The 6-monthly injections of this drug have been “effective and sustained” in reducing cholesterol (LDL or bad cholesterol) in 54% of patients tested, according to data provided by Novartis, which is the laboratory that developed the drug.
So, when will Inclisiran be available in Spain? The answer is from November the 1st, in other words, it’s now available. It will be available on public health, so it won’t cost you an arm and a leg. Although you only require two injections a year, patients will still have to take their normal cholesterol tablets; i.e., statins.
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 vaccine against covid-19. In the case of the new drug, RNA inhibits the production of PCSK9, which is a protein that can increase bad cholesterol levels: when its circulation is reduced, cholesterol levels drop.
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. Furthermore, 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 decilitre 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 states 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.
Doctor Mostaza went on to say, “Thousands of people in Spain are going to benefit from this treatment, which has no contraindications or serious side effects.”
Anyway, cardiovascular diseases are the leading cause of death and cause one in four deaths in Spain. In 2021, 119,196 people died owing to these pathologies; i.e., 26.4% of the total deaths in the country. Furthermore, 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 are unaware of it.
Editorial comment: well if you see me with an extra arm coming out of one of my armpits…
(News/Noticias: Spain)