The formulation and dose of the omega-3 EPA (icosapent ethyl) that is being tested in the EMT2 trial was approved by NICE in July 2022 for prevention of heart attacks and strokes in patients who already have cardiovascular disease or diabetes, and are already taking a statin drug but still have high levels of triglycerides. It is marketed as Vazkepa by Amarin Corp, which supplies the active and placebo forms of icosapent ethyl for the EMT2 trial.
EPA CAPSULES USED IN EMT2 RECEIVE A LICENCE FOR USE FOR PREVENTION OF HEART DISEASE IN THE UK
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.
EMT2 trial update during the COVID-19 pandemic – Update December 2020
Thanks to the commitment of trial participants and research staff, the EMT2 trial remains open and is recruiting well. Some hospitals have needed to stop recruitment temporarily in the past few weeks due to pressure of COVID-19 work but follow-up of patients in the trial has continued unaffected. There is no suggestion that the active treatment in EMT2 (EPA) affects the body’s immune response to vaccines so we do not expect that participation in the EMT2 trial will affect any individual’s vaccination priority or response to it.
Sept 2020 – The trial has re-started really well since July with 20 patients recruited by seven sites. We are seeking ethical approval to allow telephone consent in case hospital visits before liver surgery are restricted in the coming months.
EMT2 trial in the COVID-19 recovery phase
Thanks to hard work by the research sites and the Clinical Trials Unit, trial participant follow-up and capsule delivery via courier continued largely unaffected during COVID-19 lockdown. Now comes the hard task of re-opening for recruitment as hospital services start to return to normal and research staff return to pre-COVID roles. We are working with research sites under NIHR ‘Framework for restart’ guidance to make this happen as fast as we can.
EMT2 News Update
May 2020 – the trial team is working with our hospital sites to re-start recruitment to the trial as soon as possible during the recovery phase after the disruption caused by the COVID-19 peak.