Heart attack vaccine, the trial in Italy starts
A blood sample will reveal who is at risk of heart attack (even with normal values)
The new drug will be administered to the first three patients at the Monzino Cardiology Center and will have to demonstrate that it is able to reduce the risk of serious cardiovascular events, such as heart attack and stroke, by halving the levels of "bad" LDL-C cholesterol
HEART COUNTER
A blood sample will reveal who is at risk of heart attack (even with normal values)
by Federico Mereta @laRepubblica
MARCH 11, 2022
The international multicenter study Victorion-2P kicks off at the Monzino Cardiology Center: three patients will be given Inclisiran, the drug that Eugene Brauwnwal, father of modern cardiology, has called the future "anti-infarction vaccine".
The study will involve more than 10,000 patients worldwide, with the aim of demonstrating that Novartis' new drug - which, like a vaccine, is administered only twice a year - is able to reduce the risk of serious cardiovascular events, such as heart attack and stroke, by halving the levels of "bad" LDL-C cholesterol.
The key role of LDL-C cholesterol
"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 their levels in the blood, a reduction in their incidence and mortality is achieved.
An effect that is even more important in those most at risk, such as those who have already experienced a cardiovascular event (heart attack and stroke) in their history.
These are the patients on whom this study focuses. To date, 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 recurrence are often difficult to achieve.
Inclirisan is the first drug in a new class that, in previous clinical trials, has already been shown to lower LDL-C levels by 50% in both patients with cerebrovascular disease (Cevd) and patients with polyvascular disease (Pvd).
In these subjects, even statin therapy, even at the maximum tolerated dose, had not fully achieved the goal", explains Professor Piergiuseppe Agostoni, director of the Department of Critical and Rehabilitation Cardiology Monzino, full professor of cardiovascular diseases at the University of Milan and Principal Investigator at Monzino of the Victorion-2 study.
“Inclirisan has been defined as one of the most important innovations in the field of cardiovascular prevention in the new millennium and is the progenitor of a new class of anti-cholesterol drugs, which act with a mechanism of "gene silencing".
These are molecules that interfere in a targeted way on specific targets by deactivating them, and therefore, so to speak, silencing them.
Inclirisan is even more interesting because silencing a sequence of messenger RNA (mRNA) at the level of the hepatocyte (liver cell), through a series of cascade mechanisms, produces a very important reduction in cholesterol values.
Hence the parallelism with the sars-coV-2 vaccines that, although with a very different mechanism, exploit mRNA, a sort of dictionary able to translate into practice what is written in our genetic material" adds Massimo Mapelli, member of the staff of the study at Monzino, together with Elisabetta Salvioni, Fabiana De Martino and Irene Mattavelli.
"Inclirisan is a precision drug: it is injected subcutaneously, as is the case for example for heparin, and goes directly to a specific target without other targets in different points of the body. This is why it is well-tolerated and causes less serious side effects than high-dose statins. Low toxicity is a fundamental aspect because the patients eligible for the study are those in "secondary prevention", i.e. people who have already had a cardio-cerebro-vascular event in the past. For example, the patient recruited first here at Monzino had a serious heart attack two months ago and continues, despite a scrupulous intake of therapy, to have cholesterol values too high compared to the threshold value. We are particularly pleased to have started with a female subject because, as is known, in clinical trials patients are often under-represented, despite having a cardiovascular risk comparable to that of men", underline the three researchers.
“Another key point is the patient's compliance with the taking of therapies. Many studies show that in the post-infarction up to 40% of drug prescriptions are disregarded for various reasons within 12 months after the event, canceling the benefit. A drug that is administered only 2 times a year, perhaps during an already scheduled outpatient visit, allows to overcome this problem too", explains Mapelli.
How the study works
The Victorion-2P study is randomized in double-blind (Inclisiran vs Placebo) and involves administration twice a year with a follow-up varying between 3-6 years, in which the patient is periodically reviewed in the clinic to check his health status and record any events (heart attacks, angioplasties, heart surgeries ...) to verify the differences in the two arms.
At the moment in Italy, in addition to the 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 531 non-EU, 275 EU and 20 Italian, with a recruitment target in our country of 200 subjects.
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"In recent decades the concept has been established that the lower cholesterol, the greater the reduction in the risk of events. It is important to note, as recently demonstrated, that it is not the point value at a time x of the patient's life that is fundamental, but the LDL cholesterol values "spread" over many years. Also for this reason we at Monzino believe very much in this cutting-edge drug, which modifies the molecular mechanisms underlying the overproduction of low-density cholesterol. We would not be surprised that, as is often the case with these advanced studies, Victorion-2P is also discontinued early, before all patients have been enrolled, because the drug treatment arm is statistically more favorable than the placebo arm", concludes Agostoni.
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