Cholesterol Medication Increases Risk of Muscle Injury
-The popular cholesterol medication Simvastatin (Zocor) can increase the risk of muscle injury when used at the highest dose; 80 mg. This is according to an alert released by the United States Food and Drug Administration.
The agency reported on data from the recent large clinical trial named SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine). The SEARCH trial evaluated the number of major cardiac events such as heart attack, heart bypass surgery and death from heart attack in 6031 patients who were taking 80 mg of simvastatin (Zocor) verses 6033 patients taking 20 mg of simvastatin (Zocor) and followed the study subjects for over six years.
According to the alert, more patients in this trial who were taking the higher 80 mg dose of simvastatin (Zocor) developed muscle injury compared with patients taking the lower dose. There were 52 people who had cases of muscle injury out of the 6,033 people who were taking the higher dose. There was only one cases of muscle injury in the patients taking the lower 20 mg dose.
Additionally, in the group taking the higher dose medication, there were 11 cases of rhabdomyolysis, a condition of generalized muscle breakdown that can lead to kidney failure.
This warning is not a surprise. Muscle breakdown and rhabdomyolysis are known complications of these cholesterol medications known as Statins. These include the popular cholesterol medication Lipitor (Atorvastatin), and Crestor. However, this study was unique in that it showed a dose-related risk for the medication. We also suspect that certain patients are more likely than others to experience muscle pain. This will sometimes improve with a lower dose of a stronger statin medication. We also suspect that adequate hydration is helpful at preventing muscle pain from the statin medications.
Cristopher Geiler, MD
Reference
http://www.fda.gov/medwatch
Posted on March 23, 2010
