As part of the fight against COVID-19, thousands of UK adults volunteered to take part in research trials, many for the first time. Thanks to them, we now have safe, proven treatments that have improved care and saved countless lives from COVID-19 around the world. Now that the immediate threat from COVID-19 has lessened, researchers say it is now time to return their attention to the major chronic diseases that are always with us and are responsible for the majority of deaths in the UK each year.
Lead Professor Louise Bowman from Oxford Population Health said: “Heart and circulatory diseases, for instance, kill around one in four people in the UK, and we know that cholesterol in the blood can play an important part in this. Consequently, we urgently need to find new treatments that can lower cholesterol effectively. Residents in Cumbria are being invited to take part in a new research study led by Oxford Population Health (part of the University of Oxford) which is investigating a promising new therapy.
“The study, called ORION-4, is investigating a treatment called inclisiran, which is given as an injection under the skin. ‘Although having a good diet and taking statins can help lower ‘bad’ cholesterol, sometimes these are not enough to lower a person’s risk of heart disease.
“So we are investigating whether a new injection could lower bad cholesterol more effectively. It also has the advantage that it only needs to be taken twice a year.”
The researchers are looking for 15,000 people aged over 55 years who have already had a heart attack, stroke, or operation to unblock or bypass an artery to their legs to take part in the study. These people are at greater risk of having heart and circulatory complications in the future, so could benefit significantly from treatments that lower cholesterol.
Local residents who may be eligible to take part will receive a letter from the NHS inviting them to participate. They will have been identified because their medical records show that they have had a heart attack, stroke, or procedure on their arteries in the past, and could benefit from cholesterol-lowering treatment.
Those who volunteer to take part will be asked to stay in the study for five years if possible. Each participant will be randomly allocated by a computer to receive either inclisiran or a placebo (dummy) treatment. To make the results as reliable as possible, neither the doctor nor the participants will know whether they get inclisiran or the placebo. Inclisiran has been approved as a safe treatment for use in the UK, and is already available to lower cholesterol in some people who have experienced a heart attack or stroke under certain circumstances.
Participants will be asked to attend three appointments in the first five months, and then once every six months after that. At each appointment, participants will have a blood sample taken and receive an injection of either inclisiran or the placebo treatment. Appointments can be taken locally at Cumberland Infirmary, Carlisle; Furness General Hospital; and West Cumberland Hospital.
Travel expenses to attend these appointments can be reimbursed. Participants’ GPs will be told that they are taking part in the study, but this will not affect any decisions about any other medical care they might need.
Professor Bowman added: “If you choose to take part, and the study finds that inclisiran is effective, you could be helping to prevent millions of people around the world from having heart attacks, strokes and bypass operations each year. But of course, taking part is completely voluntary.”
Leslie Rhodes, who is taking part in the study in Oxford, said: ‘So much medical research depends on volunteers, so taking part in the study seemed an obvious thing to do. And taking part is now so user-friendly, not a difficulty at all. So why not?’
Janet Morgan, another study participant in Cheltenham, added: ‘Taking part in the study is just so simple. Even easier than going to the dentist, and much more fun! The study clinic appointments just take 15-20 minutes, and the injections don’t hurt at all!’
You can find out more about the study on its website: https://www.orion4trial.org/homepage-uk
