Only two doses per year are sufficient to effectively and sustainably reduce LDL cholesterol. This result is possible thanks to the mechanism of action of the first therapy based on a small interfering RNA (siRNA) which acts by increasing the ability of the liver to absorb LDL cholesterol, the ‘bad’ one, which can seriously jeopardize cardiovascular health.
In Italy, every year, more than 224,000 people die from cardiovascular diseases: of these, just under 50,000 are attributable to failure to control cholesterol. The new drug has just received reimbursement by the Italian Medicines Agency with the indication for adults with primary hypercholesterolemia (familial and non-familial heterozygous) or mixed dyslipidemia.
If your cholesterol is high, be careful not to abandon treatment
by Federico Mereta
Cholesterol and cardiovascular risk
LDL cholesterol is considered the main modifiable risk factor for reducing cardiovascular risk. There are now many scientific studies that highlight the direct correlation between LDL cholesterol and atherosclerotic cardiovascular disease caused by an excess of ‘bad’ cholesterol in the blood which, adhering to the internal walls of the arteries, leads to the accumulation of fatty deposits (atheroma or atherosclerotic plaque) and makes it more difficult for blood to pass through. Patients often do not have specific symptoms and, therefore, are unaware of the risk of developing this dangerous condition.
For 8 out of 10 patients the LDL is too high
Despite being the most easily modifiable cardiovascular risk factor, unfortunately obtaining an effective and sustained reduction in Ldl cholesterol levels over time is still a challenge, so much so that 8 out of 10 high-risk patients are unable to reduce their value to levels recommended.
“We know that cardiovascular disease remains the leading cause of death worldwide and causes more deaths than all cancers combined,” he says. Emanuela Folco, Italian Foundation for the Heart. “Fortunately, we also know that it is possible to prevent 80% of cardiovascular events with an adequate preventive action, promoting awareness of the real modifiable risk factors to be kept under control, and optimizing patient management with paths that facilitate patient adherence “.
High cholesterol, even without other risk factors, is a danger to the heart
by Federico Mereta
A new therapeutic approach
Blood cholesterol levels can be lowered in the first place with diet and physical activity. But when these lifestyle corrections aren’t enough, drug therapy becomes inevitable.
Several opportunities are available: from classic statins, to combinations of statins with a selective inhibitor of intestinal cholesterol absorption, to monoclonal antibodies (to be used only in severe and selected cases) and today to this new biological therapy, inclisiran, to base of small-interfering RNA (siRNA) for the reduction of LDL cholesterol which represents a new approach to the management of patients with hypercholesterolemia.
Cholesterol, so monoclonal antibodies protect the heart in people at very high risk
“This molecule is the progenitor of a new class of highly innovative drugs that directly target the root of atherosclerotic disease rather than its symptoms, thanks to a mechanism of action that allows to reduce LDL cholesterol levels not only effectively, but also sustained over time. An important step forward to reach the therapeutic goal recommended by the new European guidelines in an increasingly large number of patients “, declares Pasquale Perrone Filardielected president of the Italian Society of Cardiology (Sic).
The role of messenger RNA
But how exactly does the new drug work? “Its mechanism of action is very innovative as it falls into the class of RNAi (RNA interference) therapeutic agents, drugs that silence messenger RNAs (mRNAs),” he explains. Furio Colivicchi, president of the National Association of Hospital Cardiologists (Anmco). “It is a small double-stranded interfering RNA (siRNA) with a high affinity for the liver, in which it reduces the levels of a protein called PCSK9, which is involved in cholesterol metabolism. This mechanism increases the capacity of the liver. to absorb LDL cholesterol and consequently leads to a reduction in the levels of LDL cholesterol present in the blood “.
For whom it is indicated
In Italy, the new drug is indicated, in addition to the diet, in combination with a statin or a statin with other oral lipid-lowering therapies in patients unable to achieve the goals for LDL with the maximum tolerated dose of a statin, or in monotherapy or in combination with other lipid-lowering therapies in patients intolerant to statins or for whom a statin is contraindicated.
But there is another feature that makes the new drug interesting for both doctors and patients: its mode of administration which involves only two injections per year, subcutaneously.
How it is administered
After the first injection, the next dose is given 3 months apart and every 6 months thereafter. The drug is prescribed by the specialist and its administration is carried out by a healthcare professional.
If your cholesterol is high, be careful not to abandon treatment
by Federico Mereta
“This is an important therapeutic innovation also because the patient cannot give himself the injection that goes to a health worker during the check-up visit: this guarantees us that the patient adheres to the therapy”, declares Colivicchi who adds . “This new drug is very practical to use even with respect to monoclonal antibodies which must be collected every 2-3 months at the hospital pharmacy and which must be kept guaranteeing the cold chain because they are thermolabile drugs. With this new drug there are no problems of this type and this facilitates the patient’s life “.