THURSDAY, April 17, 2003 (HealthDayNews) -- The anti-cholesterol drug Zocor (simvastatin) is effective in reducing the risks of heart attacks, strokes and the need for bypass surgery and angioplasty -- even in people whose cholesterol isn't above normal levels, the U.S. Food and Drug Administration says in approving new labeling for the drug.
Approval was based on a 20,000-person clinical trial known as the Heart Protection Study. Participants' risk of death from coronary heart disease fell by 18 percent; the risk of having a non-fatal heart attack was reduced by 38 percent; and the risk of stroke dropped 25 percent. The need for procedures to unblock clogged arteries fell by as much as 30 percent, the FDA says.
The decreases were seen among people of all ages and baseline cholesterol levels, the agency adds. And it didn't matter if participants had heart disease or diabetes.
The FDA reminds people who take Zocor to be aware of any muscle pain, which may indicate a serious side effect called rhabdomyolysis, a muscle breakdown disorder. Symptoms can begin as fatigue, fever, nausea and vomiting, severe muscle pain, weakness and tenderness, and end up as cardiac arrest or heart attack.
Here is the FDA Talk Paper about the approval. For more information about Zocor, visit the National Library of Medicine.
