A new daily pill that dramatically lowered cholesterol in trials could soon be available for patients with particularly high levels of “bad” LDL cholesterol.
MK-0616 has been shown to lower cholesterol levels by more than 60 percent, depending on the dose.
The drug is a type of monoclonal antibody therapy — man-made proteins that bind to targets on the body. MK-0616 works by deactivating a protein in the liver called proprotein convertase subtilisin/kexin type 9 (PCSK9).
The liver usually processes two-thirds of LDL and removes it from the bloodstream. But the more of this protein a person produces, the more cholesterol remains in their blood — that’s because PCSK9 breaks down cholesterol receptors in liver cells that are responsible for removing cholesterol from the bloodstream.
A new daily pill that dramatically lowered cholesterol in trials could soon be available for patients with particularly high levels of “bad” LDL cholesterol. [File image]
MK-0616 has been shown to lower cholesterol levels by more than 60 percent, depending on the dose. In the picture: cholesterol in the blood vessels. [File image]
More than two in five people in England have high cholesterol, which puts them at risk for cardiovascular disease, which can lead to a heart attack or stroke.
According to NHS England, approximately 6.5 million adults in England are currently taking cholesterol-lowering drugs such as statins. These drugs reduce the amount of cholesterol made by the liver and help the liver remove cholesterol that is already in the blood.
‘Statins are the first-line treatment for high cholesterol,’ explains Chris Gale, professor of cardiovascular medicine and honorary consultant cardiologist at Leeds Teaching Hospitals NHS Trust.
“Statins lower cholesterol, but not always to the necessary level, and some patients cannot tolerate the high doses required to reach the recommended goal,” he says.
Results of a new study, published earlier this month in the Journal of the American College of Cardiology, showed that the new pill lowered LDL cholesterol in adults by 41.2 percent at the lowest dose (6 mg) and 60.9 percent. percent at the highest dose (30 mg) after eight weeks of therapy.
There were no reports of serious side effects and low rates of minor side effects – mostly flu-like symptoms, nausea, back pain and joint pain.
There are injectable forms of PCSK9 inhibitors (such as alirocumab and evolocumab), given every few weeks – these are approved for use by the NHS for patients whose cholesterol levels are still too high despite statins.
Another PCSK9 inhibitor, inclisiran, is given as an injection twice a year.
However, the new PCSK9-inhibiting drug can be taken as a daily pill, so it will likely overcome the drawbacks of the injectables, including skin reactions at the injection site and the fact that they are expensive.
The developer of MK-0616, the pharmaceutical company MSD, will begin further clinical trials in patients later this year, where the drug will be compared to the best available treatments – with the hope of being approved and launched in 2026.
Commenting on the research, Professor Gale said: ‘The results of this new drug trial are promising and, if the drug proves effective, will add to the options available to patients to control their cholesterol.
“MK-0616 appears to be very effective and has few side effects.”
‘The injectables are available on the NHS for patients who have not met their goals on statins alone, and they are effective, but adoption is slower than expected,’ says Professor Gale. “A daily pill may be preferable.”
While medications reduce cardiovascular risk, a healthy lifestyle is the cornerstone of high cholesterol treatment.
Priya Tew, a dietician from Southampton who works in the NHS, says: ‘Nutrition is always a great complement to medicine, and often making dietary changes can help improve the results of the medication.
‘This is not just about nutrition, but also about being more active, getting enough sleep and solutions for stress management.
“Strive for an optimal weight, avoid smoking, exercise regularly – and stick to a diet low in saturated fat and rich in fiber, fruits and vegetables, and oily fish.”