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How to Reduce Cholesterol: New Medication Options

In trials, PCSK9 inhibitors dramatically lower LDL cholesterol  levels. Researchers believe these new cholesterol medications may reduce the risk of death from heart attack, stroke and other cardiovascular issues as well. One drug has been approved, and another is under review by the FDA and should be available soon.

patient talking to physician holding pill bottle

“I’m very optimistic about PCSK9 inhibitors,” says Johns Hopkins cardiologist Seth Martin, M.D., M.H.S. “While existing evidence is strong, I would like to see more long-term studies.”

With that in mind, Martin recommends reviewing these key questions and answers about PCSK9 inhibitors and how to reduce cholesterol with your doctor.

What are PCSK9 inhibitors?

PCSK9 inhibitors are a new class of LDL (low-density lipoprotein) cholesterol-lowering medications, delivered via self-injection, typically every two weeks. PCSK9 inhibitors prevent the liver’s LDL receptors, which regulate and clear cholesterol from the bloodstream, from degrading. That’s essentially the same thing statins—the most popular class of cholesterol drugs—do to reduce cholesterol. But in trials, the new PCSK9 inhibitors do it better.  

Who could benefit from PCSK9 inhibitors?

Potentially, anyone with high LDL cholesterol levels could benefit. The early focus will be on three groups:

  1. Those with familial hypercholesterolemia, a genetic condition impacting about 1 in 300 Americans. Statins and other treatments do not lower LDL cholesterol enough for these folks.
  2. Those with high cardiovascular risk, such as those who’ve had a heart attack or stroke at a relatively young age.
  3. Those who have statin intolerance—typically muscle pains that prevent statin use or restrict use to lower-intensity statins. But, Martin says, the FDA may not approve this indication, due to the difficulty of defining statin intolerance.

What will PCSK9 inhibitors cost?

The price is a key reason PCSK9 inhibitors may not be for everybody. Martin suspects they will cost $10,000 to $12,000 annually, compared to as little as $4 a month for generic statins.

“Whether they are a financially viable option for folks will depend on insurance,” Martin says. “How much are the co-pays? How restrictive is it to get them approved? We don’t yet know. There is a third party acting on behalf of patients to help facilitate the process, and the PCSK9 companies are providing a bridging program.”

What risks are associated with PCSK9 inhibitors?

Trials to date have shown no significant risks associated with PCSK9 inhibitors. Everything looks good, Martin says, but some questions remain unanswered:

  1. What is the long-term impact of very low-level LDL cholesterol, and how often will patients have to come in for monitoring?
  2. Are there any side effects or interactions with other drugs? So far, no, Martin says, but there is more to learn.
  3. Do PCSK9 inhibitors prevent cardiac events such as heart attacks? Research suggests they do, but Martin says none of the studies were specifically designed to look at deaths or heart attacks.

“The bottom line is, we’ll have a lot more data as times goes on,” Martin says. “It’s the art of medicine, the balance of risks and benefits. And folks might want to wait a while if they’re not high-risk.”

Research Shows

Could PCSK9 Inhibitors Add Years to Life?

In a meta-analysis of multiple trials covering more than 10,000 patients, German researchers found that the treatment of high cholesterol with PCSK9 inhibitors reduced the risk of death from all causes, including cardiovascular death, compared to those treated with traditional statin therapies. PCSK9 inhibitor-treated patients also showed lower LDL cholesterol levels. Johns Hopkins cardiologist Seth Martin, M.D., M.H.S., and colleagues wrote the editorial comment on the meta-analysis for the Annals of Internal Medicine and expressed enthusiasm that we are entering a new era of cholesterol treatment. “There is a critical need for this new therapeutic option,” says Martin.

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