In Puglia in 2020 there were over 14,000 deaths caused by cardiovascular diseases, including ischemic and cerebrovascular diseases, which represent 33% of the total deaths 1 . Approximately 700,000 Apulian citizens suffer from dyslipidemia 2 of which approximately 40% are treated with lipid-lowering therapies and 49% of these are patients at high or very high cardiovascular risk 3 . LDL cholesterol (LDL-C) is the main modifiable risk factor for the reduction of cardiovascular risk, as demonstrated by decades of experience in clinical studies which highlight its direct correlation with atherosclerotic cardiovascular disease (ASCVD) 4,5.
In fact, the accumulation of LDL cholesterol over time can determine the formation of atherosclerotic plaque on the arteries, thus increasing the risk of acute events such as myocardial infarction and stroke 6 . Following an acute event, cardiovascular prevention becomes a priority, both to improve the quality of life and to reduce the risk of subsequent events. Proper management of patients with hypercholesterolemia must, therefore, necessarily aim at achieving the LDL cholesterol therapeutic targets recommended by the joint guidelines of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS).
This goal is also very complex in Puglia, where over 60% of patients with hypercholesterolemia do not adequately control LDL cholesterol values despite lipid-lowering therapies 7.
Today the therapeutic armamentarium for the treatment of hypercholesterolemia has been further enriched with inclisiran. The Novartis drug received reimbursement from AIFA last October and is now also available in Puglia. Inclisiran is indicated for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia (conditions characterized by high levels of fats, including cholesterol, in the blood).
Inclisiran can be prescribed in combination with a statin or a statin combined with other oral lipid-lowering therapies. In summary, patients who do not respond to traditional therapy with drugs based on statins and ezetimibe, or are intolerant to them, can benefit from inclisiran, as well as patients suffering from severe forms of familial dyslipidemia. Inclisiran is the first small interfering RNA (siRNA) therapy for lowering LDL cholesterol, and represents a new approach to the management of patients with hypercholesterolemia.
Due to its mechanism of action, it directly inhibits the production of the PCSK9 protein, thereby increasing the liver’s ability to absorb LDL cholesterol 8 . This mechanism consequently leads to a reduction in the levels of LDL cholesterol present in the blood 9 . Inclisiran is given to patients by a healthcare professional. After the first injection, the next dose follows 3 months later and then every 6 months, twice a year.
“The availability of this drug in the Puglia Region represents a promising opportunity to improve not only the treatment of atherosclerotic disease – declares Natale Daniele Brunetti, Director of the Complex Structure of University Cardiology of the Policlinico Riuniti of Foggia – but also the quality of life of all patients with hypercholesterolemia. We are very confident of the results demonstrated by the mechanism of action of this drug which, added to our experience, will help an increasing number of patients to reach the desired LDL cholesterol target levels in a stable and controlled manner”. Helping these patients to reach the target levels of LDL cholesterol and maintaining them over time is a precise objective for the Puglia region, such as that of the best territorial management of the disease.
“The higher the LDL cholesterol, the greater the risk of cardiovascular events and the worse the life expectancy, especially for people at higher risk, such as those who have already had events or who have other risk factors associated (diabetes, hypertension, obesity). Unfortunately, there is little awareness – concludes Pasquale Caldarola, Director of Cardiology of the San Paolo Hospital and of the Cardiological Department of the ASL of Bari – and poor adherence to recommended treatments. In fact, only 40% of patients in our region are able to control LDL cholesterol levels with current therapies. We strongly believe in this effective and safe cutting-edge drug that offers us an important therapeutic advantage to guarantee a better outcome for eligible patients”.