In 2021, EMA published a favourable advisory report on the benefit-risk balance of the drug icosapent ethyl (EPA), branded as Vazkepa®, after which it was authorised for use in Europe. A large randomised placebo-controlled registration study found that this omega-3 fatty acid effectively reduced cardiovascular diseases and cardiovascular mortality rates among patients at high cardiovascular risk who have an elevated triglyceride level. Other studies, however, found no added value of EPA relative to placebo.
- In patients at high cardiovascular risk who have a normal LDL concentration and an elevated triglyceride concentration, 4 grams of icosapent ethyl (EPA) a day for 5 years reduces the absolute risk of cardiovascular diseases or cardiovascular mortality by 5% relative to mineral oil.
- It is not clear whether the effect found can be fully attributed to a favourable effect of EPA or is partly due to an unfavourable effect of the mineral oil used in the control group.
- Eighty percent of the users experience at least one adverse effect. One third of users develop gastrointestinal adverse effects.
- Based on the registration study, Ge-Bu advises against prescribing Vazkepa, in view of its doubtful effectiveness due to the use of mineral oil by the control group, as well as the non-representative inclusion criteria and the frequent adverse effects.
- Bang HO, Dyerberg J. Lipid metabolism and ischemic heart disease in Greenland Eskimos. In: Draper H, ed. Advances in Nutrition Research. New York, NY: Plenum Press; 1980:1-22
- Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al. REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792.
- Van den Bogert S. Omega-3-vetzuren niet beter dan placebo. Gebu. 2020;54(6-7):79-84.
- Abdelhamid AS, Brown TJ, Brainard JS, Biswas P, Thorpe GC, Moore HJ, et al. Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Feb 29;3(2):CD003177. doi: 10.1002/14651858.CD003177.pub5.
- Aung T, Halsey J, Kromhout D, Gerstein HC, Marchioli R, Tavazzi L, et al. Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77?917 Individuals. JAMA Cardiol. 2018 Mar 1;3(3):225-234. doi: 10.1001/jamacardio.2017.5205.
- Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, et al. Japan EPA lipid intervention study (JELIS) Investigators. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007 Mar 31;369(9567):1090-8. doi: 10.1016/S0140-6736(07)60527-3. Erratum in: Lancet. 2007 Jul 21;370(9583):220.
- LDL en triglyceriden. Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde (NVKC). Available from: https://nvkc.nl/zoek-een-test. Accessed 20-09 2021.
- Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031.
- Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). Am J Cardiol. 2011 Sep 1;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015.
- Zorgwijzer. Available from: https://www.zorgwijzer.nl/zorgwijzers/omega-3. Accessed 20-09 2021.
The literature refers to the Dutch text.