REDUCE-IT: Icosapent ethyl reduces ischemic events in high-risk patients

Maybe in a couple of decades our researchers will finally have stroke put into the neurological disease category instead of the cardiovascular category.  Until then you will need to monitor CVD research. The WHO reclassified stroke in 2006, now a neurological disease not cardiovascular disease. So only 12 years of incompetency. 

REDUCE-IT: Icosapent ethyl reduces ischemic events in high-risk patients

Cardiology Today, December 2018

Deepak L. Bhatt

CHICAGO — In patients with elevated triglycerides at high CV risk despite statin therapy, icosapent ethyl was superior to placebo for reducing risk for ischemic events, according to results of the anticipated REDUCE-IT trial.
The trial of icosapent ethyl (Vascepa, Amarin Pharmaceuticals), a pharmaceutical-grade omega-3 fatty acid, enrolled 8,179 patients (median age, 64 years; 71% men) who had fasting triglycerides 135 mg/dL to 499 mg/dL despite taking statins and who had established CVD (70.7%) or diabetes plus other risk factors (29.3%). Patients were assigned icosapent ethyl 2 g twice daily or placebo and followed for a median of 4.9 years. All had LDL levels ranging from 41 mg/dL to 100 mg/dL.

Reduction in CV events
The primary endpoint of CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina occurred less often in the icosapent ethyl group compared with the placebo group (17.2% vs. 22%; HR = 0.75; 95% CI, 0.68-0.83; P = .00000001; absolute difference, 4.8%; 95% CI, 3.1-6.5; number needed to treat to prevent one primary endpoint event = 21; 95% CI, 15-33), Cardiology Today’s Intervention Chief Medical Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, reported at the American Heart Association Scientific Sessions.
“Treatment with icosapent ethyl significantly reduced cardiovascular events, including a 20% reduction in cardiovascular death, a 31% reduction in heart attack, a 28% reduction in stroke and a low rate of adverse events,” Bhatt said during a presentation. “There was a consistent benefit across all subgroups, including in the primary and secondary prevention cohorts.”
The key secondary endpoint, defined as CV death, nonfatal MI or nonfatal stroke, was also lower in the icosapent ethyl group (11.2% vs. 14.8%; HR = 0.74; 95% CI, 0.65-0.83; P = .0000006; absolute difference, 3.6%; 95% CI, 2.1-5; number needed to treat to prevent one key secondary endpoint event = 28; 95% CI, 20-47).
The researchers also performed hierarchical testing of additional ischemic endpoints. In this analysis, the rates of the additional ischemic endpoints, including death from CV causes, were also lower in the icosapent ethyl group (4.3% vs. 5.2%; HR = 0.8; 95% CI, 0.66-0.98).

Carl E. Orringer

“The highly significant reductions in the primary and secondary cardiovascular endpoints in the presence of relatively modest effects of blood lipids and lipoproteins suggest the possibility that other properties of this drug such as the antithrombotic or anti-inflammatory effects” could have prompted the results, Carl E. Orringer, MD, FACC, FNLA, associate professor of medicine at University of Miami Miller School of Medicine, said during a discussant presentation at the press conference.