Clinical trial run in South West shows gout drug does not improve heart disease

The results of a clinical trial which saw 325 people from across the South West volunteer to take part has shown a gout drug does not improve coronary heart disease.

The ALL-HEART study, published in the Lancet journal, found the drug allopurinol failed to prevent adverse cardiovascular outcomes in patients with heart disease without gout.

Experts at the University of Dundee and NHS Tayside, led the study over nine years. They analysed results from 5,721 patients across the UK over a seven-year period.

325 patients from 15 GP practices across Devon and Somerset volunteered to take part in the study regionally.

Taking part in research can have some additional benefits and they are not always linked to the intended outcome. Despite the drug not being shown to reduce heart attacks, in one South West participant it appeared to have treated previously unrecognised gout. Colin Wells, from Exmouth, signed up to the study thanks to doctors at Exmouth’s Claremont Medical Practice.

As Colin explains, participating in the study has led to a substantial improvement in his quality of life, despite the outcome not having had a direct impact on his heart disease. “Prior to the study, for many years I had experienced problems with my right knee. It was problematic and painful when cycling, walking, doing gym exercise etc, and I’d been using straps on a fairly regular basis. I’d been to the doctor a couple of times about it and been put on codeine phosphate – co-codamol - as and when required. I got a hundred at a time and they would last about 18 months. Once I’d started taking them, I used to go out on my bike and my knee would be a little bit ‘catchy’, but to a lesser extent.

“Anyway, about 5 or 6 weeks after starting the trial, we went to visit my wife’s sister in Austria and while I was there they said, we’ve laid on a walk for you, up in the mountains. I agreed to try it, but I took my straps just in case. We went out and walked for several hours and I climbed 5 or 600 metres, absolutely no problems, I just couldn’t believe it. For the first time in over 20 years I did not experience any discomfort whatsoever! I can honestly say that even in the past five years my knees have never bothered me again. I don’t even know where the straps are now, they’re in a drawer somewhere.

“Is my experience a pure coincidence? Or was it a benefit of the allopurinol? I’m convinced in my own mind that it was.”

Colin’s doctors agreed and he is continuing to take the drug outside the study, an ongoing benefit of his participation in addition to the hugely valuable contribution he has made to improving care and treatments for others in future.

Dr Lisa Gibbons, Primary Care Lead for the Clinical Research Network South West Peninsula, said: “It is really good to discover the results of this study and many thanks to the people in the South West who took part. These 'negative' results are so important. It is really common for studies to suggest adding in more and more drugs to help reduce risks and often patients with heart conditions are on multiple medications.

“New drugs could theoretically reduce their heart attack risk but add another medication for them to take. It is absolutely critical to understand the value of new medication and this study has shown that although there is a theoretical reason why it may reduce heart attack it actually does not so there is no need for extra medication.”

Previous studies showed allopurinol displayed cardiovascular benefits for patients with angina or coronary artery disease. This included increased exercise time and reduced chest pain as results of taking the drug.

The study group consisted of over 60s with ischaemic heart disease (also referred to as coronary heart disease), but no history of gout. Half received a daily dose of allopurinol and the other received regular care.

Experts found there was no evidence of different health outcomes between patients in the two groups. This ruled out allopurinol as a beneficial form of medication for these patients. The findings also revealed no difference between the groups in the secondary study outcomes. This included cardiovascular death, hospitalisation for heart failure, and all cardiovascular hospitalisations.

The 15 GP practices which recruited patients into the study regionally were:

1.    Bovey Tracey and Chudleigh Practice
2.    Claremont Medical Practice, Exmouth
3.    Rolle Medical Partnership, Exmouth
4.    Honiton Surgery
5.    Cricketfield Surgery, Newton Abbot
6.    Axbridge Surgery, Somerset
7.    Chaddlewood Medical Practice, Plymouth
8.    Ashburton Surgery
9.    Cranleigh Gardens Medical Centre, Somerset
10.    Yealm Medical Centre
11.    Kingskerswell and Ipplepen Medical Practice
12.    Glastonbury Surgery
13.    Coleridge Medical Centre, Devon
14.    Brunel Medical Practice, Torquay
15.    Vine Surgery Partnership, Somerset