HEALTHPLAN MAGAZINE

Spain’s Ministry of Health has given the green light to fund a new groundbreaking treatment for high cholesterol.

The drug which is called inclisiran and also known as Leqvio has been shown to significantly reduce high cholesterol levels in patients with atherosclerotic cardiovascular disease.

According to Novartis, the company behind the drug, it effectively lowers LDL cholesterol (commonly referred to as bad cholesterol) in 54% of patients. Starting from November 1st, inclisiran will be administered to patients in two doses each year.

Inclisiran utilises RNA technology, which is being applied to cardiovascular patients for the first time. The mechanism is similar to the one used in the development of COVID-19 vaccines. This RNA technology inhibits the production of a protein called PCSK9, which is known to raise bad cholesterol levels. When the production of PCSK9 is reduced, cholesterol levels drop.

Inclisiran will be administered through subcutaneous injections every six months. However, patients will still need to continue taking their cholesterol medication (statins) in order to see the best results.

Clinical trials conducted by Novartis (referred to as ORION-8 trials) have shown that inclisiran can sustainably reduce bad cholesterol (LDL-C cholesterol), PCSK9, and other lipoproteins over a period of 17 months. Furthermore, patients have reported good tolerance when taking inclisiran with Novartis claiming that the medication has a “good safety profile”.

“These long-term results show that twice-yearly inclisiran, when used in addition to statin therapy, provides consistent LDL-C reduction in patients with ASCVD, and those at increased risk of developing cardiovascular disease,” said Norman Lepor, M.D., a Los Angeles based cardiologist and Director of the National Heart Institute.

“While LDL-C is one of the most readily modifiable risk factors for heart disease, many patients do not reach their recommended LDL-C target through use of statin therapy alone. The demonstrated long-term efficacy of inclisiran indicates that after administration by a health care provider (HCP), both patient and HCP can be confident that a dose has been received for six months.”

The European Medicines Agency (EMA) approved inclisiran in 2020 and noted that common side effects, affecting up to 1 in 10 people, include mild reactions like pain, redness, and rash at the injection site.

Atherosclerosis, a common condition, occurs when plaque builds up in the arteries. Atherosclerotic cardiovascular disease is a chronic and progressive condition that affects the arteries, causing them to thicken and harden. This can lead to cardiovascular events like heart attacks, angina, or strokes.

“The ORION-8 results affirm the benefits of Leqvio in helping patients achieve sustained LDL-C reduction, which is important as cumulative exposure to LDL-C leads to the growth of plaque in the arteries and an increased risk of cardiovascular events,” said David Soergel, M.D., Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis.

What are the consequences of having high cholesterol?

Atherosclerotic cardiovascular disease, often referred to as ASCVD, encompasses a range of conditions stemming from the formation and expansion of plaques within the inner walls of arteries. These plaques are primarily composed of low-density lipoprotein cholesterol (LDL-C), which accumulates gradually. The accumulation of LDL-C is directly linked to the growth of arterial plaques, which, in turn, heightens the risk of experiencing cardiovascular events like heart attacks or strokes.

ASCVD is responsible for a staggering 85% of all cardiovascular disease-related deaths and stands as the primary cause of mortality in the European Union. In the United States, it outstrips the burden of any other chronic disease.

How many of Spain’s citizens are affected by high cholesterol and cardiovascular disease?

Cardiovascular diseases are the leading cause of death in the European Union.

According to data published by the European Commission, one in three deaths in 2020 were attributed to cardiovascular diseases.

In Spain, cardiovascular diseases are the leading cause of death, responsible for around one in four fatalities. In 2020, 24.2% of all deaths in the country, or 119,449 people, were attributed to these diseases.

According to the Spanish Heart Foundation (Revista Española de Cardiología), more than half of Spain's adult population (50.5%) has high cholesterol levels, with many of them unaware of their condition.

A straightforward blood test at the doctor's office is all that's needed to determine whether a patient has elevated cholesterol levels.

Lifestyle changes can also reduce LDL cholesterol

So, what are the ways to decrease our LDL cholesterol levels?

The NHS in the UK provides several suggestions for lowering bad cholesterol, which can enhance the effectiveness of medications and encourage a healthier way of life.

1. Watch Your Food

- Reduce fatty foods, especially those with saturated fats.
- Opt for healthier fats like unsaturated fats.
- Check food labels for fat types.
- Eat more: oily fish, brown rice, whole grain bread, nuts, fruits, and veggies.
- Eat less: meat pies, sausages, butter, cream, cakes, and foods with coconut or palm oil.

2. Get Active

- Aim for at least 150 minutes of exercise each week.
- Try brisk walking, swimming, or cycling.
- Find exercises you enjoy to stay motivated.

3. Quit Smoking

- Smoking raises cholesterol and heart risks.
- Get support from your GP or the NHS Stop Smoking Service.

4. Cut Down on Alcohol

- Stick to 14 units or less per week.
- Include alcohol-free days.
- Avoid binge drinking.
- Consult your GP if you need help.