Cardiovascular diseases are the main cause of death worldwide, according to the World Health Organization (WHO), which also highlights that a third of the deaths they cause are premature because they occur in people under 70 years of age. Two of the risk factors that most contribute to its appearance are hypertension and hypercholesterolemia, so preventing or controlling high levels of cholesterol and blood pressure is key to avoiding cardiovascular pathologies and their consequences.
Now, the new drug Inclisirán (Leqvio, by its commercial name), developed by Novartis, will be financed by the public health system for those patients with higher risk cardiovascular disease. It is expected to be available from November 1 and will be administered with two injections per year. Novartis notes that it is the “only cholesterol-lowering medication that is given to you by your doctor or other healthcare provider every six months after two initial doses.”
“LDL cholesterol is like plastic, we can’t get rid of it. Therefore, it is very important that we have mechanisms to be able to reduce circulating LDL cholesterol, because atherosclerosis is the cause,” explains José Luis Zamorano, Head of Cardiology at the Ramón y Cajal Hospital, in statements to Sexta.
In clinical trials Leqvio has been shown to reduce bad cholesterol levels by 50% and keep it low for six months
This new injectable treatment allows you to sustainably reduce LDL cholesterol by up to 54% in patients with cardiovascular disease with just two injections a year. “One of the advantages is that it is administered with a subcutaneous injection twice a year, that is, every 6 months, taking advantage of the fact that the patient comes for a medical visit,” adds Zamorano.
The president of the Vascular Risk and Cardiac Rehabilitation Association of the Spanish Society of Cardiology (SEC), Dr. Rosa Fernández Olmo, “inclisirán is an innovative treatment starting with the mechanism of action itself, since it will be the first time that RNA therapies – such as those used in COVID vaccines – be used in cardiovascular prevention, allowing us a novel approach to our patients with cardiovascular disease (CVD). Its dosage represents a revolution, with the potential to become our ally in the treatment of those patients who have previously suffered an event, thus obtaining an improvement in adherence without losing the opportunity to reinforce the need for patient follow-up in prevention programs. cardiovascular coordinated from the cardiac prevention and rehabilitation units with primary care,” according to their statements collected by IMMÉDICO.
What is the anticholesterol “vaccine” and for whom is it indicated?
Leqvio is also approved by the European Medicines Agency (EMA) which explains that “inclisiran, the active ingredient in Leqvio, interferes with RNA (genetic material) to limit the production of PCSK9, a protein that can increase LDL cholesterol levels. (‘bad’ cholesterol). By preventing the production of PCSK9, Leqvio helps reduce LDL cholesterol levels.”
The drug is indicated and funded in high- and very high-risk patients as an adjuvant to the maximum tolerated dose of statins and requires prescription by a physician. A healthcare professional will administer the drug twice a year via subcutaneous injection. The second is given three months after the first and, afterward, the treatment must be maintained with an injection every six months.
Leqvio is used along with diet and statins (cholesterol-lowering medications) in adults with high blood cholesterol levels, a condition known as primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein. (LDL-C) or “bad” cholesterol.
The pharmaceutical company has highlighted that in clinical trials it has been shown to reduce bad cholesterol levels by 50% and keep it low for six months. These results are based on a study in which 1,561 patients with atherosclerotic cardiovascular disease were taking a maximally tolerated statin with or without another cholesterol-lowering treatment in addition to Leqvio (781 patients) or a placebo (780 patients). Cholesterol levels were measured at the start of the study and compared to cholesterol levels 17 months later. 60% of the patients were 65 years or older. Leqvio was also studied in a similar clinical trial of 1,617 patients with similar results.
Regarding the real price of the treatment, in the United States it costs around 3,000 dollars per dose, while in Spain it is estimated that it will cost about 5,000 euros per patient per year, although it depends on the agreements reached by the Ministry of Health with the pharmaceutical company that markets it, which are not made public.
