|
|
|
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
|
T03-27 |
Media Inquiries: 301-827-6242 |
The Food and Drug Administration (FDA) today announced changes to the labeling for Zocor (simvastatin), based on the results of The Heart Protection Study (HPS). The new labeling will reflect research showing that simvastatin is effective in reducing risks of fatal and non-fatal heart attacks, strokes, and in reducing the need for bypass surgery and angioplasty. FDA approved Zocor in 1991 to lower cholesterol.
The Heart Protection Study was a double-blind, placebo-controlled study conducted in 20,536 patients. Men and women with heart disease or at high risk because of diabetes, peripheral arterial disease, or a history of stroke or other cerebrovascular disease were treated with either simvastatin 40 mg/day or placebo for an average of 5 years. The average age of patients entering HPS was 64 years and the average LDL-C (low density lipoprotein C, or “bad” cholesterol) level at baseline was 131 mg/dL. The trial population included a large number of diabetics and elderly patients.
The risk of death from coronary heart disease was reduced by 18 percent in the patients treated with simvastatin. The risk of having a non-fatal heart attack was reduced by 38 percent in this group. Simvastatin also reduced the risk of stroke by 25 percent and the need for undergoing coronary or non-coronary revascularization procedures (procedures to unblock clogged arteries) by 30 and 16 percent, respectively.
The effect of simvastatin to reduce the rate of cardiovascular events was seen in a number of relevant subpopulations of patients enrolled in the trial, including those with and without heart disease, diabetics and non-diabetics, and regardless of gender, age, or baseline cholesterol levels. An important observation in this trial was that patients who had diabetes, peripheral vessel disease, and cerebrovascular disease but who had no evidence of heart disease benefited from taking simvastatin.
Simvastatin has been shown to be effective in reducing total cholesterol and LDL cholesterol in familial and non-familial forms of hypercholesterolemia (high cholesterol) and in mixed hyperlipidemia –(elevations in both cholesterol and triglycerides).
As with other statins, Zocor should be used in conjunction with a standard cholesterol-lowering diet. The dose of Zocor should be individualized according to the goals of therapy and the patient’s response. The dosage range is 5-80 mg/day.
As with all statin drug products, patients should be aware of any muscle pain, which may indicate an adverse reaction called rhabdomyolysis, a muscle breakdown disorder. Symptoms can include fatigue, fever, nausea and vomiting, severe muscle pain, weakness and tenderness. Rhabdomyolysis can cause electrolyte imbalances that can result in heart rhythm problems, cardiac arrest, or heart attack. Although the beneficial effects of Simvastatin in HPS were observed with the 40 mg dose, lower doses are recommended in special populations such as those taking certain medications including cyclosporine, verapamil, amiodarone, and other cholesterol-lowering drugs and in patients with kidney problems.
Zocor is manufactured by Merck and Co., Inc. of Whitehouse Station, N.J.
####