The NHS Accelerated Access Collaborative (AAC)
England National Guidance for Lipid Management
for CVD prevention includes VAZKEPA1
VAZKEPA is indicated to reduce the risk of CV events in adult statin-treated patients at high CV risk with elevated triglycerides (≥150 mg/dL [≥1.7 mmol/L]) and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.2
The NHS AAC England National Guidance for Lipid Management for CVD prevention includes VAZKEPA as an additional CV risk reduction option in secondary CVD prevention in eligible adult patients.1
November 2022 updates to the NHS AAC England National
Guidance for Lipid Management for CVD prevention that are
relevant for VAZKEPA:
To prescribe VAZKEPA:
 |
Check fasting TG levels |
|
Manage secondary causes of hypertriglyceridaemia |
Consider VAZKEPA if the patient:1
|
Is on statins |
|
Has established CVD (secondary prevention in adult patients)
|
|
Has fasting TGs ≥1.7 mmol/L and LDL-C >1.04 and ≤2.6 mmol/L |
The use of VAZKEPA in CV risk reduction has also been recognised by its inclusion in other national and international guidelines1,3,4
2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice:3
- VAZKEPA may be considered in adult patients with established ASCVD, elevated fasting TG (≥1.7 mmol/L)* and controlled LDL-C (<1.4 mmol/L), in addition to a statin
2022 NICE Guideline TA805:4
- VAZKEPA is recommended by NICE as a treatment option to reduce the risk of CV events in eligible high CV risk statin-treated adult patients with established CVD,† elevated fasting TGs (≥1.7 mmol/L) and controlled LDL-C (>1.04 and ≤2.60 mmol/L)
*Value used within the guidelines: TGs >1.5 mmol/L. VAZKEPA is only licensed for use in adult patients with TGs ≥1.7 mmol/L. †Established CVD defined as a history of any of the following: acute coronary syndrome, coronary or other arterial revascularisation procedures, CHD, ischaemic stroke, PAD.4
VAZKEPA in secondary CVD prevention –
redefine residual CV risk reduction with VAZKEPA5
In the REDUCE-IT trial, VAZKEPA demonstrated a statistically significant reduction in the risk of 5-point MACE vs placebo5
First occurrence of composite 5-point MACE* (primary endpoint)5
Adapted from Bhatt DL, et al. N Engl J Med. 2019.5
All patients were on background statin therapy. Median follow-up 4.9 years.5
Number of patients with an event: Placebo 901/4,090; VAZKEPA 705/4,089.5
*5-point MACE was defined as a composite of nonfatal MI, nonfatal stroke, CV death, coronary revascularisation, or unstable angina requiring hospitalisation.5
In the REDUCE-IT trial, VAZKEPA was generally well tolerated with a safety profile evaluated over a median follow-up of 4.9 years in >4,000 patients5
Adverse reactions2
*Frequency categories were defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).2
†Dysgeusia describes the verbatim term: fishy taste.2
‡See SmPC: Description of adverse reactions.2
Contraindications, special warnings and precautions for use:
Contraindications to VAZKEPA include:2
- Hypersensitivity to the active substance or to any of the excipients, allergies to soya, peanut; and HFI.
Special warnings and precautions include:2
- Allergy to fish/shellfish, hepatic impairment, atrial fibrillation/flutter, bleeding.
Help redefine residual CV risk reduction with VAZKEPA5
In the REDUCE-IT trial, in adult statin-treated patients at high CV risk* with elevated TG, VAZKEPA:
- Demonstrated a statistically significant reduction in CV risk vs placebo, including CV death, beyond standard of care with statins alone5
- Was generally well tolerated5
- Keeps it simple: oral administration with no dose adjustments2
Intended for healthcare professionals in the UK only.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/
Adverse events should also be reported to Amarin Pharmaceuticals Ireland Limited:
Tel: 0800 0478 673 or e-mail: amarinconnect@amarincorp.eu
Prescribing information is available here
AAC, Accelerated Access Collaborative; ARR, absolute risk reduction; BP, blood pressure; CHD, coronary heart disease; CKD, chronic kidney disease; CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; ESC/EAS, European Society of Cardiology/European Atherosclerosis Society; FH, familial hypercholesterolaemia; HFI, hereditary fructose intolerance; HR, hazard ratio; LDL-C, low-density lipoprotein cholesterol; MACE, major adverse cardiovascular event; MI, myocardial infarction; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; NNT, number needed to treat; PAD, peripheral arterial disease; RRR, relative risk reduction; SCORE, Systematic Coronary Risk Estimation; TC, total cholesterol; TG, triglyceride.
- NHS. Accelerated Access Collaborative. Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD. Available at https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/National-Guidance-for-Lipid-Management-Prevention-Dec-2022.pdf. Accessed August 2023.
- VAZKEPA Summary of Product Characteristics.
- Visseren F, et al. Eur Heart J. 2021;42:3227–3337.
- NICE. Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides. Available at: https://www.nice.org.uk/guidance/ta805/chapter/1-Recommendations. Accessed August 2023.
- Bhatt DL, et al. N Engl J Med. 2019;380(1):11–22.