Amgen announced study data at the European Society of Cardiology (ESC) Congress 2016 demonstrating Repatha (evolocumab) consistently lowered low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH).

In the “Efficacy of evolocumab in patients across ECS/EAS CV risk subgroups,” research, a total of 2,532 patients across three, 12-week, Phase 3 studies, were categorized according to the four ESC/EAS risk criteria: very high, high, moderate, and low. Data from the analysis showed that treatment with Repatha 140mg every 2 weeks or 420mg monthly consistently reduced LDL-C levels and other lipids from baseline to the mean of Weeks 10 and 12 across all risk categories compared to placebo or ezetimibe controls. 

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Among high-risk patients, treatment with Repatha lowered LDL-C levels from baseline 65.2% more vs. placebo and 40.7% more vs. ezetimibe. Rates of overall adverse events were similar for the three groups, occurring in 43.1% of patients in the Repatha group, 50.5% in the ezetimibe group, and 40.8% in the placebo group. 

In the “Long-term safety, tolerability and efficacy of evolocumab in patients with heterozygous familial hypercholesterolaemia” research, study authors reported that treatment with Repatha for 48 weeks led to persistent and marked LDL-C reductions. Data from the analysis showed Repatha + standard of care lowered LDL-C levels from baseline by 53.6% at 48 weeks vs. a 2.1% increase with standard of care alone. The analysis had included 440 patients with heterozygous FH who completed the Phase 2 RUTHERFORD-1 or Phase 3 RUTHERFORD-2 trials and entered open-label extension trials (OSLER-1 or OSLER-2). Rates of overall adverse events were similar for the two groups, with 80% occurring in the Repatha group and 67% in the standard of care group. 

Repatha, a PCSK9 inhibitor, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) aged >13, who require additional lowering of LDL-C.

Repatha is available as 140mg/mL strength single-use prefilled syringes, as single-use prefilled SureClick autoinjectors, and as 420mg/3.5mL single-use Pushtronex on-body infusor systems. 

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