Control of lipid levels is one of the most effective strategies for 
cardiovascular (CV) event prevention. In fact, many clinical trials have clearly 
demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, 
primarily with statins, reduces major CV events and mortality. The evidence from 
these trials has been useful in designing the cholesterol treatment guidelines, 
which are mainly aimed at preventing and managing cardiovascular disease (CVD). 
However, available data indicate that a large proportion of patients fail to 
achieve lipid goals, and this is particularly frequent in patients at high or 
very high CV risk. Furthermore, owing to side effects, a significant percentage 
of patients cannot tolerate statin treatment. Hence, researchers have focused 
their attention on novel LDL-C-lowering agents that act via mechanisms distinct 
from that of statins. Among the new compounds under investigation, the 
monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9) 
seem particularly promising, having recently been shown to be well tolerated and 
highly effective at lowering LDL-C, with a possible effect on the occurrence of 
CV events. Currently, alirocumab is approved by the US Food and Drug 
Administration (FDA) as an adjunct to diet and maximally tolerated statin 
therapy for use in adults with heterozygous familial hypercholesterolemia (FH) 
or those with atherosclerotic CV disease who require additional LDL-C lowering; 
it has also been recently approved by the European Medicines Agency (EMA) for 
use in patients with heterozygous FH, non-familial hypercholesterolemia or mixed 
dyslipidemia in whom statins are ineffective or not tolerated. Evolocumab is 
approved by the FDA as an adjunct to diet and maximally tolerated statins for 
adults with hetero- and homozygous FH and those with atherosclerotic CV disease 
who require additional lowering of LDL-C, and by the EMA in adults with primary 
hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, in 
combination with a statin or a statin with other lipid lowering therapies in 
patients unable to reach LDL-C goals with the maximum tolerated dose of a 
statin; alone or in combination with other lipid lowering therapies in patients 
who are statin-intolerant, or those for whom a statin is contraindicated. 
Evolocumab is also indicated in adults and adolescents aged 12 years and over 
with homozygous familial hypercholesterolemia in combination with other 
lipid-lowering therapies.