New Cholesterol-Lowering Drugs Near FDA Approval

They are very effective add-on therapy to statins

New Cholesterol Lowering Drugs

Two new drugs to help physicians better manage “bad” cholesterol (LDL cholesterol) have received approval this week from an FDA advisory panel. The FDA typically accepts those recommendations, so the drugs may soon be available for patient use.

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The new drugs – both injectables – are called alirocumab (brand name, Praluent), which received the panel’s approval on Tuesday, and evolocumab (brand name, Repatha), which received it on Wednesday.

Steven Nissen, MD, Chairman of Cardiovascular Medicine at Cleveland Clinic, calls these two new drugs very powerful, saying they lower bad cholesterol levels by 50 to 70 percent.

“This is a breakthrough in how we treat cholesterol. It is probably the most important new class of drugs that we have seen in cardiology in quite a long time,” he says “It is going to generate a lot of interest and excitement, and for good reason.”

LDL cholesterol is a major contributing factor to coronary heart disease, perhaps the most important one.

Dr. Nissen says the two drugs are very similar to one another. The biggest difference is that their recommended dosing schedule ‒ one can be given either every two weeks or every four weeks, and the other is given every two weeks.

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“I don’t think there is an advantage of one over the other,” he says.

Best uses

He notes that these drugs will not replace statin drugs such as Lipitor, Zocor and Crestor, but be used in addition to them.

“We are not going to be taking patients off of statin drugs in order to give these drugs. It would not makes sense to withhold drugs that have been shown to have a major benefit in order to give these new drugs,” he says.

“However, these are for patients who cannot tolerate statins or who cannot take enough of them to get their LDL cholesterol down to optimal levels. These drugs will be very valuable for those difficult-to-treat patients,” he says.

Another drug in the pipeline

Cleveland Clinic has been involved in many of the trials in the development of these new cholesterol-lowering drugs. Dr. Nissen is leading a 1,000 patient study of evolocumab to learn if the drug can actually remove plaques from coronary arteries. That is expected to be complete sometime next year.

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He also is on the steering committee for a trial with a third drug in the class being developed by Pfizer. This drug – bococizumab ‒ is expected to be presented for FDA approval later this year.

Questions remain

While it is known that alirocumab and evolocumab are very effective in reducing cholesterol, Dr. Nissen notes that are there still some questions to be answered about them.

“Clinical outcome trials to determine whether or not they reduce the risk of the things that we really care about, like heart attack, stroke, and death, have not been completed yet, but those studies are ongoing. However, many people expect them to have a favorable effect,” he says.

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