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Top-line results from two open label extension studies of Repatha over five years for atherosclerotic cardiovascular disease.- Amgen

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Published:28th Apr 2022

Amgen announced top-line results from two Repatha (evolocumab) open label extension (OLE) studies to the Phase III FOURIER cardiovascular outcomes trial. The studies were designed to assess the long-term safety and tolerability of Repatha over five years in adults with clinically evident atherosclerotic cardiovascular disease.

 

The FOURIER-OLE (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated – Risk-Open Label Extension) studies were composed of study 20130295 (NCT02867813) with 5,035 patients enrolled in Eastern Europe and the United States and study 20160250 (NCT03080935) with 1,600 patients enrolled in Western Europe. Both studies showed that Repatha, administered at 140 mg every two weeks or 420 mg monthly, was safe and well-tolerated. In the OLE studies, patients received Repatha for approximately 5 years, with some patients receiving Repatha for up to 8 1/2 years in aggregate across the FOURIER and OLE studies. No new long-term safety findings were observed.

In addition, medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) levels were observed, with more than 85 percent of patients achieving an LDL-C level of <40 mg dl during the ole period.></40>

Other study measures included exploratory analyses of non-high-density lipoprotein cholesterol, apolipoprotein B, total cholesterol, Lipoprotein(a), triglycerides, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, and apolipoprotein A-1 levels, as well as cardiovascular events of interest.

Detailed study results will be shared with regulatory authorities and submitted for presentation at an upcoming medical congress later this year. Prolonged LDL-C reduction with Repatha is also being studied in the ongoing VESALIUS-CV (NCT03872401) outcomes trial.

Repatha Cardiovascular Open-Label Extension (FOURIER-OLE) Study Design : FOURIER (20110118) was a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. FOURIER-OLE (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated – Risk-Open Label Extension) were multicenter, open-label extension (OLE) studies designed to assess the extended long-term safety of evolocumab in subjects who completed the FOURIER study (20110118). The FOURIER-OLE is composed of studies 20130295 and 20160250, which enrolled 5,035 and 1,600 subjects who completed FOURIER study (20110118) to receive open-label evolocumab and were followed up for a median of 5 and 4.6 years, respectively.

PROFICIO Program :FOURIER is part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) program of clinical studies investigating the impact of Repatha on LDL-C and CVD across multiple populations at high CV risk, including those managed by statins, statin-intolerant patients, those with genetic disorders and patients with atherosclerosis. To date, the PROFICIO program consists of 36 trials including more than 38,000 patients worldwide.

Condition: Dyslipidaemia
Type: drug

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