New drug to be available in Spain reduces ‘bad’ cholesterol levels by half with just two annual injections

A new drug that will soon be available in Spain can reportedly reduce high cholesterol levels by half with just two injections annually.

According to data from the National Statistics Institute (INE), cardiovascular diseases (CVD) are the leading cause of death in Spain.

Specifically, almost 120,000 people died from this cause in 2021. It was responsible for one in every four deaths, which equates to 26.4 per cent of the total number of people who died in Spain.

In most cases, there is a silent disease behind most of these cardiovascular deaths. Atherosclerotic cardiovascular disease (ASCVD) consists of the accumulation of lipids over time – mainly cholesterol – linked to low-density lipoproteins (c -LDL) in the inner lining of the arteries.

ASCVD reportedly accounts for two-thirds of the deaths from cardiovascular diseases. Patients who suffer from it are considered very high risk, given that they have already suffered a previous cardiovascular event.

Despite the widespread use of statins, 80 per cent of people with this profile do not reach the LDL (‘bad’ cholesterol) targets recommended by the guidelines.

That is a value below 55mg/dl and a 50 per cent reduction in the baseline level that they had when they suffered the cardiovascular event, which is known to be key to preventing heart attacks and strokes.

When will ‘inclisiran’ be available in Spain?

Starting next November 1, many of these patients will have access to a new medication called ‘inclisiran’. It promises to provide a powerful and sustained reduction in LDL-C of up to 54 per cent in patients with ASCVD.

This new molecule – trade name Leqvio, from Novartis – will be administered (and financed) in high and very high-risk patients as an addition to the maximum tolerated dose of statins.

The drug will be administered twice a year by means of a subcutaneous injection by the hands of a healthcare professional. A second injection is given three months after the first and, then, the treatment becomes chronic, with an injection every 6 months.

How does ‘inclisiran’ work in patients?

Its formulation and mechanism of action represent a qualitative leap with respect to the treatments available to date to reduce cholesterol.

That is because it is a small interfering RNA (siRNA) that inhibits the production of a molecule called PCSK9′. This is produced in the liver and its function is to reduce the uptake capacity of LDL cholesterol receptors.

José Luis Zamorano, head of the Cardiology Service at the Ramón y Cajal Hospital in Madrid explained: ‘RNA interference is a term that we specialists will have to start familiarising ourselves with from now on since the availability of this new treatment is going to change the way we approach cardiovascular diseases, as well as the way we treat them and patients’.

‘Until now, basically, what we had done was inhibit cholesterol formation with statins. Then PCSK9 inhibitors appeared and, as an evolution of these, what is coming now – inclisiran’, the expert added.

What are the advantages of this new drug?

In Zamorano’s opinion, the drug has three great advantages. ‘The first is its completely innovative mechanism of action, which allows it to achieve much higher efficacy than other therapeutic options’, he pointed out.

The specialist continued: ‘In previous studies with thousands of patients it has been shown to reduce LDL cholesterol by more than 50 per cent, and in a very easy way’.

‘The second is that these results are achieved with only two administrations per year. For the patient, this is great news since it reduces the chances of abandoning treatment to a minimum’, he added.

Zamorano concluded: ‘There is nothing worse than a chronic disease to lose adherence, and a pill a day is not the same as an injection twice a year. Furthermore, all this is achieved with a high safety profile’.

Which patients can benefit from this new drug?

In principle, ‘inclisiran’ is only designed and financed for patients considered high and very high-risk. ‘The first group includes people with documented cardiovascular disease (CVD), diabetics with three or more associated risk factors or long-term type 1 diabetes, with advanced chronic kidney disease (CKD), hypercholesterolemia with CVD or risk factors’.

‘The second is for people who, for example, smoke two packs of cigarettes a day – even if they do not have any other risk factors – diabetics with a higher risk factor, patients with CKD with stage III, familial hypercholesterolemia without CVD or risk factors, and a score of 5 to 10 per cent on the SCORE table’, explained the specialist.

On September 20, the Interministerial Commission on Drug Prices (CIPM) approved the treatment’s funding in adults with primary hypercholesterolaemia (familial and non-familial heterozygous) or mixed dyslipidaemia, as an addition to diet.

The medication will be used in combination with a statin or a statin and other lipid-lowering treatments in patients who fail to achieve LDL targets with the maximum dose of a statin. It can also be used as an alternative to statins in patients who are intolerant to those drugs, according to larazon.es this Tuesday, October 24.