The injectable cholesterol medication arrives in Spain. The Ministry of Health has approved the financing of the drug inclisiran (trade name Leqvio), which provides an “effective and sustained” reduction in the level of cholesterol linked to low-intensity lipoproteins (LDL or bad cholesterol) in 54% of patients. with atherosclerotic cardiovascular disease, according to data provided by Novartis, the laboratory that developed the drug. Inclisiran will be available from November 1 and will be administered in two doses per year.
The technology used in the development of the drug is RNA, which for the first time will be applied to cardiovascular patients. The mechanism is similar to that used in the injectable drug against covid-19, whose promoters have just won the Nobel Prize in Medicine. In this case, the RNA inhibits the production of PCSK9, a protein that can increase bad cholesterol levels: when its circulation is reduced, the cholesterol level drops.
The injections of inclisiran will be subcutaneous and every six months, although patients must continue taking anti-cholesterol pills (statins) for the treatment to be more effective. According to the clinical trials developed by Novartis (called ORION-3), inclisiran achieved, in the 17 months after its administration, “sustained reductions in LDL-C cholesterol, PCSK9 and other lipoproteins” with “good tolerance” of patients “and a good safety profile.”
According to the European Medicines Agency (EMA), which approved inclisiran in 2020, patients with primary hypercholesterolemia or mixed dyslipidemia (diseases that cause high levels of lipids, including cholesterol, in the blood) may receive this drug. ). Additionally, it should be used with a low-fat diet.
«The Ministry of Health finances it exclusively for patients with familial hypercholesterolemia in whom oral treatment is not sufficient and who are above 100 milligrams per deciliter of blood or in patients who have suffered a heart attack or stroke when, despite taking oral treatments, they are still above that figure,” explains Dr. José María Mostaza, head of the Internal Medicine section at the La Paz Hospital in Madrid. However, Mostaza explains that the medication should be extended to other “high-risk” patients, who, for example, have 90 bad cholesterol and must lower it to 55, the amount set as an adequate level in these patients.
Inclisiran “improves patient comfort and increases adherence to treatment, which is usually one of the problems we encounter with cholesterol. Since the patient doesn’t hurt at all, he stops taking the drugs. Now there will be two injections a year, although without ever abandoning oral treatment,” adds Mostaza. “Thousands of people in Spain are going to benefit from this treatment, which has no contraindications or serious side effects,” says the internist, since the most frequent side effects of Leqvio (which can affect up to one in 10 people) are mild reactions such as pain, redness, and rash at the injection site.
Atherosclerosis is a common condition that appears when a substance called plaque accumulates inside the arteries and atherosclerotic cardiovascular disease is a “chronic, generalized and progressive pathology that affects the arteries, thickening and hardening their interior walls, until it causes a cardiovascular event,” according to the Spanish Society of Cardiology. Lipids, especially cholesterol, accumulate on the inner walls of the arteries, and the unexpected rupture of the atherosclerotic plaque can cause a heart attack, angina or a stroke.
In Spain, cardiovascular diseases are the leading cause of death and cause one in four deaths. In 2021, 119,196 people died due to these pathologies, 26.4% of the total deaths in the country. Cardiovascular diseases are also the leading cause of hospitalization (12.9%) in 2021, with 582,446 admissions to public hospitals. According to the Spanish Heart Foundation (FEC), more than half of the adult population in Spain (50.5%) has high cholesterol levels, although the majority does not know it.
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