Amgen presents new cardiovascular research at AHA meeting

Amgen announced new data reinforcing the safety and efficacy of Repatha (evolocumab) from the FOURIER Open Label Extension (OLE) [FOURIER-OLE] trial at the American Heart Association (AHA) Scientific Sessions 2023 in Philadelphia. These presentations will focus on the reduction of a known cardiovascular disease (CVD) risk factor, LDL “bad” cholesterol (LDL-C). Amgen will also present new research from the Phase 2 OCEAN(a)-DOSE study of its investigational small interfering RNA (siRNA) olpasiran that will focus on a primarily genetically determined and presumed independent CVD risk factor, lipoprotein(a) [Lp(a)]

Repatha Data Reinforces Benefits of Low LDL-C ; Data from the EBBINGHAUS sub-study of the FOURIER-OLE is the first to evaluate the impact of long-term lowering of LDL-C on cognitive function following administration of Repatha in adult patients with atherosclerotic cardiovascular disease (ASCVD). The data showed patients treated with Repatha did not experience any apparent cognitive decline following a median achieved LDL-C of 34 mg/dL through a median follow-up period of 5.1 years.

“Cardiovascular disease is a leading public health crisis in the United States. Amgen remains steadfast in our commitment to reduce the risk of heart attack and stroke, starting with lowering levels of LDL-C, one of the most modifiable risk factors,” said Paul Burton, senior vice president and chief medical officer at Amgen. “Repatha continues to be an effective option in helping people with cardiovascular disease manage their LDL-C, and this FOURIER-OLE data further demonstrates that long-term lowering of LDL-C levels come with no decline in cognitive function.”

An additional analysis combining FOURIER and FOURIER-OLE data for 152 OLE participants originally randomized to receive Repatha showed that long-term treatment with this medication had no significant impact on measures of executive function, working and episodic memory, and psychomotor speed over time as compared to baseline. No new safety signals were identified in the analyses.

“The neurocognitive data highlighting long-term use of evolocumab is highly encouraging for the cardiovascular community,” said Robert Giugliano, M.D., S.M., Senior Investigator, TIMI Study Group, Staff Physician, Cardiovascular Medicine, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, and FOURIER-OLE investigator. “In addition to reiterating the neurocognitive safety of evolocumab, this study provides reassuring information for patients and clinicians that sustained very low levels of LDL-C over the long-term does not increase cognitive impairment.”

Olpasiran Research on Risks Associated with Elevated Lp(a) : Amgen also shared new research from the OCEAN(a)-DOSE study on Lp(a) involving its investigational olpasiran. Evidence suggests that elevated Lp(a) contributes to cardiovascular events, including heart attack, stroke and peripheral arterial disease. Data will be presented on the intraindividual variability in serial Lp(a) concentration among placebo-treated patients in the OCEAN(a)-DOSE trial. Additional research presented at AHA will include Mass General Brigham Lp(a) registry data on whether the association between Lp(a) and major adverse cardiovascular events (MACE) differs based on baseline ASCVD status. This research investigates the threshold for defining Lp(a) in patients both with and without ASCVD.

LDL-C Action Summit & LDL Awareness to Action Implementation Consortium: Amgen will reconvene the LDL-C Action Summit and the newly formed LDL Awareness to Action Implementation Consortium ahead of AHA. The LDL-C Action Summit brings together key CVD community stakeholders to discuss strategies and opportunities for collaboratively improving lipid management, while the Consortium convenes leading cardiovascular healthcare systems and research institutions to focus on improving LDL-C testing and accelerating the implementation of evidence-based approaches into clinical practice. Both initiatives are part of Amgen’s commitment to advancing its bold ambition of halving the number of heart attacks and strokes by 2030.