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Reduction of cardiovascular risk with fish oil (Vazkepa)


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.

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The literature refers to the Dutch text.

Authors

  • Sander van den Bogert, dr, pharmacist