Merck Co Inc announced that the Food and Drug Administration (FDA) has approved changes to the prescribing information for Zocor (simvastatin) to include results from the landmark Heart Protection Study with Zocor 40 mg, the largest cholesterol treatment study ever conducted.
As a result of the FDA's decision, Zocor 40 mg is now recommended, along with diet, as the starting dose for Zocor for people with coronary heart disease (CHD) or diabetes. Zocor 40 mg is the first and only cholesterol-lowering medication proven to reduce the risk of heart attack and stroke in people with heart disease or diabetes regardless of cholesterol level. Treatment with Zocor 40 mg as compared to placebo reduced the risk of death from any cause by 13 percent (Zocor 1328/10269 vs. placebo 1507/10267, p=0.0003).
"The new use has the potential to change the treatment approach of people with CHD and those with diabetes. It demonstrates that the millions of people who suffer from CHD or diabetes could benefit from treatment with simvastatin 40 mg known as Zocor," said Alan J. Garber, chief of Endocrinology, Diabetes and Metabolism, The Methodist Hospital in Houston. "This news is particularly relevant in light of the latest NCEP Guidelines, which call for aggressive treatment of patients at high-risk for heart attacks such as people with diabetes or CHD."