The first three patients in Italy were enrolled. But the research will involve over 10 thousand in the world. The goal is to test Inclisiran, the “heart attack vaccine“, according to the definition of Eugene Brauwnwal, father of modern cardiology. With two administrations per year, the drug is expected to reduce the risk of cardiovascular events. From the Monzino of Milan will start there experimentation with the three patients who, within the international multicenter study “Victorion-2P”, will receive the vaccine. The “miraculousness” of the vaccine is due to its ability to reduce the levels of bad cholesterol, LDL-C.
“It is known that LDL-C plays a key role in the development and progression of cardiovascular and atherosclerotic diseases and it is shown that, by lowering its levels in the blood, a reduction in their incidence and mortality is achieved”, he explains. Piergiuseppe Agostoni, Director of the Monzino Department of Critical Cardiology and Rehabilitation, Professor of Cardiovascular Diseases at the University of Milan and Principal Investigator at Monzino of the Victorion-2 study. The effect of the drug would be even more important in moles subjects most at risk, like those who have already experienced a cardiovascular event (heart attack and stroke) in their history. These are precisely the patients on which this study is focused. «To date, in fact, despite having a wide range of anti-cholesterol drugs available, including the well-known statins, the desirable Ldl-C targets to reduce the risk of relapse are often difficult to obtain.
THE CLASS – Inclirisan is the first drug of a new class that, in previous clinical studies, has already shown that it can lower Ldl-C levels by 50% in both patients with cerebrovascular disease and in patients with polyvascular disease. In these people, even the statin therapy, even at the maximum tolerated dose, had not fully achieved the goal “, explained Agostoni. Inclisiran is a precision drug: it is injected under the skin and goes directly to a specific target with no other targets in different places in the body. This is why it is well tolerated and causes less serious side effects than other drugs used to lower cholesterol.
«The low toxicity is a fundamental aspect because the candidates for the study are those in” secondary prevention “, ie people who in the past have already had a cardio-cerebro-vascular event. For example, the patient first recruited here at Monzino had a severe heart attack two months ago and continues, despite a scrupulous intake of the therapy, to have cholesterol values that are too high compared to the threshold value. We are particularly happy to have started with a woman because, as is known, in clinical trials patients are often under-represented, despite having a cardiovascular risk comparable to that of men “, explain the researchers Massimo Mapelli, a member of the study’s staff at Monzino, together with Elisabetta Salvioni, Fabiana De Martino and Irene Mattavelli. «Many studies – explains Mapelli – show how in the post-heart attack up to 40% of pharmacological prescriptions are disregarded for various reasons during the 12 months following the event, canceling the benefit. A drug that is administered only twice a year, perhaps during a scheduled outpatient visit, also allows us to overcome this problem ».
RECRUITS – The Victorion-2P study provides for administration twice a year with a follow-up variable between 3-6 years, in which the patient is periodically reviewed in the clinic to check his health and record any events (heart attacks, angioplasty, heart surgery) to check for differences in the two arms. At the moment in Italy, in addition to Monzino, 5 other centers are active or in the process of being activated, but the number is constantly evolving. The total centers that would like to open recruitment worldwide are 806, of which 275 in Europe and 20 Italians, with an estimated recruitment target in our country of 200 people.