New Repatha analyses show efficacy and safety across risk groups

Consistently reduced low-density lipoprotein cholesterol in patients across cardiovascular risk subgroups or with familial hypercholesterolemia.

"These analyses continue to shape the clinical evidence for Repatha and help to advance our understanding of its potential to benefit patients," said Sean E. Harper, executive vice president of Research and Development at Amgen. "The data at ESC provide further insights into the impact of Repatha on multiple patient populations who are at higher cardiovascular risk and are in need of additional treatment options."

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 III 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 2 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% more than placebo and 40.7% more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1%, 50.5% and 40.8% 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% at 48 weeks (n=279), compared to a 2.1% increase for SoC alone. The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia (HeFH) who completed Amgen's RUTHERFORD-1 (Phase II) or RUTHERFORD-2 (Phase III) 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% of patients receiving Repatha and 67% of patients receiving SoC.

"These long-term data add to the growing body of evidence supporting Repatha's ability to meaningfully reduce LDL cholesterol levels in patients with familial hypercholesterolemia," said G. Kees Hovingh, Academisch Medisch Centrum, Vascular Medicine, Amsterdam, the Netherlands. "Familial hypercholesterolemia is an inherited condition that leads to high levels of LDL cholesterol from birth, and these high LDL cholesterol levels can result in increased risk for premature cardiovascular disease in patients with FH. This understanding is important for the HeFH patients in whom adequate control of their cholesterol levels with other currently approved lipid-lowering agents has been troublesome."

Additional data at the Congress included a Rapid Fire Abstract entitled, "Familial Hypercholesterolaemia Diagnosis: A Case of Missed Opportunity," which suggested that as few as 1 in 10 FH patients may be diagnosed. Patient-level data available in the Clinical Practice Research DataLink (CPRD), a UK-based general practice database, indicated a FH prevalence of 1.3 per 1,000 persons, which increased to 11.7 when missed diagnoses were counted.