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Biologic Drug Lowers LDL Cholesterol

Experimental Drug Lowers LDL on Top of Traditional Statin
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WebMD Health News
Reviewed by Laura J. Martin, MD

March 26, 2012 (Chicago) -- An experimental biologic drug called REGN727 may help lower levels of LDL ("bad") cholesterol when a statin drug isn't enough, researchers report.

In a new study, REGN727 (which does not have a brand name yet) cut LDL cholesterol by up to 72% when given in addition to the statin Lipitor.

That study, presented at the American College of Cardiology's annual meeting, included about 180 people with LDL cholesterol levels of at least 100 mg/dL. For 12 weeks, they took Lipitor and got injections of REGN727 or a placebo.

In people who got 50 milligrams of the drug injected once every two weeks, LDL levels dropped by 40%. And in people who got 100 milligrams every two weeks, LDL levels fell by 64%. The most effective dose was 150 milligrams every two weeks, which lowered LDL by 72%.

In contrast, LDL levels dropped only 5% in people who got the placebo.

The researchers also tested two once-monthly doses of the drug, but they didn't work as well as the every-two-weeks injections, says study head James McKenney, PharmD, chief executive officer of National Clinical Research in Richmond, Va.

"This is a 'wow' study," says Rick Nishimura, MD, a heart specialist at the Mayo Clinic, who was head of the committee that chose which studies to highlight at the meeting. "It takes us to a whole new level of cholesterol control and could be a game changer in the future," he tells WebMD. Nishimura was not involved with the study.

How It Works

The new drug works differently than statins do. It inhibits a protein called PCSK9. This, in turn, clears LDL cholesterol from the bloodstream.

Statin drugs work in a different way to remove LDL cholesterol from the bloodstream. While credited with making a substantial dent in heart disease, they don’t help everyone.

About 1 in 3 people with high LDL levels is resistant to statins or does not get enough benefit, leaving them at risk for heart attacks if they don't get additional treatment, McKenney says.

In the new study, REGN727 was generally safe, with mild infections and redness and soreness where the injection was given being the most common side effects. Serious side effects occurred in one person on placebo and in three people on the new drug, including one case of severe rash accompanied by diarrhea. Six people taking the drug stopped treatment due to side effects.

Another anti-PCSK9 drug -- currently called AMG 145 -- is also in development and, in an early study, lowered LDL levels when given in addition to a statin. At the meeting, Amgen presented findings from an earlier stage study of 51 people showing monthly injections of AMG 145 substantially lowered LDL when given on top of statins.

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Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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