A new class of cholesterol-busting drugs is providing hope to people with inherited high cholesterol, as well as those with cardiovascular disease who can’t manage their cholesterol with other medications.
The two medications – Praluent, produced by Sanofi-Aventis, and Rapatha, made by Amgen – are the first to be approved in a new category of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. The U.S. Food and Drug Administration (FDA) approved the drugs in 2015.
What is cholesterol?
The body has two types of cholesterol – low-density lipoprotein (LDL) cholesterol (often called “bad” cholesterol) and high-density lipoprotein (known as “good” cholesterol). Cholesterol is a fat-like substance found in all cells that is used to make hormones, vitamin D and more. But cholesterol is also found in some of the food we eat. The body needs a healthy level of both types of cholesterol.
High LDL levels can lead to a buildup of cholesterol in the walls of the arteries that carry blood from the heart to other parts of the body. The buildup puts people at an increased risk of developing cardiovascular disease, which is the leading cause of death for both men and women in the United States, according to the U. S. Centers for Disease Control and Prevention. Heart disease accounts for one in every four deaths in the nation.
Reducing bad cholesterol
Many people with high cholesterol can manage the condition with medications known as statins. But in some cases, statins aren’t enough to control cholesterol levels.
Both Praluent and Rapatha have the potential to lower LDL cholesterol levels by blocking the ability of PCSK9 to work. PCSK9 is a protein that reduces the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9, the liver has more receptors available to get rid of LDL cholesterol from the blood stream. The prescription drugs are now readily available from reputable organizations such as Pharmacy Advantage.
Both injectable drugs are recommended for patients with hypercholesterolemia, an inherited form of high cholesterol caused by a mutation in the PCSK9 gene. The new class of drugs is also recommended for patients who have cardiovascular disease (such as being at risk for heart attack and stroke) who haven’t been able to manage their high cholesterol levels with statins. The FDA approved the use of Praluent and Repatha for patients who also undergo dietary changes and maximally tolerated statin therapy.
Proven results
In clinical trials, patients taking Praluent had an average reduction of LDL cholesterol ranging from 36 to 59 percent, compared to placebo, according to FDA. Patients taking Repatha in clinical trials had an average reduction in LDL cholesterol of about 60 percent, compared to those who took a placebo, reported the FDA.
Health experts say Praluent and Rapatha could offer life-altering benefits to individuals with extremely high cholesterol levels. Without these drugs, some people must undergo a procedure called apheresis, during which they sit for hours while their blood flows into a machine that eliminates the LDL cholesterol. But the LDL builds up again, and most patients require another session of apheresis within weeks.