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'Very Low' Risk From Statin Cholesterol Drugs

Study Says Kidney and Muscle Damage Seen Mostly in People Vulnerable to Those Problems
By
WebMD Health News

May 23, 2005 -- Statin drugs, which lower dangerous cholesterol levels, have "very low risk" of kidney and severe muscle side effects, says Richard Karas, MD, PhD.

However, among available statins -- Crestor, Lipitor, Pravachol, and Zocor -- the FDA received more reports of those problems with Crestor during the drug's first year on the market, says Karas and colleagues in the online edition of Circulation.

Karas, who directs the Preventive Cardiology Center and the Women's Heart Center at Boston's Tufts-New England Medical Center, talked about the study at a news conference.

The news needs a big dose of perspective, he and other doctors said at the news conference. Those side effects were extremely rare and people should not stop taking their statin drugs without first consulting their physicians, they said.

'Very Safe' Drugs

High cholesterol is a major heart hazard, and heart disease is a leading cause of death for U.S. men and women. There are many steps to take to lower cholesterol, including a healthy diet and exercise. Millions of people also take medications to curb their cholesterol.

"Statins in general are very safe," said Scott Grundy, MD, PhD, at the news conference. "These can be lifesaving to high-risk patients."

Grundy works at the Center for Human Nutrition and the departments of clinical nutrition and internal medicine at the University of Texas Southwestern Medical Center in Dallas. He wrote an editorial for Circulation about the study.

"Statins are among our best drugs for treating individuals who have elevated cholesterol," says American Heart Association president Alice Jacobs, MD, in a news release. "This study should reassure the public that the drugs are safe. Overwhelmingly, the majority of individuals tolerate statins very well and the absolute risk of side effects is low, including for [Crestor]."

Crestor's Maker Reacts

AstraZeneca, the maker of Crestor (and a WebMD sponsor) issued a press release on Monday night about the study.

The release says the study's conclusions are "misleading, and unfortunately create unnecessary alarm for patients who need this medication to lower their cholesterol."

AstraZeneca says the study "attempts to draw conclusions that simply cannot be drawn from adverse event reporting data," and that the company stands "fully" behind Crestor's safety and effectiveness when the drug is used according to prescription information. Crestor has been prescribed almost 22 million times for more than 4.7 million patients, says AstraZeneca.

Screening Recommended Before Prescription

Most of the muscle and kidney side effects occurred in people who were particularly vulnerable to those problems and generally went away when the medications were stopped, said Grundy. He encourages doctors to screen for risk factors before prescribing any statin.

Patients should also talk to their doctors about any issues that come up, such as brown urine, an indication that muscle damage or liver problems may be occurring. Also, "very dramatic [muscle pain] that doesn't go away" is something Karas recommends that patients should discuss with their doctors. Those may be symptoms of a severe and potentially fatal condition called rhabdomyolysis, in which massive muscle damage occurs.

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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

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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