New guidance about the use of icosapent ethyl (Vazkepa) for reducing cardiovascular (CV) risk, issued by the National Institute for Health and Care Excellence (NICE), is expected to benefit around 425,000 people in England treated on the country’s free National Health Service (NHS).1
NICE has recommended icosapent ethyl as an option for reducing the risk of CV events (eg. myocardial infarction and stroke) in adults. The agent is recommended for adults with a high risk of CV events and raised fasting triglycerides (1.7 mmol/L or above) who are taking statins, but only if they have:
- Established CV disease (secondary prevention), defined as a history of any of the following:
- Acute coronary syndrome (eg. MI or unstable angina needing hospitalisation)
- Coronary or other arterial revascularisation procedures
- Coronary heart disease
- Ischaemic stroke
- Peripheral arterial disease, and
- Low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/L
Helen Knight, Interim Director of Medicines Evaluation at NICE, said: “Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well controlled LDL cholesterol because they have raised blood fats. And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.
“We have worked closely with the company to identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding, delivering maximum value to the taxpayer.”
The NICE recommendation is based on data from the REDUCE-IT trial which showed a 25% reduction in the composite of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation and unstable angina in patients with CV disease and raised triglycerides who were taking statins (17.2% with icosapent ethyl vs 22.0% with placebo, hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; p<0.001).2
Icosapent ethyl is currently approved and sold as Vascepa in the USA, Canada, Lebanon and the United Arab Emirates, and as Vazkepa in Germany, Sweden, the UK and Denmark.
- National Institute for Health and Care Excellence. Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides. Technology appraisal guidance [TA805], 13 July 2022.
- Bhatt DL, Steg PG, Miller M et al; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. https://www.nejm.org/doi/full/10.1056/nejmoa1812792