American College of Cardiology

American College of Cardiology

Perspective from Robert S. Rosenson, MD
March 18, 2019
4 min read
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Prescription fish oil cuts total ischemic events in new REDUCE-IT analysis

Perspective from Robert S. Rosenson, MD
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Deepak L. Bhatt
Deepak L. Bhatt

NEW ORLEANS — Icosapent ethyl, a pharmaceutical-grade omega-3 fatty acid, was in the spotlight again at the American College of Cardiology Scientific Session, with new data from the REDUCE-IT trial demonstrating a 30% reduction in total ischemic events, including first and subsequent events, in high-risk patients with elevated triglycerides.

As Cardiology Today previously reported, in the main results of REDUCE-IT, icosapent ethyl (Vascepa, Amarin) reduced risk for first ischemic events, defined as CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina by 25% compared with placebo in 8,179 statin-treated patients (median age, 64 years; 71% men) with triglycerides 135 to 499 mg/dL and LDL 41 to 100 mg/dL who had prior CVD or diabetes.

For the present analysis, presented by Cardiology Today’s Intervention Chief Medical Editor Deepak L. Bhatt, MD, and simultaneously published in the Journal of the American College of Cardiology, the researchers evaluated total — first and subsequent — ischemic events during a median follow-up of 4.9 years.

“The usual way of doing a randomized clinical trial is doing a time-to-first-event analysis,” Bhatt, 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, told Cardiology Today. “But what we did here is analyze that but also subsequent events. For example, if a patient had a myocardial infarction, that would count as a first event, and that would have been previously reported. But that patient could be at risk for a subsequent event, maybe a fatal stroke a year or two later. What we do in a recurrent and total events analysis is count those second or more events to see what the effect of the intervention might be.”

Icosapent ethyl, a pharmaceutical-grade omega-3 fatty acid, was in the spotlight again at the American College of Cardiology Scientific Session, with new data from the REDUCE-IT trial demonstrating a 30% reduction in total ischemic events, including first and subsequent events, in high-risk patients with elevated triglycerides.
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During the study period, 55.2% of events were first events, but the rest were a patient’s second event or more, the researchers reported.

Total primary endpoint events were reduced by 30% with icosapent ethyl compared with placebo (61 per 1,000 patient-years vs. 89 per 1,000 patient-years; RR = 0.7; 95% CI, 0.62-0.78).

“We found that second events were reduced by 32%, third events by 31% and fourth or more events by 48%, for a total event reduction of 30%,” Bhatt told Cardiology Today. “This is larger in effect size and in terms of statistical significance than the primary results, and confirms the robust effect of icosapent ethyl vs. placebo. Another way of looking at it is for every 1,000 patients, over 5 years we would prevent 159 ischemic events including 12 cardiovascular deaths. This puts into perspective how high-risk in terms of risk factors these patients are, how triglycerides further identify at-risk patients and how icosapent ethyl can substantially reduce the risk in these patients.”

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Total events were also reduced with icosapent ethyl in each component of the primary outcome, as well as in CV death/nonfatal MI/nonfatal stroke (32 per 1,000 patient-years vs. 44 per 1,000 patient-years; RR = 0.72; 95% CI, 0.63-0.82).

When the researchers stratified the cohort into tertiles by triglyceride level, risk was greatest in the highest tertile than in the other groups, and the treatment effect of icosapent ethyl was also greater, Bhatt told Cardiology Today.

“These data put into perspective what the role of icosapent ethyl might be in cardiovascular medicine,” he said. – by Erik Swain

References:

Bhatt DL, et al. Late-Breaking Clinical Trials IV. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.

Bhatt DL, et al. J Am Coll Cardiol. 2019;doi:10.1016/2019.02.032.

Disclosures: The study was funded by Amarin. Bhatt reports he has financial ties with multiple pharmaceutical and device companies, including Amarin. Please see the study for the other authors’ relevant financial disclosures.