In a nutshell
This study investigated whether alirocumab (Praluent) is effective and safe in treating patients with cardiovascular disease.
Some background
Cardiovascular disease includes a range of diseases that causes blood flow to the heart, brain or body to be reduced. Bad cholesterol (low-density lipoprotein (LDL) cholesterol) and fatty deposits build up inside arteries causing them to harden and narrow (atherosclerosis).
Atherosclerosis can cause blood clots to develop, which can also block blood flow. Atherosclerosis and blood clots can cause a cardiovascular event to occur such as a heart attack or stroke (reduced blood flow to the brain).
Treatment for cardiovascular disease is aimed at reducing LDL cholesterol. Drugs include traditionally used statin drugs that inhibit the production of LDL cholesterol and also newer drugs such as alirocumab (Praluent). Alirocumab is a protein designed to break down LDL cholesterol.
Methods & findings
This study looked at alirocumab and investigated whether it was effective and safe at reducing LDL cholesterol in patients with cardiovascular disease.
The study included 2,341 patients with cardiovascular disease and who had a high risk of having a cardiovascular event (such as a heart attack or stroke). Patients were already receiving statins at the maximum tolerated dose i.e. the highest dose that doesn’t cause too many side effects. Patients randomly received either injection of alirocumab (150 mg) or a placebo every 2 weeks for 78 weeks.
The study found that after 24 weeks of receiving treatment, LDL cholesterol levels were 62% lower in the alirocumab group than in the placebo group. This lowered effect remained consistent for the rest of the 78 weeks.
However, the alirocumab group had a higher rate of injection-site reactions, muscle pain, neurocognitive events (such as amnesia, memory impairment, and confusion) and eye related side effects.
The risk of death caused by cardiovascular events was 48% lower in the alirocumab group, than with placebo.
The bottom line
The study concluded that alirocumab, when added to statin therapy, significantly reduced LDL cholesterol levels and cardiovascular events.
The fine print
The duration of the study (78 weeks) was relatively short for a disease that some patients may have for several years.
What’s next?
If you or someone you know are receiving the highest tolerated dose of statins for cardiovascular disease, talk to a doctor about receiving alirocumab to help further reduce the risk of cardiovascular events.
Published By :
The New England Journal of Medicine
Date :
Mar 16, 2015