Wednesday, 25 October 2023, 13:22
A revolutionary cholesterol treatment has arrived in Spain. The national Ministry of Health has approved funding for the drug inclisiran (trade name Leqvio), which provides an "effective and sustained" reduction in the level of low-density lipoprotein cholesterol (LDL or bad cholesterol) in 54% of patients with atherosclerotic cardiovascular disease, according to data provided by Novartis, the laboratory that has developed the drug. Inclisirane will be available from 1 November 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 Covid-19 vaccine, whose developers have just won the Nobel Prize for Medicine. In this case, the RNA inhibits the production of PCSK9, a protein that can increase levels of bad cholesterol: when its circulation is reduced, cholesterol levels fall.
Inclisiran injections will be subcutaneous and every six months, although patients must continue to take their cholesterol tablets (statins) for the treatment to be most effective.
According to clinical trials developed by Novartis (called ORION-3), inclisirane achieved, within 17 months of administration, "sustained reductions in c-LDL cholesterol, PCSK9 and other lipoproteins" with "good tolerability" by patients "and a good safety profile".
According to the European Medicines Agency (EMA), which approved inclisirane in 2020, the most common side effects of Leqvio (which can affect up to 1 in 10 people) are reactions such as pain, redness and rash at the injection site.
Atherosclerosis is a common condition that occurs when a substance called plaque builds up inside the arteries. Atherosclerotic cardiovascular disease is a "chronic, generalised and progressive pathology that affects the arteries, thickening and hardening their inner 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 atherosclerotic plaque can cause a heart attack, angina pectoris or stroke.
In Spain, cardiovascular diseases are the leading cause of death, accounting for one in four deaths. In 2021, 119,196 people died as a result of these pathologies, 26.4% of all deaths in the country. Cardiovascular diseases are also the leading cause of hospitalisation (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%) have high cholesterol levels, although most of them do not know it.
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