ORION-4 Participant Newsletter, spring 2024
Over 7 ½ million people in the UK live with heart and circulatory diseases (known as cardiovascular disease).
ORION-4 is a clinical trial to find out if inclisiran, a new treatment to lower bad cholesterol, can help to protect them. Your contribution to this research is very important - a big thank you for your support.
This is an update on the trial progress that was issued to participants by post in spring 2024.
orion-4 completes recruitment with 16,124 volunteers
ORION-4 has successfully completed enrollment with 16,124 volunteers joining the trial, including 13,190 in the UK. We are very grateful to everyone who has joined the study and the ORION-4 research staff in over 100 hospitals, GP surgeries and other sites across the UK for their hard work in making this happen. To reliably find out if treatments can help protect patients from serious health problems such as heart attacks and strokes, clinical trials need to be very large. Recruiting enough volunteers to join a trial can often be a challenge. We are delighted that ORION-4 has reached this major milestone.
Impact of COVID-19 on the ORION-4 trial
The COVID-19 pandemic had a major impact on research across the UK. For ORION-4, we had to put a hold on enrolling new participants for over a year and some participants received their injections at home while the ORION-4 clinics were closed to in-person visits. We are very grateful to the trial participants for continuing to support the study despite this disruption to the study clinics, and to the ORION-4 research staff in local hospitals and GP surgeries who were under a lot of pressure during this time.
In October 2021, ORION-4 was able to restart inviting new participants to join the study in the UK and, thanks to the continued support from participants and the commitment of the local ORION-4 research teams, we were able to enroll the number of participants needed, despite the impact of COVID-19.
ORION-4 researchers at the University of Oxford also helped to support the RECOVERY trial, the UK’s national study for assessing treatments for patients admitted to hospital with COVID-19.
ORION-4 is on track to deliver important results, but will go on longer than planned
When we planned the ORION-4 study, we estimated that it would take 18-24 months to enroll the number of participants needed and that, on average, participants would be asked to continue the six-monthly injections and provide information about their health at ORION-4 follow-up visits – the ‘scheduled treatment period’ - for about five years. For participants who joined the study at the beginning in 2019, the scheduled treatment period would be slightly longer than five years and for the last participants to join the study, it would be slightly shorter.
Because of the impact of the COVID-19 pandemic, it took longer than planned to enroll the number of participants needed. This means that the scheduled treatment period will need to continue longer than we originally thought – we estimate until 2026. Participants are free to stop all or any part of the study at any time if they choose. However, in order to make sure that the study produces reliable results, it is important that as many participants as possible regularly attend the ORION-4 clinics and receive the study injections. If you would like to discuss this or any other aspect of the study, please contact the ORION-4 coordinating centre (contact details are in the banner of this website).
Inclisiran now available on the NHS for some patients with cardiovascular disease
I had a heart attack back in 2007, and my doctors only know how to treat me now, with statins and aspirin and the like, because 20 years ago people like me joined earlier studies. So I think it’s my duty to take part in trials like this, and without volunteers nothing will get better.
-David Hughes, study participant
In October 2021, inclisiran was recommended by the National Institute for Health and Care Excellence for some patients with heart and circulatory disease (cardiovascular disease) who have high levels of bad cholesterol.
At the moment, the treatment is not available widely in the UK as the NHS is still developing the processes for patients to receive it.
If the ORION-4 trial results show that inclisiran safely helps to protect patients against heart attacks, strokes and similar conditions, we hope that the treatment will become widely available to patients with cardiovascular disease.
Scotland's big contribution to orion-4
Despite having a population of only 5.4 million, Scotland has made a big contribution to ORION-4. It took a bit of time to set up all the systems needed to invite patients to join the study in Scotland but, since recruitment to the study opened in Scotland in November 2021, over 1,100 participants have joined the study in our Scottish sites.
Lowering cholesterol is a major priority for patients with cardiovascular disease and we are really excited to be supporting this important research study. Over 280 volunteers have joined ORION-4, in the Dundee area, which is fantastic.
- Professor Isla Mackenzie, ORION-4 Local Lead Investigator Dundee
