NICE does not recommend icosapent ethyl for prevention of cardiovascular events
pharmafile | March 28, 2022 | News story | Sales and Marketing |Â Â Â
NICE has published further draft guidance for public consultation which does not recommend VAZKEPA (icosapent ethyl) for reducing the risk of cardiovascular events in adults who have raised levels of triglycerides.
Triglycerides are a type of blood fat or lipid, and are our main source of energy and are essential for good health. However, too much in your blood can raise te risk of cardiovascular events, such as heart attacks or strokes.
Icosapent ethyl is the first treatment that aims to reduce the risk of cardiovascular events in adults who are already taking statins, have raised levels of triglycerides, have established cardiovascular disease or diabetes, and at least one other cardiovascular risk factor (such as hypertension or being aged 55 or older).
Results from clinical trials have suggested the use of icosapent ethyl in people with established cardiovascular disease, which reduces the risk of cardiovascular events. However, the evidence on its use by adults who don’t have cardiovascular disease, but who have diabetes and at least one cardiovascular risk factor is less apparent.
It is also unclear how well icosapent ethyl works, as it was compared with a placebo (mineral oil), that may itself increase cardiovascular risk. The trial also may not be generalisable to the NHS; several treatments available in the NHS for the management of high-risk cardiovascular disease and diabetes were used by only a small proportion of people in the trial.
It is believed that between 25% and 35% of people having statin therapy still have elevated triglycerides, and around 730,000 people in England would have been eligible for icosapent ethyl if NICE had recommended it.
Amarin is currently working with NICE, and actively collaborating with all stakeholders involved in this process, to ensure that VAZKEPA is made available to all relevant patients who are at risk of ha heart attack or stroke. NICE’s Final Appraisal Document is expected in three weeks, meaning that whilst VAZKEPA has not yet received a recommendation, it could potentially still be recommended when the FAD is published.
Lina Adams
