VCU news

By Anne Dreyfuss
C. Kenneth and Dianne Wright Center for Clinical and Translational Research

Earlier this month, a panel of outside advisers recommended that the Food and Drug Administration approve a new cholesterol-lowering drug that blocks a protein called PCSK9, which interferes with the liver’s ability to clear bad cholesterol. While the FDA is not obliged to follow the advice of its advisory panels, it typically does. If approved, the new biotech drugs would be the first major addition to the list of cholesterol-lowering medicines since statins were first prescribed in the late 1980s.

“The PCSK9 inhibitors will have a major impact on how we manage lipid disorders and serve as an alternative approach for patients who do not tolerate statins,” said Dave Dixon, Pharm.D., assistant professor, Department of Pharmacotherapy and Outcomes Science, VCU School of Pharmacy.

Stay engaged with the conversation by following @VCUMedical on Twitter and searching for the hashtag #VCUHealthChat.

During a Twitter chat, Dixon answered questions about why someone would need to use cholesterol-lowering medications, how the new drugs are different from the previous options and more.

VCU will host a variety of Twitter chats with medical experts in the coming months. Stay engaged with the conversation by following @VCUMedical on Twitter and searching for the hashtag #VCUHealthChat.

Below are Dixon’s replies to some of the questions raised on Twitter.

 

Why would someone need cholesterol-lowering drugs?

These drugs are used for patients at risk of a heart attack or stroke.

What makes someone at risk?

Major risk factors include high blood pressure, smoking, age, family history and low “good” cholesterol. Those with inherited high cholesterol are at a very high risk for early heart disease without proper treatment. This class of agents will literally be a lifesaver for those suffering from inherited high cholesterol.

What is the difference between statins and PCSK9 medications?

Statins are our first-line agent to reduce risk, while the PCSK9 agents will be add-ons. Also, the PCSK9 agents will be injectable, while statins are tablets and taken by mouth.

Are the new PCSK9 drugs better than statins?

We have decades of evidence that statins reduce heart attacks and strokes. Also, PCSK9 will be much more expensive than statins. They are complementary drugs.

Will PCSK9 affect my liver or muscles like statins?

PCSK9 are highly specific. Studies have shown minimal effects on liver or muscles. This will be a major advantage for these drugs in patients unable to tolerate statins.

How is PCSK9 administered?

PCSK9 is a self-administered injection, similar to how patients administer insulin.

How often does PCSK9 need to be administered?

PCSK9 inhibitors have been administered every two weeks or once monthly in clinical trials.

How do PCSK9 drugs affect cholesterol levels?

PCSK9 drugs decrease “bad” cholesterol by 60 percent and lipoprotein (a) by 30 percent.

What patient population would you recommend the use of PCSK9 inhibitors for based on the current evidence?

Patients who are intolerant to statins, unable to reach goals on high-dose statins, or who have a family history of hypercholesterolemia would be good candidates for PCSK9 inhibitors.

Should the FDA approve PCSK9 inhibitors before clinical outcomes data is available?

I think the FDA should approve PCSK9 for patients at the highest risk and those with a family history of hypercholesterolemia. Of note, the long-term outcome studies will not have results until 2017, so I’d warrant caution in using these drugs in patients not at high risk.

 

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