The mission is: to lower ‘bad’ cholesterol (Ldl-C) as much as possible to protect patients at high cardiovascular risk. The decision to lower the LDL cholesterol threshold from 100 to 70 mg / dL for the use in secondary prevention of Pcsk9 inhibitors goes in this direction, in synergy with the reference scientific societies and the Italian drug agency Aifa, treatment that is aimed at ‘cutting’ bad cholesterol levels, in a heart-saving key. The “turning point” is in a determination published in the Official Journal: it will allow Italian doctors to use alirocumab, a monoclonal antibody that significantly reduces bad cholesterol (about 60%, according to data released in a note), even for those patients which until now did not fall within the prescribing parameters charged to the National Health Service, despite being classified as ‘high cardiovascular risk’. Alirocumab works with an innovative mechanism by binding to the Pcsk9 protein, increasing the number of LDL receptors and thus reducing bad cholesterol. “This decision marks an important turning point for the secondary prevention of cardiovascular diseases in our country, allowing early intervention in patients at high cardiovascular risk – highlights Ciro Indolfi, president of the Italian Society of Cardiology (Sic) – Today it has been shown that LDL cholesterol is the cause of atherosclerosis and therefore its reduction represents one of the main objectives for limiting cardiovascular events such as myocardial infarction and mortality “. This is, continues Indolfi, “the reason why the Sic guidelines recommend in high-risk patients a decrease in LDL cholesterol below 55 mg / dL and even, in some categories, below 40 mg / dL. These ambitious goals today can also be achieved thanks to Pcsk9 inhibitors that have demonstrated a clear clinical benefit in high-risk patients “. Patients suffering from cardiovascular disease, adds Furio Colivicchi, president of the National Association of Hospital Cardiologists (Anmco), “have a very high risk of experiencing an acute, disabling or life-threatening cardio-cerebrovascular event. Pharmacological preventive measures must be incisive, in order to guarantee effective containment of the risk and safeguard the future of patients “. The Aifa provision that accepts the indications of Anmco and Sic, continues Colivicchi, “will simplify the access of patients with cardiovascular disease to an innovative and proven therapy. Patients with a very high cardiovascular risk profile will now be able to reach more facilitates the therapeutic goals recommended by the Guidelines, effectively reducing LDL cholesterol “. In Italy, cardiovascular diseases still represent the main cause of death and are responsible for 44% of all deaths. Ischemic heart disease, in particular, is the leading cause of death in the country (28% of deaths), while cerebrovascular accidents are in third place with 13%, after tumors. Furthermore, the prevalence of some risk factors, in particular diabetes and obesity, is increasing and, despite the fact that a greater number of patients survive the first cardiovascular event, the possibility of relapse remains strong. These numbers could be reduced, as the recent guidelines of the European Society of Cardiology recall, if prevention strategies are increasingly implemented, especially for those patients identified at high cardiovascular risk. Among these strategies is the lowering of LDL cholesterol. In the presence of previous cardiac events such as heart attack, cerebrovascular events, revascularization interventions, secondary prevention plays a fundamental role in helping to lower the risk of new cardiovascular events. The association of therapy with a series of good daily practices and an active lifestyle, experts indicate, are successful in counteracting the worsening of this condition. Alirocumab, comments Andrea Rizzi, Medical Head General Medicines of Sanofi Italy, “can count on the evidence of 28 global studies on more than 32,100 patients in over 3,000 centers that have led to the publication of more than 25 papers in primary-level journals. we welcome the decision taken by the regulatory body and strongly supported by scientific societies, aimed at re-evaluating the use thresholds of our Pcsk9 inhibitor “.
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