Date: 17 May 2017
A retired P.E teacher who suffered three heart attacks has urged people to take part in NHS research after participating in a clinical trial into a cholesterol-lowering drug.
Bob Mason, of Aston Clinton, Buckinghamshire, took part in a five-year trial for injectable drug Alirocumab.
Now the 70-year-old is taking the drug every two weeks after research showed it was an effective way of lowering cholesterol and was approved for use in the NHS. It means he no longer has to take statins, which were having a negative impact on his health.
Mr Mason is today urging others to ask their doctor about taking part in trials or get involved when asked by the NHS as researchers mark International Clinical Trials Day (May 20).
He said: “The chance to contribute in a clinical trial was in itself therapeutic, a real insight into the workings of a research department, that was very well organised, positive and above all, medically accurate. I consider myself very fortunate.”
Mr Mason had three heart attacks in 2013 and 2014 which resulted in six stents being fitted to his heart to prop open the muscle’s arteries.
The ODYSSEY Outcomes trial involved patients being asked to inject a placebo dummy drug or the actual drug every two weeks, so the two could be compared by researchers.
The worldwide study was to see if Alirocumab can prevent further cardiovascular events such as heart attacks or strokes.
Patients were also given statins, the current best treatment for high cholersterol, although Mr Mason suffered painful side effects from these.
One of the main risk factors for developing coronary heart disease is high levels of cholesterol in the blood, in particular high levels of a type of cholesterol called LDL-cholesterol (bad cholesterol).
Alirocumab binds together a substance called PCSK9 which is secreted from the liver into the blood stream and increases LDL-cholesterol levels in the blood.
By binding together PCSK9 the drug blocks its interactions with LDL receptors, therefore reducing bad cholesterol levels.
Mr Mason took part for a year from 2014 to 2015 and is still providing blood and urine samples as part of the trial’s follow-up process at Wycombe Hospital, High Wycombe.
To ensure the trial runs smoothly he is not allowed to know if he took the dummy or real drug.
But now Mr Mason is taking the drug as part of his routine care after it was approved for use in the NHS by The National Institute for Health and Care Excellence (NICE).
He said: “The drug has definitely lowered my bad cholesterol which is in itself a good thing for a person like me.”
He said the regular medical tests given as part of the study left him feeling assured about his health: “When you suffer a heart attack, and repeat it, your confidence fades, what was your invincible persona fades and the temple that once carried you round with belief is weakened, indeed vulnerable.
“Thankfully the after care and therapy offered to myself was exemplary, a series of well organised physical sessions, building back an eagerness to keep exercising, controlling diet, and generally feeling good about the recovery.”
And he said he was grateful that the years of research into the drug had paid off now it was in the NHS, given the negative impact on his health from taking statins.
“The statins created an awful aching feeling, like you are being punched, it feels like you have fallen over, you feel bruised, your joints swell and your muscle tone drifts away.”
His cholesterol score three-and-a-half-years ago was 10.2 millimoles per litre of blood and is now four. A healthy adult’s cholesterol should be less than five and less than four for those at high risk.
The drug was provided by pharmaceutical company Sanofi and trialled at Buckinghamshire Healthcare NHS Trust, which runs Wycombe Hospital, with staffing support from the NIHR Clinical Research Network Thames Valley and South Midlands (TVSM CRN).
The CRN is part of a national network of Clinical Research Network centres run by the Department of Health-funded National Institute for Health Research (NIHR).
The TVSM CRN provided a research nurse to recruit patients and the hospital’s cardiology department now has two research nurses and three research practitioners partially funded from the CRN to work on trials. Over the last six years the department has opened about 30 cardiology clinical trials.
Principal Investigator Dr Piers Clifford said: “Mr Mason, one of our star patients, really needed a new cholesterol lowering option as he had already suffered three attacks and couldn't tolerate statins. His participation in the trial will hopefully have helped him as well as contributed to our scientific knowledge of how these drugs work for patients.”
He added: “Cardiac research is crucial in delivering evidence of the efficacy of new drugs, technology and medical pathways.
“We are very proud to have delivered over 40 randomised trials in the last four years. These have given patients access to treatments which would otherwise not have been available to them.
“The ODYSSEY Outcomes study is important as it will allow us to find out whether a new breed of cholesterol lowering agents will reduce cardiovascular events in patients who have already had a heart attack and who struggle to take statins.”
International Clinical Trials Day is held every 20 May to celebrate the anniversary of the first clinical trial by James Lind in 1747 into the causes of scurvy on board the HMS Salisbury.
Participating in health research helps develop new treatments, improve the NHS and save lives.
The NHS supports research through asking patients if they wish to take part in trials and healthy people if they also wish to take part so results can be compared to those with a medical condition.
Patients are also encouraged to ask their doctor about research opportunities and view trials seeking volunteers at The UK Clinical Trials Gateway at www.ukctg.nihr.ac.uk.