New pill for cholesterol when statins don’t work

A new daily pill that has been shown in studies to drastically lower cholesterol levels may 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 therapy that uses monoclonal antibodies – artificial proteins that bind to targets in the body. MK-0616 works by deactivating a protein in the liver called proprotein convertase subtilisin/kexin type 9 (PCSK9).

The liver normally processes two-thirds of the LDL and removes it from the bloodstream. But the more of this protein a person produces, the more cholesterol remains in their blood – this is because PCSK9 breaks down cholesterol receptors in liver cells, which are responsible for removing cholesterol from the bloodstream.

MK-0616 has been shown to lower cholesterol levels by more than 60 percent, depending on the dose. In the photo: Cholesterol in the blood vessels. [File image]

More than two in five people in England have high cholesterol, which puts them at risk of cardiovascular disease which can lead to a heart attack or stroke.

Around 6.5 million adults in England are currently taking cholesterol-lowering drugs such as statins, according to NHS England. These drugs reduce the amount of cholesterol produced 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 levels, and some patients cannot tolerate the high doses needed to reach the recommended goal,” he says.

The results of a new study published earlier this month in the Journal of the American College of Cardiology showed that the new pill reduced LDL cholesterol in adults by 41.2 percent at the lowest dose (6 mg) and with 60, 9 percent at the highest dose decreased (30 mg) after eight weeks of therapy.

There were no reports of serious side effects and low rates of minor side effects – mainly flu-like symptoms, nausea, back pain and joint pain.

There are injectable forms of PCSK9 inhibitors (such as alirocumab and evolocumab) that are given every few weeks – these are approved 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 likely overcomes the disadvantages of injectable drugs, 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, comparing the drug with the best available treatments, with hopes of approval and commercial launch in 2026.

Commenting on the research, Professor Gale said: “The results of this new drug trial are encouraging and, if the drug proves effective, it will expand the options patients have to manage their cholesterol levels.

“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 uptake has been slower than expected,” says Professor Gale. “A daily pill may be preferable.”

While medication reduces cardiovascular risk, a healthy lifestyle is the cornerstone of treating high cholesterol.

Priya Tew, a dietician from Southampton who works in the NHS, says: “Diet is always a good adjunct to medicine and often dietary changes can help improve the results of the medicine.

“It’s not just about nutrition, it’s also about being more active, getting enough sleep and finding solutions to deal with stress.

“Aim for optimal weight, avoid smoking, exercise regularly — and eat a diet low in saturated fat and high in fiber, fruits and vegetables, and oily fish.”