Alirocumab, brand name Praluent, received FDA approval July 24. The injectable drug, from Regeneron and Sanofi, is the first in a new class of drugs called PCSK9 inhibitors. It works by making the liver more efficient at getting rid of LDL, or bad cholesterol. Statins inhibit the enzyme HMG-CoA reductase which plays a central role in the production of cholesterol and were first marketed in the late 1980s.
“Studies are showing reductions of LDLs by up to 75 percent, which is very impressive. This really is a big thing,” said Charles Dahl, MD, a cardiologist at Utah Valley Regional Medical Center. Dr. Dahl is also the county’s only certified lipidologist, a physician who specializes in the prevention of lipid disorders or related metabolic diseases which often lead to heart disease.
Praluent is injected at home every two weeks using an epi pen. Dr. Dahl said the drug is ideal for patients who have known heart disease or those with inherited high levels of LDL cholesterol. Patients who can’t tolerate statin medications may also benefit from the new medication.
As with most medications, the drug has potential side effects, including itching, swelling, and pain or bruising from the injection. Patients can also experience cold- and flu-like symptoms. It’s also a very expensive medication, but assistance programs are available to help cover the cost.
“This is not meant to replace statins. No one is to stop taking statins and start this. Everyone needs to consult their own physician about this medication,” said Dr. Dahl.
Dr. Dahl said physicians are now eager to see if the new drug will actually reduce coronary events, such as heart attacks. He’s participating in outcome studies for two companies who manufacture alirocumab. Preliminary studies are encouraging, but more time is needed for definitive results.