PCSK9 inhibitors show promise for problematic cholesterol

The Food and Drug Administration last week approved a new cholesterol medication called Praluent, the first injection in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

PCSK9 is a protein that prevents the liver from metabolizing a higher rate of LDL cholesterol, which when left in the bloodstream poses a significant risk to the heart. Praluent works by inhibiting the PCSK9 protein, allowing more LDL to be metabolized by the liver. Compared to placebo, Praluent users saw LDL reduction of up to 59 percent.

The FDA’s approval of Praluent can help patients with particularly hard to treat cholesterol issues, especially those already on statin-based LDL treatments. PCSK9 inhibitors can be taken concurrently with statin treatments.

“Multiple clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke. A trial evaluating the effect of adding Praluent to statins on reducing cardiovascular risk is ongoing,” FDA spokesperson Eric Pahon said.

Preliminary results for the combined therapy published in the New England Journal of Medicine show promise, effectively cutting the rate of cardiovascular events in half according to lead researcher Marc Sabatine of Brigham and Women's Hospital.

Injections occur every two weeks and range from 75 to 150 milligrams.

Itching, swelling, and pain or bruising of the infection site were the most common reactions according to the FDA’s findings, with more dangerous side effects including serious allergic reactions that may require hospitalization.

“Patients should stop using Praluent and get medical help if they experience symptoms of a serious allergic reaction,” Pahon said.

Want to get notified whenever we write about FDA Office of Medical Products and Tobacco ?
Next time we write about FDA Office of Medical Products and Tobacco, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.
Organizations in this story

FDA Office of Medical Products and Tobacco 10903 New Hampshire Ave NE Silver Spring, MD - 20903