A clinical trial, coordinated by researchers from Queen Mary University of London, is currently recruiting patients in London to see whether a new cholesterol-lowering drug could save lives in people who are intolerant to statins.
Cardiovascular disease is the number one cause of death globally. High cholesterol is a major risk factor, and statins have been crucial in lowering cholesterol levels in many patients. However, some patients are intolerant to statins, causing symptoms such as muscle ache and pains, and need new therapeutic options to lower their cholesterol.
Currently, there are very few approved drugs that demonstrate cardiovascular risk reduction in these patients and these drugs are very expensive and not available to the majority of patients.
The CLEAR Outcomes Study is recruiting 14,000 patients worldwide from 1000 sites located in over 30 countries, including London, to see if a new drug called Bempedoic acid reduces the risk of heart attacks and strokes in statin-intolerant patients who are at high risk for cardiovascular disease.
Mary Salim, 72, a retired nurse from Stamford Hill, North London, is currently enrolled in the study, and said: “I was put on statins after I had heart attack 15 years ago. Unfortunately, after three years of taking statins, I developed muscle pain and realised I couldn’t tolerate them. I’ve tried five or six varieties of statins over the years, and I just don’t get on with them.
“There are obviously lots of questions and controversy around statins. The more that they’re studied, and substitutes for them are investigated, the clearer the picture will be. Statins may well suit lots of people, while other people will need alternative medication.
“Being enrolled on this study is fantastic. There aren’t any great advances in medicine without clinical trials, so I really wanted to give something back and help out. It’s also good to get more regular health checks than you would receive under normal health care.”
The team is currently aiming to recruit participants in the London area. Being a participant involves taking the study medication (either bempedoic acid or a placebo) daily for 2-5 years, with regular health checks and tests over the course of the study to monitor cholesterol levels and other health factors. Participants are looked after by an experienced clinical team, and have all travel costs reimbursed.
Lead researcher Dr Manish Saxena from Queen Mary's William Harvey Research Institute said: “Statins are effective in lowering bad cholesterol in the body and prevent heart attacks and strokes. Unfortunately, a small number of patients are unable to tolerate statins due to side effects such as muscle aches and pains.
“This new drug called Bempedoic Acid is well-tolerated in these patients and previous studies have shown it to be safe and efficacious in lowering bad cholesterol. This long term study is investigating its effect on preventing heart attacks and strokes in high-risk patients. In the future, Bempedoic Acid could be a safe alternative treatment option for lowering cholesterol in patients who do not tolerate statins.”
Both statins and bempedoic acid lower cholesterol by inhibiting the creation of cholesterol in the liver. Bempedoic acid will only work when it comes into contact with a specific enzyme in the body. This enzyme is only found in the liver, where cholesterol is made, and is not found in the muscles in the body. Therefore, bempedoic acid may not cause muscle-related side effects that statins do.
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