Zocor Essay, Research Paper

ZOCOR has been available in the United States since 1992, and ZOCOR has been prescribed for more than 6 million patients worldwide.

Background A team of doctors and scientists designed a large-scale, long-term study to determine whether ZOCOR (simvastatin), a cholesterol-lowering medicine, as an addition to diet, could help heart disease patients with high cholesterol live longer and avoid heart attacks. The study took about 6 years and involved 4,444 patients with coronary heart disease and high cholesterol. Clinical trials were concluded in August of 1994, and the results were made public in November of 1994.

Results The study revealed that treating these patients with ZOCOR lowered their risk of heart attack and death. In statistical terms, ZOCOR: reduced heart attacks by 34% reduced the need for heart surgery by 37% reduced deaths from heart attack by 42%

USES OF ZOCOR

ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high cholesterol when diet and exercise are inadequate. For patients with coronary heart disease (CHD) and high cholesterol, ZOCOR is indicated as an addition to diet to reduce the risk of death by reducing coronary death; to reduce the risk of heart attack; and to reduce the risk for undergoing cardiac procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty).

WHEN ZOCOR SHOULD NOT BE USED

Some people should not take ZOCOR. Discuss this with your doctor.

ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a preservative.

Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.)

Women who are or may become pregnant: Pregnant women should not take ZOCOR because it may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once.

Women who are breast-feeding should not take ZOCOR.

WARNINGS

Liver: About 1% of patients who took ZOCOR in clinical trials developed elevated levels of some liver enzymes. Patients who had these increases usually had no symptoms. Elevated liver enzymes usually returned to normal levels when therapy with ZOCOR was stopped.

In the ZOCOR Survival Study, the number of patients with more than one liver enzyme level elevation to greater than 3 times the normal upper limit was no different between the ZOCOR and placebo groups. Only 8 patients on ZOCOR and 5 on placebo discontinued therapy due to elevated liver enzyme levels. Patients were started on 20 mg of ZOCOR, and one third had their dose raised to 40 mg.

Your doctor should perform routine blood tests to check these enzymes before you start treatment with ZOCOR and periodically thereafter (for example, semiannually) for your first year of treatment or until one year after your last elevation in dose. If your enzyme levels increase, your doctor should order more frequent tests. If your liver enzyme levels remain unusually high, your doctor should discontinue your medication.

Tell your doctor about any liver disease you may have had in the past and about how much alcohol you consume. ZOCOR should be used with caution in patients who consume large amounts of alcohol.

Muscle: Tell your doctor right away if you experience any muscle pain, tenderness, or weakness at any time during treatment with ZOCOR, particularly if you have a fever or if you are generally not feeling well, so your doctor can decide if ZOCOR should be stopped. Some patients may have muscle pain or weakness while taking ZOCOR. Rarely, this can include muscle breakdown resulting in kidney damage. The risk of muscle breakdown is greater in patients taking certain other drugs along with ZOCOR, such as the lipid-lowering drug Lopid* (gemfibrozil), a fibrate; lipid-lowering doses of nicotinic acid (niacin); the antibiotics erythromycin and clarithromycin; nefazodone; antifungal drugs that are azole derivatives, such as itraconazole and ketoconazole; or drugs that suppress the immune system (called immunosuppressive drugs, such as Sandimmune** [cyclosporine]). Therapy with ZOCOR should be temporarily interrupted if you are going to take an azole derivative antifungal medication, such as itraconazole. Patients using ZOCOR along with any of these other drugs should be carefully monitored by their physician. The risk of muscle breakdown is greater in patients with kidney problems or diabetes.

If you have conditions that can increase your risk of muscle breakdown, which in turn can cause kidney damage, your doctor should temporarily withhold or stop ZOCOR. Such conditions include severe infection, low blood pressure, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures. Also, since there are no known adverse consequences of briefly stopping therapy with ZOCOR, treatment should be stopped a few days before elective major surgery. Discuss this with your doctor, who can explain these conditions to you.

Because there are risks in combining therapy with ZOCOR with lipid-lowering doses of nicotinic acid (niacin) or with drugs that suppress the immune system, your doctor should carefully weigh the potential benefits and risks. He or she should also carefully monitor patients for any muscle pain, tenderness, or weakness, particularly during the initial months of therapy and if the dose of either drug is increased. Your doctor may also monitor the level of certain muscle enzymes in your body, but there is no assurance that such monitoring will prevent the occurrence of severe muscle disease.

ZOCOR is less effective in patients with the rare disorder known as homozygous familial hypercholesterolemia.

Pediatric Use: ZOCOR is not recommended for children or patients under 20 years of age.