Labeling Changes Planned for Simvastatin
The FDA) has announced labeling changes for simvastatin (Drug Zocor®, Merck), a cholesterol-lowering drug, as a result of The Heart Protection Study (HPS) findings. The new labeling will indicate that simvastatin is effective in reducing the risk of fatal and nonfatal heart attacks and strokes and in reducing the need for bypass surgery and angioplasty.
In the study, the risk of death from coronary heart disease was reduced by 18% in the patients receiving simvastatin, and their risk of their having a nonfatal heart attack was reduced by 38%. Sim-vastatin also reduced the risk of stroke by 25% and the need for coronary or non-coronary revascularization procedures to unblock clogged arteries by 30% and 16%, respectively. Patients who had diabetes, peripheral vessel disease, and cerebrovascular disease but no evidence of heart disease also appeared to benefit from taking simvastatin.
As with other statins, simvastatin medication should be used in conjunction with a standard cholesterol-lowering diet. The dosage range is 5 to 80 mg/day.
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 sim-vastatin in the study were observed with the 40-mg dose, lower doses are recommended for those taking certain medications (e.g.,drug cyclosporine, verapamil generic, amiodarone medication, and other cholesterol-lowering drugs) and in patients with kidney problems.
