New pill for cholesterol when statins don't work

New pill for cholesterol when statins don’t work

A new daily pill which dramatically lowered cholesterol in trials could soon be available to patients with particularly high levels of ‘bad’ LDL cholesterol.

MK-0616 has been shown to reduce levels of cholesterol by more than 60 per cent — 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 de-activating a protein in the liver called proprotein convertase subtilisin/kexin type 9 (PCSK9).

The liver usually processes two-thirds of LDL, removing 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 which dramatically lowered cholesterol in trials could soon be available to patients with particularly high levels of ‘bad’ LDL cholesterol. [File image]

MK-0616 has been shown to reduce levels of cholesterol by more than 60 per cent — depending on the dose. Pictured: 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, leading to heart attack or stroke.

Beauty is pain

The downside of beauty routines. This week: Nail polish may hide sinister signs

If you develop a dark line on a toenail or fingernail, you might think it’s a bruise and cover it with polish, but in some cases it may be a type of skin cancer.

‘Subungual melanoma originates under the nail in the nail bed,’ explains Dr Suchitra Chinthapalli, a consultant dermatologist at The Harley Street Dermatology Clinic.

‘They often appear as a dark brown or black streak down the nail and most commonly affect the big toe or thumb.

‘We don’t know why they occur, but they are more common where there’s a family history.’

Not every mark on the nail is concerning, ‘but still, it’s important to get any new discolouration of your nails, or the skin around them, that doesn’t soon resolve, reviewed just in case,’ says Dr Chinthapalli.

Do this…

Maintain an active social life, as it could help you live longer, reports a new study in the Journal of Epidemiology & Community Health. Researchers analysed health data from 28,563 people with an average age of 89 — those who reported socialising frequently lived significantly longer; those who socialised daily benefited the most. ‘Socialising may mitigate the impact of chronic stressors,’ researchers said.

Do I need?

Gravity Blanket, £149, gravityblankets.co.uk

Claim: This cotton covering contains weighted beads that make it heavier than a standard duvet. The idea, says the maker, is that this gives the user the sensation of being hugged — which can increase levels of the sleep hormones serotonin and melatonin to encourage sleep. Each blanket is weighted according to a person’s height and weight to provide the right amount of pressure.

Expert verdict: ‘Humans can only rest properly if they feel safe and secure, and weighted blankets can help achieve a feeling of reduced anxiety and therefore promote better sleep,’ says independent sleep expert Dr Neil Stanley.

‘Some people like heavy bedding and others feel comfortable under lighter duvets, so whether this works is really down to preference.

‘There is no physiological mechanism that I am aware of whereby the use of a weighted blanket can lead to an increase in serotonin or melatonin.’

Around 6.5 million adults in England are currently taking cholesterol-lowering drugs such as statins, according to NHS England. These drugs work by reducing the amount of cholesterol made by the liver and helping it to remove cholesterol that is already in the blood.

‘Statins are the first-line treatment for high cholesterol,’ explains Chris Gale, a professor of cardiovascular medicine and an honorary consultant cardiologist at Leeds Teaching Hospitals NHS Trust.

‘Statins do lower cholesterol, but not always to the necessary level, and some patients may not be able to tolerate the high doses needed to reach the recommended target,’ he says.

Results of a new trial, 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 per cent at the lowest dose (6 mg) and 60.9 per cent 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 — typically flu-like symptoms, nausea, back pain and joint pain.

There are injectable forms of PCSK9 inhibitor drugs (such as alirocumab and evolocumab), which are given every few weeks — these are approved for use by the NHS for patients whose cholesterol levels are still too high despite being on statins.

Another PCSK9 inhibitor, inclisiran, is delivered as an injection twice a year.

However, the new PCSK9 inhibitor drug can be taken as a daily pill, so is likely to overcome downsides of the injectables, including skin reactions at the injection site and the fact that they are expensive.

The developer of MK-0616, pharmaceutical company MSD, is starting further clinical trials in patients later this year, where the drug will be compared with the best available treatments — with the hope of having it approved and launched in 2026.

Commenting on the research, Professor Gale said: ‘The results of this new drug trial are very promising and, if the drug proves to be effective, will add to the options available to patients to help control their cholesterol.

‘MK-0616 seems to be very effective and has a low rate of side-effects.’

‘The injectables are available on the NHS for patients who have not reached their goals on statins alone, and they are effective but the take-up has been slower than expected,’ says Professor Gale. ‘A daily pill may be preferable.’

Although drugs reduce cardiovascular risk, the cornerstone of treatment of high cholesterol is a healthy lifestyle.

Priya Tew, a dietitian based in Southampton who works in the NHS, says: ‘Nutrition is always a great complement to medications, and often making dietary changes can help improve the results of the medication.

‘This is not just about nutrition, but also being more active, getting adequate sleep and having stress management solutions.

‘Aim to reach an optimum weight, avoid smoking, exercise regularly — and stick to a diet low in saturated fat and rich in fibre, fruit and vegetables and oily fish.’

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