High cholesterol, the experimentation of the drug Inclisiran begins at Monzino, already baptized the anti-heart attack vaccine
The Monzino Cardiology Center he ‘enrolled’ the first three patients who, in the context of the international multicenter study Victorion-2Pthey will receive includingthe drug that Eugene Brauwnwal, father of modern cardiology, he did not hesitate to define the future “anti-heart attack vaccine”. The study will involve over 10 thousand patients worldwide, with the aim of demonstrating that the new drug of Novartis – which, like a vaccine, is only given twice a year – can reduce the risk of serious cardiovascular events, such as heart attack e strokehalving the levels of cholesterol ‘bad ‘LDL-C.
High cholesterol: Inclisiran is a more effective drug than statins
“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 even more important in the 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. range of anti-cholesterol drugsincluding notes statinsthe desirable LDL-C targets to reduce the risk of recurrence are often difficult to achieve. 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% both in patients with cerebrovascular disease (Cevd) than in patients with polyvascular disease (PVD). In these subjects, even the statin therapy, even at the maximum tolerated dose, had not fully achieved the goal “, explains Professor Piergiuseppe Agostonidirector of the Department of Critical and Rehabilitation Cardiology Monzinofull professor of cardiovascular disease atUniversity of Milan and Principal Investigator al Monzino of study Victorion-2.
High cholesterol and mRNA heart attack vaccine
“Inclirisan has been defined as one of the most important innovations in cardiovascular prevention in the new millennium and is the forefather 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 it’s even more interesting because silencing a sequence of Messenger RNA (mRNA) at the level ofthe liver (liver cell), through a series of cascade mechanisms, produces a very important reduction in cholesterol values. Hence the parallelism with anti vaccines Sars-CoV-2 which, albeit with a very different mechanism, they exploit mRNAa sort of dictionary capable of translating into practice what is written in our genetic material “, he adds Massimo Mapelli, staff member of the firm al Monzinowith Elisabetta Salvioni, Fabiana De Martino e Irene Mattavelli.
“Inclirisan it is a precision drug: it is injected under the skin, as happens for example with heparin, and goes directly to a specific target without other targets in different points of the body. As a result, it is well tolerated and causes less severe side effects than high-dose statins. 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 he had a serious heart attack two months ago and continues, despite a scrupulous intake of the therapy, to have cholesterol values too high compared to the threshold value. We are particularly happy that we started with a female subject because. as is well known, in clinical studies, patients are often under-represented, despite having a cardiovascular risk comparable to that of men “, underline the three researchers.
High cholesterol and heart attack vaccine: two administrations per year are enough
“Another key point is the patient’s compliance with taking the therapies. Many studies show that in post-infarto 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 “, explains Mapelli.
I study Victorion-2P it is randomized in a double-blind manner (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 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 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 from outside the EU, 275 EU and 20 Italians, with a recruitment target in our country of 200 subjects.
“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 life of the patient, but the values of LDL cholesterol ‘spread’ over many years. This is also why we at Monzino strongly believe in this cutting-edge drug, which modifies the molecular mechanisms underlying the hyperproduction of low-density cholesterol. We wouldn’t be surprised that, as is often the case with these advanced studies, too 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.