Inclisiran: side effects of anti cholesterol drug being offered on the NHS - who are manufacturers Novartis?

Hundreds of thousands of people are to be offered a cholesterol-lowering drug on the NHS, with estimates predicting it could save 30,000 lives within the next decade.

Inclisiran has been described as a potential “game-changer” and it is hoped it could prevent 55,000 heart attacks and strokes, and save tens of thousands of people from an early death.

Inclisiran will be given as an injection by nurses in GP surgeries across England, with an initial dose followed by another three months later and then twice a year thereafter.

Here is everything you need to know about it.

Who will be given the jab?

The treatment will be given to people with high cholesterol or mixed dyslipidemia – abnormally high levels of fats in their blood – who have already had a heart attack or stroke, under draft final guidance by the National Institute for Health and Care Excellence (Nice).

NHS England said the drug will be rolled out at an unprecedented scale after the health service and drugmakers Novartis struck a deal that enables use of inclisiran at a cost-effective price.

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, one of the largest pharmaceutical companies in the world.

The “population health agreement” deal could eventually see nearly half a million people benefit from the treatment, helping to prevent 55,000 heart attacks and strokes and potentially saving 30,000 lives in the next decade.

More than two in five people in England have high cholesterol, which puts them at significant risk of developing heart disease, NHS England said, adding that around 6.5 million adults were currently taking lipid-lowering drugs such as statins.

Inclisiran can be used alongside statins, adding to the options available to patients to help control their cholesterol levels.

Nice said its recommendation of the drug applies to England and Wales, and inclisiran is also recommended for use in research trials of people who have never had a cardiovascular event.

How does it work?

The drug is the first of a new type of cholesterol-lowering treatment that uses RNA interference (RNAi) to help the liver remove harmful cholesterol from the blood.

Inclisiran lowers the level of a type of fatty substance called LDL-C found in the blood; high levels of LDL-C makes people more likely to suffer a heart attack or stroke.

Nice said clinical trial evidence shows that it might lower levels when other treatments have not reduced them enough.

The health watchdog said while there is no long-term evidence yet on inclisiran’s effect on cardiovascular outcomes, it is considered cost-effective in people who have previously had a cardiovascular event such as a heart attack or stroke and whose cholesterol levels stayed high even after being given other therapies.

What are the benefits?

Heart disease accounts for around a quarter of deaths in England each year, NHS England said.

NHS chief executive Amanda Pritchard said: “The NHS is committed to using cutting-edge treatments to save and improve patients’ lives.

“Heart disease is still one of the major killer conditions so it is fantastic that we now have such an effective and convenient treatment for those living with dangerously high cholesterol levels.

“This world-leading deal for the rollout of inclisiran will save lives and enable hundreds of thousands of people to benefit from this revolutionary treatment, while also being fair to taxpayers.”

Professor Sir Nilesh Samani, medical director at the British Heart Foundation described the drug’s approval as “good news for heart patients” and suggested further research could see it rolled out to a broader group.

He said: “More research is needed to confirm the full extent of its benefits, but I anticipate that in the future it will also be approved to lower cholesterol for a much wider group of people to prevent them from having a heart attack or stroke in the first place.”

What are the side effects?

Prior research into the drug suggests serious reactions to inclisiran are extremely rare.

Mild side effects experienced by those in trials include symptoms that you would expect from most drugs given via an injection.

“Adverse reactions” included cough, musculoskeletal pain, cold symptoms, headache, back pain, and diarrhoea, and were present in less than two per cent of patients taking part in the trial.

How to lower cholesterol without medication

Lifestyle factors play a big part. Smoking, an unhealthy diet and a lack of physical activity can lead to higher levels of bad cholesterol.

Experts suggest cutting down on the amount of fatty food you eat (so opt for leaner cuts of meat, grill rather than fry and limit your biscuit and cake intake), including more fruit and veg in your diet, taking regular exercise and giving up smoking.

Add some of these to your daily diet to help lower your cholesterol, suggests the cholesterol charity Heart UK:

- Soya foods: Naturally low in saturated fat, studies show that as little as 15g of soya protein a day, found in things like edamame beans, tofu and soya milk, can lower your cholesterol by around 6 per cent.

- Nuts: A handful of nuts (30-35g) a day could lower your cholesterol by an average of 5 per cent.

- Oats and barley: These grains are rich in beta glucan, a form of soluble fibre, which prevents cholesterol from being absorbed in the intestines.

- Seeds: These are a natural source of cholesterol-lowering plant sterols and stanols, which are also found in fruits and vegetables, vegetable oils, nuts and whole grains.

- Fruit and vegetables: Low in saturated fat, they’re also a source of cholesterol-lowering soluble fibres. Try to eat at least one pulse (beans, peas, lentils) each day, as well as sweet potato, aubergine, okra, broccoli, apples, strawberry and prunes, also rich sources of soluble fibre.

- Unsaturated fats: We need to avoid saturated fat where possible, staying below 20g per day for women and 30g for men. But it’s important to replace it with unsaturated fats, which can be found in vegetable, nut and seed oils, avocado, oily fish and nuts.

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