The Victorion-2P international multicenter study kicks off at the Monzino Cardiology Center: three patients will be administered Inclisiran, the drug that Eugene Brauwnwal, father of modern cardiology, has defined as the future “anti-heart attack vaccine“. The study will involve over 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, halving LDL-C “bad” cholesterol levels.
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The key role of LDL-C cholesterol
“LDL-C is known to play a key role in the development and progression of cardiovascular and atherosclerotic diseases and it is shown that lowering levels in the blood results in a reduction in their incidence and mortality. An effect that is still present. more important in subjects 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 which this study is focused. To date, in fact, despite having a wide range of anti-cholesterol drugs, including the well-known statins, the desired LDL-C targets to reduce the risk of relapse are often difficult to obtain. Inclirisan is the first drug of a new class that, in previous clinical studies, has already been shown to be able to lower LDL-C levels by 50% both in patients with cerebrovascular disease (Cevd) and in patients with polyvascular disease (PVD). at the tolerated dose, he had not fully achieved the goal “, explains the professor Piergiuseppe Agostonidirector of the Monzino Department of Critical and Rehabilitative Cardiology, 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 cardiovascular prevention in the new millennium and is the progenitor of a new class of anti-cholesterol drugs, which act with a” gene silencing “mechanism. 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 by 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 anti Sars-CoV-2 vaccines which, albeit with a very different mechanism, exploit mRNA, a sort of dictionary capable of translating into practice what is written in our genetic material “he adds Massimo Mapellia staff member of the studio al Monzino, together with Elisabetta Salvioni, Fabiana Martino e Irene Mattavelli.
“Inclirisan is a precision drug: it is injected under the skin, as is the case for heparin, and goes directly to a specific target without other targets in different parts of the body. This is why it is well tolerated and causes less serious side effects than to statins in high doses. Low toxicity is a fundamental aspect because the candidates for the study are those in “secondary prevention”, that is people who in the past have already had a cardio-cerebro-vascular event. For example, the patient recruited for before here at Monzino he had a serious 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 female subject because, as it is known, in clinical trials patients are often under-represented, despite having a cardiovascular risk comparable to that of men ” underline the three researchers.
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“Another key point is the patient’s compliance with taking the therapies. Many studies show that in the post-heart attack up to 40% of drug prescriptions are disregarded for various reasons over 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 “, explains Mapelli.
How the study works
The Victorion-2P study is a randomized double-blind study (Inclisiran vs Placebo) and is administered 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 status. health and record any events (heart attacks, angioplasty, heart surgery …) to verify the differences in the two arms. At the moment in Italy, in addition to Monzino, other 5 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 from outside the EU, 275 EU and 20 Italians, 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 the cholesterol, the greater the reduction in the risk of events. It is important to note, as recently demonstrated, that the punctual value at a moment x of the patient’s life is not fundamental, but LDL cholesterol values ”spread” over many years. Also for this reason we at Monzino strongly believe in this cutting-edge drug, which modifies the molecular mechanisms underlying the hyperproduction of low density cholesterol. We would not be surprised that, as it often happens for these advanced studies, even Victorion-2P is stopped early, before having enrolled all the patients, because the drug treatment arm is statistically more favorable than the placebo arm “, concludes Agostoni.