image: investigator Michelle O’Donoghue, MD, MPH, a senior investigator of the TIMI Study Group in the Division of Cardiovascular Medicine view more
Credit: Michelle O'Donoghue/Brigham and Women's Hospital
A clinical trial led by investigators from Brigham and Women’s Hospital has found that the long-term use of the cholesterol lowering drug evolocumab was safe, well tolerated, and led to further reductions in the risk of cardiovascular events compared to shorter treatment. Findings from the trial, known as FOURIER open-label extension (OLE), sponsored by Amgen, were presented at a Hot Line session at ESC Congress 2022 by the study’s principal investigator Michelle O’Donoghue, MD, MPH, a senior investigator of the TIMI Study Group in the Division of Cardiovascular Medicine. More than 6,000 participants from the parent trial were enrolled in FOURIER-OLE. During the extension period of the trial, patients received open-label subcutaneous injections of the PCSK9 inhibitor evolocumab regardless of whether they were originally randomized to receive the drug or the placebo. Participants were followed for a median of five years and, therefore, some patients were treated with evolocumab for more than eight years over the course of the parent and extension phase. Those originally randomized to receive evolocumab had a 15 percent lower risk of cardiovascular death, myocardial infarction (MI), stroke, hospitalization for unstable angina or coronary revascularization; a 20 percent lower risk of cardiovascular death, MI or stroke; and a 23 percent lower risk of cardiovascular death during OLE compared to those who were originally randomized to receive the placebo.
“To date, most clinical trials of PCSK9 inhibitors like evolocumab have only looked at its impact over two to three years, but most patients will be on a lipid-lowering therapy for many years,” said O’Donoghue. “Our study has found that long-term use of evolocumab was safe and led to further reductions in cardiovascular events among those who were started on the drug earlier, providing further support for guidelines recommending lipid-lowering therapy with PCSK9 inhibitors.”
Read more in Circulation.
Journal
Circulation
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
Long-Term Evolocumab in Patients with Established Atherosclerotic Cardiovascular Disease
Article Publication Date
29-Aug-2022
COI Statement
Dr. O’Donoghue has received grant funding via Brigham and Women’s Hospital from Amgen, Novartis, AstraZeneca, Janssen, Intarcia and GlaxoSmithKline and consulting fees from Amgen, Novartis, AstraZeneca and Janssen. Dr. Giugliano reports personal fees from Medical Education Resources, personal fees from Amarin, personal fees from AstraZeneca, grants and personal fees from Amgen, personal fees from Boeringer-Ingelheim, personal fees from Bristol Myers Squibb, personal fees from CVS Caremark, grants and personal fees from Daiichi Sankyo, personal fees from CryoLife, personal fees from Janssen, personal fees from Medscape, grants and personal fees from Merck, personal fees from CSL Behring, personal fees from Pfizer, personal fees from Servier, personal fees from CryoLife, personal fees from Esperion, personal fees from Gilead, personal fees from Eli Lilly, personal fees from Samsung, grants from Anthos, personal fees from SAJA Pharmaceuticals, personal fees from Dr. Reddy's Laboratories, personal fees from Centrix, personal fees from Hengrui, personal fees from Inari, personal fees from Novartis, personal fees from PhaseBio, personal fees from St Luke's Hospital System, personal fees from Menarini, personal fees from Shanghai Medical Group, personal fees from VoxMedia, grants from Ionis, personal fees from Bayer, personal fees from LabCorp, grants and personal fees from Sanofi Aventis, personal fees from Paratek, personal fees from Caladrius, outside the submitted work; and Institutional research grant to the TIMI Study Group at Brigham and Women's Hospital for research he is not directly involved in from Abbott; Aralez; AstraZeneca; Bayer; Eisai; GlaxoSmithKline; Intarcia; Janssen Research and Development; Medicines Company; MedImmune; Novartis; Poxel; Pfizer; Quark Pharmaceuticals; Roche; Takeda; Zora Biosciences. Dr. Atar reports reports speaker’s honoraria and consultancy fees from Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Pfizer, Merck, Novartis and Sanofi-Regeneron; and research funding to his institution from Bristol Myers Squibb, Pfizer, Medtronic and Roche Diagnostics. Drs. Abbasi, Lopez, Monsalvo, Elliott-Davey, Flores-Arredondo and Wang are employees of Amgen. Dr. Sabatine reports Research grant support through Brigham and Women’s Hospital from Abbott; Amgen; Anthos Therapeutics; AstraZeneca; Daiichi-Sankyo; Eisai; Intarcia; Ionis; Medicines Company; MedImmune; Merck; Novartis; Pfizer and consulting for: Althera; Amgen; Anthos Therapeutics; AstraZeneca; Beren Therapeutics; Bristol-Myers Squibb; DalCor; Dr. Reddy’s Laboratories; Fibrogen; Intarcia; Merck; Moderna; Novo Nordisk; Silence Therapeutics