Hell this was already approved by the FDA, why more research?
FDA approves CV event risk reduction indication for icosapent ethyl January 2020
The latest here:
Icosapent ethyl cuts stroke events in high-risk patients
The triglyceride-lowering drug icosapent ethyl reduced stroke incidence in high-risk patients taking statins, according to research presented at the American Stroke Association’s virtual International Stroke Conference.
“Compared with placebo, icosapent ethyl 4 g per day significantly reduced first and total strokes by 28% and 32%, respectively, and significantly reduced first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke in statin-treated patients with elevated CV risk,” Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said during a presentation.
In the REDUCE-IT trial, 8,179 patients, 70.7% with atherosclerotic CVD requiring secondary prevention and 29.3% with diabetes and at least one CV risk factor, were randomly assigned to icosapent ethyl (Vascepa, Amarin) 4 g per day or to a placebo, Bhatt said.
To qualify for the trial, patients had to have triglyceride levels of 135 mg/dL to 499 mg/dL and LDL levels of 40 mg/dL to 100 mg/dL.
Researchers found that at 5 years, first fatal or nonfatal stroke occurred in 2.4% of the icosapent ethyl group and 3.3% of the placebo group (HR = 0.72; 95% CI, 0.55-0.93; P = .01) with a relative risk reduction of 28%, an absolute risk reduction of 0.9% and a number needed to treat of 114.
According to researchers, for every 1,000 patients treated with icosapent ethyl for 5 years, nearly 14 fatal or nonfatal strokes were prevented (RR = 0.68; 95% CI, 0.52-0.91; P = .008).
First-event ischemic strokes occurred in 2% of the icosapent ethyl group and 3% of the placebo group, a 36% reduction (HR = 0.64; 95% CI, 0.49-0.85; P = .002), the researchers wrote in an abstract.
Hemorrhagic stroke occurred at low rates with no meaningful
difference for icosapent ethyl vs. placebo (0.3% vs. 0.2%, respectively;
P = .55), the researchers wrote in an abstract.
In his presentation, Bhatt noted that across multiple subgroups, there were generally consistent reductions in ischemic stroke.
“Pure eicosapentaenoic acid-based treatment with icosapent ethyl represents a novel approach to stroke reduction,” Bhatt said during the presentation.
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