The National Institute for Health and Care Excellence (NICE) have recommended the use of Vazkepa in the care of adult patients receiving statin treatment, who are considered to be at increased risk for cardiovascular disease, who have been found to have raised serum triglycerides, and/or have existing diagnosed cardiovascular disease.
In the 2020, in the England and Wales, there were 55,587 deaths due to ischaemic heart diseases, and 29,610 deaths due to cerebrovascular diseases. These conditions represent a significant health burden in the UK, and innovation in treatment is needed to reduce mortality in line with the increase in certain risk factors, such as diabetes and increased age which are rising over time.
“NICE recommend Vazkepa (icosapent ethyl) for adults at risk of myocardial infarction“
Vazkepa is the first in its drug class to be recommended for cardiovascular reduction by NICE. It is comprised of a purified omega-3 fatty acid works by reducing triglyceride levels, which are associated with risk of ischaemic changes in cardiovascular tissue, and risk of venous thromboembolism, such as stroke or deep vein thromboses.
The safety and efficacy of Vazkepa was assessed in the randomised, double-blind, placebo-controlled phase 3b trial, REDUCE-IT. A total of 8179 patients were randomised into a treatment group or a placebo group. Those in the treatment group received 2g twice daily with food of icosapent ethyl (Vazkepa), or a placebo. Randomisation was stratified according to cardiovascular risk, so that each group contained individuals who may be classified as a primary-prevention or secondary-prevention individual, according to their medical history and existing risk factors. Primary-prevention was capped at 30% of the patients enrolled in the trial. Stratification also took into consideration the patient’s use of ezetimibe, and their geographic region.
Inclusion criteria for this trial included being 45 years old or above with a known cardiovascular disease, or 50 years of age or older with a diagnosis of diabetes mellitus and one additional risk factor for ischaemic heart disease, and a fasting triglyceride level of 150-499 mg/dL and a low-density lipoprotein (LDL) cholesterol level of 41-100 mg/dL, and had been receiving a stable dose of statins for a minimum of 4 weeks. Additionally, the study excluded patients with severe heart failure, active and severe liver disease, a glycated haemoglobin (Hba1c) level over 10%, were scheduled for coronary surgery, a history or current acute or chronic pancreatitis, known hypersensitivity responses against fish, shellfish, or any of the ingredients used in the placebo or icosapent ethyl (Vazkepa). The primary efficacy endpoint of the study was cardiovascular death, a nonfatal myocardial infarction, a nonfatal stroke, coronary revascularisation interventions, or unstable angina, in a time-to-event measurement.
There was a median decrease in triglyceride rise from baseline to 1 year by 18.3% in the treatment group compared to a rise in 2.2% in the placebo group. There was also a lesser median increase in serum LDL cholesterol from baseline to 1 year in the treatment group, who showed a 3.1% increase compared to 10.2% increase in the placebo group. The REDUCE-IT trial demonstrated that the use of Vazkepa can reduce triglycerides and slow rising LDL levels in individuals at high risk of ischaemic cardiovascular events. Additionally, safety profiles were comparable between the treatment and placebo group, although atrial fibrillation and bleeding complications were more common in the treatment group, however, overall rates were low.
The trial was sponsored by Amarin Pharma, who also developed the treatment protocol, data collection and interpretation, and collaborated with a steering committee comprised of academic doctors specialising in cardiovascular health.
Future studies may hope to elucidate the mechanism behind icosapent ethyl’s therapeutic benefit. Final guidance for the use of Vazkepa in clinical practice is expected to be released on the 20th July 2022.See all the latest jobs in Medical Devices