This article is more than 5 years old. Information may no longer be current.
REDUCE-IT topline results announced: Icosapent ethyl reduces CV events
Amarin announced today topline results from the REDUCE-IT CV outcomes trial showing that the trial met its primary endpoint demonstrating approximately 25% RR reduction in major adverse CV events in the intent-to-treat population with use of icosapent ethyl compared with placebo.
“The composite cardiovascular event reduction of 25% with a very high level of statistical significance is a game changer,” Norman E. Lepor, MD, FACC, FAHA, FSCAI, past president of the California chapter of the American College of Cardiology, clinical professor of medicine at UCLA Geffen School of Medicine, attending cardiologist at Cedars-Sinai Heart Institute, co-director of Cardiovascular Imaging-Westside Medical Center, director of clinical research at Westside Medical Associates of Los Angeles and primary investigator of the REDUCE-IT trial, told Cardiology Today. “This trial answers a very important question relevant to a very large number of patients and addresses a good part of the residual risk.”
REDUCE-IT is a global study of 8,179 adults with elevated CV risk treated with statins. Patients enrolled had an LDL between 41 mg/dL and 100 mg/dL and various risk factors, including persistent elevated triglycerides and established CVD (secondary prevention cohort) or diabetes and at least one other CV risk factor (primary prevention cohort). Median follow-up in REDUCE-IT was 4.9 years, according to an Amarin press release.
“I can attest to the integrity of those who designed the trial protocol, managed the trials including my own clinical research staff to careful screen the appropriate subjects for this trial, to track patient compliance and adverse events and keep the subjects motivated to continue in this long-term trial and adhere to good clinical practice principles,” Lepor said in an interview.
The topline results were announced in advance of the late-breaking clinical trial presentation scheduled for the American Heart Association Scientific Sessions in November. The efficacy finding showed approximately 25% RR reduction in the primary endpoint of first occurrence of major adverse CV events, including CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina requiring hospitalization with icosapent ethyl (Vascepa, Amarin) treatment. The safety finding showed that icosapent ethyl was well-tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling. Adverse events were similar between the treatment and placebo groups, according to the release.
“Vascepa has unique characteristics that will not allow me to extrapolate the results from this trial to any other prescribed or over-the-counter fish oil preparation,” Lepor told Cardiology Today. “This drug does not take the place of statins in these patients, but is to be added to statins to further reduce cardiovascular risk. It also happens to be a drug that patients have little resistance to take and one that patients tend to comply with.”
“I look forward to the publication of these detailed REDUCE-IT results in a major peer-reviewed journal and to presenting them at the AHA in November,” Cardiology Today’s Intervention Chief Medical Editor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School, executive director of interventional cardiovascular programs in the Heart and Vascular Center at Brigham and Women’s hospital, and principal investigator and steering committee chair for REDUCE-IT, stated in the release. – by Katie Kalvaitis and Darlene Dobkowski
For more information:
Norman E. Lepor, MD, FACC, FAHA, FSCAI, can be reached at 99 La Cienega Blvd., #203, Beverly Hills, CA 90211.
Disclosures: Lepor and Bhatt are principal investigators for REDUCE-IT, and Bhatt is the steering committee chair for the trial.