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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

Conditions That Carry Higher Risk of Muscle Damage

The following conditions are listed as carrying a higher risk of muscle damage from statin drugs, which require either avoidance of the drugs or use of a lower dose:

  • Older age, especially greater than 80 (women more than men)
  • Small frame and frailty
  • Multiple chronic medical conditions, such as chronic kidney failure (especially with diabetes)
  • Use of multiple medications that may change the metabolism of the statin drug, especially antifungal drugs
  • People who drink large amounts of grapefruit juice (more than one quart per day), which alters the metabolism of statin drugs
  • Alcohol abuse

Because each person is different, doctors and patients should know and discuss the risks and benefits before choosing a statin, Grundy told reporters. Cholesterol-lowering statin drugs include information about possible rare muscle or kidney problems in their prescription information; the possible risk isn't a new discovery.

Study's Findings

Karas and colleagues looked at muscle and kidney problems reported to the FDA during Crestor's first year on the market (starting in the latter half of 2003).

During that time, there were 28 such side effects per million Crestor prescriptions, 13 per million Zocor prescriptions, 3.5 per million Pravachol prescriptions, and 4.3 per million Lipitor prescriptions, says Karas.

Deaths were extremely rare for all of the statins.

Because reported side effects might be different during a drug's first year, they also checked reports for the three older drugs -- Pravachol, Lipitor, and Zocor -- in their first year of release. Crestor's number was higher than those drugs during their first year but lower than that of another statin, Baycol, which was pulled form the market in 2001.

Baycol was taken off the market because of concerns about deaths related to rhabdomyolysis.

FDA and Crestor

In March, the FDA issued a public health advisory about Crestor's potential risks and benefits. That followed a January 2005 report by AstraZeneca that a patient died while taking Crestor.

After an extensive review, the FDA said that patients taking recommended doses of Crestor had a similar risk of rhabdomyolysis as other statin drugs. Grundy praised the FDA's review in his editorial.

In March, an AstraZeneca news release said the FDA's letter stated that "all of the available evidence indicates that Crestor does not pose a risk of muscle toxicity greater than the other approved statins, and that with respect to renal toxicity, there is no convincing evidence that Crestor poses a serious risk of renal injury.

"Recently, the FDA approved revisions to the Crestor prescribing information, which strengthened language around the appropriate use of Crestor," the release continues. "At the same time, the FDA issued a statement confirming that the potential benefits of Crestor outweigh the potential risks when taken as directed."

Is This Normal? Get the Facts Fast!

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Desirable
0-199
Borderline
200-239
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240+

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

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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