The major FDA-approved uses for Mevacor are to reduce the risk in individuals without symptomatic cardiovascular disease, and with moderately elevated cholesterol levels, of heart attack, unstable angina (chest pain), and the need for coronary revascularization procedures such as angioplasty or heart bypass surgery.
Pravachol was approved by the FDA as the primary drug for individuals without clinically evident coronary heart disease to reduce the risks of heart attack, revascularization procedures such as angioplasty and heart bypass surgery, and cardiovascular mortality, without increasing the risk of death from noncardiovascular causes.
Pravachol is also approved for the secondary prevention of cardiovascular events. Secondary prevention refers to reducing the risk of a serious outcome in individuals who already have clinically evident coronary heart disease. Pravachol is approved to reduce the risk of coronary death, heart attack, coronary revascularization procedures, stroke and stroke/transient ischemic attack (TIA), and to slow the progression of coronary atherosclerosis.
The FDA has approved Zocor for use in individuals at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke, or other cerebrovascular disease. In this group of patients this statin is approved to reduce the risk of coronary heart disease death, nonfatal heart attack and stroke, coronary and noncoronary revascularization procedures.
Lipitor has been approved for use in adult patients who either have clinically evident coronary heart disease or multiple risk factors for coronary heart disease, to reduce the risk of heart attack (myocardial infarction), stroke, angina, and to reduce the need for certain surgical procedures such as angioplasty or bypass surgery that restore blood flow to the heart or other organs (revascularization). In addition, for patients who have coronary heart disease, the drug is approved to reduce the risk of hospitalization for congestive heart failure.
A Patient Package Insert was added to the Lipitor product label to provide patients with information about taking this drug.
In early 2003, a highly publicized study comparing a high dose of Lipitor to a standard dose of Pravachol (PRAVACHOL) found that Lipitor was better in reducing a combination of adverse cardiovascular events in people who had recently been hospitalized with a heart attack or angina. Although this combination of subsequent events was reduced by Lipitor (compared with Pravachol), there was no significant reduction in the incidence of heart attacks alone or strokes alone.
In 2006, the FDA revised the professional product label of Lipitor to include information from a large study that examined the effects of statin drugs on patients who had a recent stroke. The study showed that patients taking Lipitor who had a hemorrhagic stroke within the six months preceding the study appeared to be at an increased risk for hemorrhagic stroke compared to patients who taking a dummy pill with no medicinal value, known as a placebo.
The consumer’s “gold standard” for knowing the health benefits, if any, of a prescription drug is the FDA-approved professional product labeling for that drug. It is clear from the FDA-approved labeling for the statins that Mevacor, Pravachol, Zocor, and Lipitor should be used in preference to rosuvastatin (CRESTOR) or fluvastatin (LESCOL) because of acceptable scientific evidence of a health benefit, rather than just the ability to lower cholesterol.
The statin drugs appear to share psychiatric risks with other cholesterol-lowering drugs. Aggressive behavior; memory impairment; mood changes; and cognitive, sleep and perception disorders, such as nightmares, have been reported with the use of many drugs used to treat high cholesterol: the statins, fenofibrate (TRICOR), gemfibrozil (LOPID), ezetimibe (ZETIA) , and clofibrate, Though researchers have not yet established a direct link between these reports and the use of the cholesterol-lowering drugs listed, patients should be alert to this possibility and report unexpected changes to their doctor. Potentially, statin-induced memory impairment could be mistaken for other conditions such as early Alzheimer’s disease. This could result in the prescribing of a drug to treat Alzheimer’s when it is not needed.
In the October 2005 issue of the Canadian Adverse Reaction Newsletter, 19 case reports of memory loss or impairment associated with the use of a cholesterol-lowering statin drug were analyzed. Potentially, statin-induced memory impairment could be mistaken for other conditions such as early Alzheimer’s disease. This could result in the prescribing of a drug to treat Alzheimer’s when it is not needed.