Taking the triglyceride-lowering prescription medicine icosapent ethyl cut the risk of stroke by an additional 36% in people at increased risk of cardiovascular disease who already have their bad cholesterol levels under control using statin medications, according to preliminary research to be presented at the American Stroke Association's International Stroke Conference 2021.
The study’s results do not apply to supplements available over-the-counter, stressed the statement released by the American Stroke Association.
"Icosapent ethyl is a new way to further reduce the risk of stroke in patients with atherosclerosis or who are at high risk of stroke, who have elevated triglyceride levels and are already taking statins," said Dr Deepak L Bhatt, lead author of the study and executive director of interventional cardiovascular programmes at the Brigham and Women's Hospital Heart & Vascular Centre in Boston.
Icosapent ethyl is a prescription medication that is a highly purified form of the omega-3 fatty acid eicosapentaenoic acid. "It is very different in terms of purity compared to omega-3 fatty acid supplements available over-the-counter, and these results do not apply to supplements," said Bhatt, who is also professor of medicine at Harvard Medical School.
Icosapent ethyl was first approved in July 2012 by the US Food and Drug Administration as an adjunct treatment to dietary changes to lower triglycerides in people with extremely high levels of triglycerides (higher than 500 mg/dL). Triglycerides are fats from food that are carried in the blood; normal levels for an adult are below 150 mg/dL.
In late 2018, the REDUCE-IT trial, an 8,000-person multinational study, demonstrated that icosapent ethyl could benefit people with heart disease, diabetes or triglyceride levels above 150 mg/dL and whose LDL (bad) cholesterol levels were already under control using statin medication. In the trial, adding icosapent ethyl (compared with a placebo) reduced the risk of serious cardiovascular events (heart attack, heart-related death, stroke, need for an artery-opening procedure or hospitalization for heart-related chest pain) by 25%.
In December 2019, the FDA approved icosapent ethyl as a secondary treatment to reduce the risk of cardiovascular events among adults with elevated triglyceride levels, and it is now recommended in some professional guidelines. Icosapent ethyl is not included in the American Heart Association's 2018 Cholesterol Guidelines that were published online prior to the availability of the REDUCE-IT primary results.
In the current analyses, REDUCE-IT Stroke, researchers performed an additional analysis of the impact of icosapent ethyl on stroke in the same 8,000 participants of the original REDUCE-IT trial.
They found: the risk of a first fatal or nonfatal ischemic stroke was reduced by 36% for patients treated with icosapent ethyl; for every 1,000 patients treated with icosapent ethyl for 5 years, about 14 strokes were averted; and the risk of a bleeding stroke was very low, and no difference was found among those taking icosapent ethyl.
"Know your triglyceride levels. If they are elevated, ask your doctor if you should be taking icosapent ethyl to further reduce your risk of heart attack and stroke," Bhatt said.
"Your doctor may also recommend that you change your diet, exercise, lose weight if needed to lower your triglyceride levels, and may prescribe a statin medication if you need to lower your LDL cholesterol levels."
"One study limitation is that icosapent ethyl may increase the risk of minor bleeding," Bhatt added.
Co-authors are Gabriel Steg; Michael Miller; Eliot A Brinton; Terry A Jacobson; Steven B Ketchum; Rebecca A Juliano; Lixia Jiao; Ralph T Doyle Jr; Craig Granowitz; Jean-Claude Tardif; John Gregson; C Michael Gibson; Megan C Leary; and Christie M Ballantyne
American Stroke Association's International Stroke Conference 2021 study abstract not yet available online
American Stroke Association release