Update JULY 2021
The EPA capsules used in the EMT2 trial have now received approval from the MHRA (the drugs approvals agency in the UK) for use for prevention of cardiovascular (heart) disease in people with risk factors for heart disease (the medicine is called Vazkepa). As part of the licensing process, the MHRA wanted the Patient Information Leaflet to explicitly mention that the capsule coating contains small amounts of a substance called soya lecithin and that people with a known soya or peanut allergy should avoid the capsules
As a result of this new information the EMT2 trial team have now changed the trial patient information sheet to make sure that anyone with a known soya or peanut allergy, or a rare hereditary condition called hereditary fructose intolerance, does not join the trial. Please note that the capsules used in the trial have not changed and have always contained the same substances.
The trial team have also updated the information sheet to point out a small risk of irregular heart rate called atrial fibrillation that has recently been associated with EPA treatment and also a small increase in bleeding risk seen in a clinical trial of Vazkepa for those patients who already take anti-coagulant medication like warfarin. Neither of these new findings has altered how the trial is conducted.
People who are already in the trial and have been taking the capsules already without any allergy problem will need to read an updated information sheet and will be contacted via telephone by their local research team in order to provide written informed consent again. The local research team will be able to answer any questions that you may have about this news item or other aspects of the EMT2 trial.
