categorized a total of 2,532 patients from three, 12-week Phase 3 studies by the four ESC/European Atherosclerotic Society (EAS) risk criteria (very high, high, moderate and low). The analysis showed that treatment with Repatha 140 mg every two weeks or 420 mg monthly consistently reduced levels of LDL-C and other lipids from baseline to the mean of weeks 10 and 12 across all risk categories compared to placebo or ezetimibe controls. For example, among very high-risk patients, Repatha reduced LDL-C levels from baseline 65.2 percent more than placebo and 40.7 percent more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1 percent, 50.5 percent and 40.8 percent of patients on Repatha, ezetimibe and placebo, respectively.In another presentation, researchers looking at the "Long-term safety, tolerability and efficacy of evolocumab in patients with heterozygous familial hypercholesterolaemia," found that treatment with Repatha for 48 weeks resulted in persistent and marked LDL-C reductions in these patients. The analysis showed that Repatha plus standard of care (SoC) reduced LDL-C levels from baseline by 53.6 percent at 48 weeks (n=279), compared to a 2.1 percent increase for SoC alone (n=139). The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia (HeFH) who completed Amgen's RUTHERFORD-1 (Phase 2) or RUTHERFORD-2 (Phase 3) trials and entered open-label extension trials (OSLER-1 or OSLER-2). Patients were randomized in the extension trials to receive SoC alone or Repatha plus SoC. Repatha was well tolerated in the extension studies with no new safety signals. The rates of overall adverse events were similar for the two groups, occurring in 80 percent of patients receiving Repatha and 67 percent of patients receiving SoC.

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for CV disease.1-4 In the U.S., there are approximately 11 million people with atherosclerotic cardiovascular disease (ASCVD) and/or FH who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.5,6 More than 60 percent of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents. Among very high-risk patients, the percentage is increased to more than 80 percent.7 It is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.
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Occurred on:
Aug 28, 2016
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Related Keywords Evolocumab, Repatha, Efficacy, Safety, Esc Congress 2016