PCSK-9 Inhibitors Move the Needle

“Over the last several years, the most important new medications to come out are PCSK-9 inhibitors,” said Peter Dionisopoulos, MD, medical director of the Cardiovascular Health and Lipid Clinic at the Nebraska Heart Institute.

Guidelines indicate this class of drugs for patients with familial hypercholesterolemia.

“The total cholesterol is over 300 and sometimes as high as 500,” said Dr. Dionisopoulos. “The LDL or bad cholesterol will be in excess of 200. These individuals are at extremely high risk for developing premature atherosclerosis.”

PCSK-9 inhibitors are also for individuals who cannot tolerate statins because of side effects like muscle aches. Clinical trials have found that 2 to 3 percent of patients don’t tolerate statins.

However, those trials weaned out individuals who were intolerant before they were even prescribed the medication, said Dr. Dionisopoulos. “I think clinically, it’s more on the order of 5 to 10 percent of individuals who can’t tolerate statins.”

Patients who have had documented atherosclerosis or plaquing are also indicated for PCSK-9 inhibitors.

“They have either had a stent or a heart attack or a bypass surgery, or they have disease elsewhere in the body, whether its carotid artery stenosis or peripheral artery disease in the legs,” said Dr. Dionisopoulos.

The only drawback is cost and insurance coverage, because the medications are new. But the results have been striking.

“We’ve seen cholesterol reductions up to 70 percent,” he said. “In the clinical trials, there were no significant side effects.  Since it’s a specifically modified molecule that binds to the PCSK-9, it doesn’t cause muscle pain, memory issues or liver toxicity.”