The new alirocumab is available in Italy in monthly administration (300 mg), an anti-PCSK9 monoclonal antibody which rapidly and intensively reduces LDL cholesterol levels by up to 66% in patients at very high cardiovascular risk. The new dosage of alirocumab, in addition to allowing a single monthly administration, comes in a latest generation auto-injector which allows the patient to easily self-administer the therapy at home.
Alirocumab monthly represents a further step forward for the management of hypercholesterolemia: LDL cholesterol is in fact recognized as a causal factor in the over 18.6 million victims of cardiovascular diseases in the world and which in our country account for 34.8% of deaths.
In patients at very high cardiovascular risk, secondary prevention aims to arrest the progression of atherosclerosis in order to prevent the first acute cardio-cerebral vascular event (heart attack or stroke) or further events in the case of patients with acute coronary syndrome. The intensive and rapid reduction of LDL cholesterol, obtained thanks to anti-PCSK9 monoclonal antibodies, allows the therapeutic targets of LDL levels recommended by international guidelines to be reached, establishing itself as an effective therapeutic strategy for the reduction of cardiovascular mortality.
The 2019 ESC/EAS Guidelines identify patients with acute coronary syndrome as very high cardiovascular risk patients as well as patients with hypercholesterolemia and other conditions such as coronary artery disease, peripheral arterial disease, diabetes mellitus, in which the progression of the atherosclerotic disease can lead to plaque rupture, resulting in a first potentially fatal acute event.
In this scenario, alirocumab, through a significant and rapid reduction in LDL cholesterol, has been shown to reduce cardiovascular events and all-cause mortality. With the new monthly alirocumab, the latest generation auto-injector is added to the convenience of once-a-month administration, designed to facilitate easier home administration for the patient.
«The new monthly alirocumab – explains Marino Scherillo, director of Interventional Cardiology Utic, director of the Cardio Thoraco Vascular Department, Aorn «San Pio» of Benevento – combines the consolidated effectiveness of the drug with a device that represents a real innovation for patients. The auto-injector allows the patient to administer it at home in complete autonomy in just two steps. A triple feedback system – visual, auditory and tactile – allows the patient to verify that the therapy has been administered correctly. Thanks to an innovative device, it is possible to start therapy against high cholesterol in patients with acute myocardial infarction in an early, effective and simple way: strike early, strike strong and strike easy.”
«In Sanofi – explains Andrea Rizzi, Country Medical Head, Sanofi General Medicines – we are driven by a great innovative force that has the ambition to challenge the boundaries of science to bring concrete answers, in terms of care and treatment, to the needs of patients and caregivers. In the cardio-metabolic area, in the field of dyslipidemia, our commitment is alongside patients, caregivers and the medical profession to translate the result of clinical research into concrete value also in the field of prevention of cardiovascular events, with particular attention to patients at very high risk. We believe that the clinical value of monthly alirocumab, combined with the innovation brought by the new auto-injector, can significantly contribute to drastically reducing and preventing the impact, in terms of mortality, that cardiovascular diseases still have today in Italy and around the world” .
Alirocumab is a cholesterol-lowering monoclonal antibody indicated in adults with primary hypercholesterolemia (heterozygous familial or non-familial) or mixed dyslipidemia, and in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolaemia (HeFH – heterozygous familial hypercholesterolaemia) as an adjunct to diet ; it is also indicated in cases of proven atherosclerotic cardiovascular disease to reduce cardiovascular risk by reducing LDL cholesterol levels in addition to correcting other risk factors. Alirocumab is indicated in combination with a statin or a statin with other lipid-lowering therapies in patients unable to achieve LDL cholesterol goals on the maximum tolerated dose of statins, or as monotherapy or in combination with other lipid-lowering therapies in patients who are intolerant to statins or for whom the statin is contraindicated.
