The Heart Protection Study, the largest-ever study using a cholesterol-modifying medication, demonstrated that taking ZOCOR 40 mg daily reduced the risk of first major coronary events[1] by 27 percent (ZOCOR 40 mg 279/2978 vs. 377/2985 for placebo, p<0.0001) in patients with diabetes with or without coronary heart disease. The Heart Protection Study is the first study designed to investigate the benefits of therapy with ZOCOR 40 mg in people with Type I and Type II diabetes with or without a prior history of heart disease or high cholesterol. The study included 5,963 people—about 29 percent of all people in the study—with diabetes (of all patients studied 26 percent had Type II diabetes and 3 percent had Type I diabetes).

"The Heart Protection Study provides the first definitive evidence that therapy with simvastatin 40 mg, known as ZOCOR along with diet can produce reductions in the risk of heart attacks, of strokes and of revascularizations in people with diabetes, even if they do not already have diagnosed coronary or other cardiovascular disease," according to Alan J. Garber,M.D., Ph.D., chief of Endocrinology, Diabetes and Metabolism, The Methodist Hospital in Houston. "This new information could change the way physicians treat patients who suffer from diabetes. The data from the Heart Protection Study definitively show that patients treated with simvastatin 40 mg, known as ZOCOR, along with diet reduced the risk of heart attacks, strokes or other major vascular events with the greatest effect seen in diabetic patients without heart disease."

Most people with diabetes are not currently receiving therapy to manage their increased risk. The primary focus for most diabetes patients is on blood-glucose control, which is critical because it reduces the risk of microvascular complications such as eye, kidney and nerve damage. This study showed that another consideration should be treatment with ZOCOR 40 mg, which has been shown to reduce the risk of heart attack and stroke in people with diabetes regardless of blood-glucose levels. For physicians treating people with diabetes, the Heart Protection Study results support starting appropriate patients on ZOCOR 40 mg along with diet, regardless of their cholesterol or blood sugar levels.

The safety profile of ZOCOR 40 mg was comparable to placebo in the Heart Protection Study
During the five-year Heart Protection Study, the overall safety profiles were comparable between patients treated with ZOCOR 40 mg and patients treated with placebo. The number of patients who discontinued the study due to adverse reactions was also comparable (4.8 percent for people on ZOCOR and 5.1 percent for people on placebo). In this trial, only serious adverse effects and discontinuations due to any adverse effects were recorded. The incidence of myopathy/rhabdomyolysis was <0.1 percent in people on ZOCOR 40 mg.

ZOCOR lowered LDL cholesterol, reduced incidence of coronary and vascular events
An average reduction in LDL cholesterol of 39 mg/dL during the trial lessened the risk of major vascular events[2] by 22% (ZOCOR 40 mg 601/2978 vs. 748/2985 for placebo, p<0.0001) in the participants with diabetes (which was similar to the reduction seen among the patients without diabetes), regardless of any pre-existing cardiovascular disease, age, sex, lipid concentrations or glycaemic control. The average baseline LDL cholesterol level was 124 mg/dL at the start of the study.

"Until the Heart Protection Study data became available, evidence about the effects of lowering cholesterol in individuals with diabetes was limited," Dr. Garber said. "The Heart Protection Study now shows that lowering LDL cholesterol with simvastatin, known as ZOCOR from below 116 to below 77mg/dL in people with diabetes reduces the risk of major vascular events."

Among the study participants with diabetes, those given ZOCOR 40 mg produced a 27 percent (ZOCOR 40 mg 279/2978 vs. 377/2985 for placebo, p<0.0001) risk reduction in the incidence of first non-fatal heart attack and coronary death compared to those given a placebo. This represented a 37 percent (ZOCOR 40 mg 105/2978 vs. 164/2985 for placebo, p=0.0002) reduction in risk of first non-fatal heart attack. The regimen with ZOCOR 40 mg produced a 24 percent (ZOCOR 40 mg 149/2978 vs. 193/2985 for placebo, p=0.01) risk reduction in the incidence of first non-fatal or fatal stroke. Among the diabetic participants there was also a 17 percent reduction (ZOCOR 40 mg 260/2978 vs. 309/2985 for placebo, p=0.02) in the incidence of first revascularization procedure versus placebo-allocated patients.

"Based on the results of the Heart Protection Study, decisions about whether to initiate cholesterol therapy in patients with diabetes should now recognize that these individuals are at an extremely high risk of suffering either a heart attack or a stroke, or needing some major revascularization procedure," Dr. Garber said. "Treatment with simvastatin 40 mg should now be considered along with diet for all appropriate patients with diabetes, who are at high risk for major vascular events, regardless of their blood glucose levels."

Selected cautionary information about ZOCOR
ZOCOR should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. Muscle pain or weakness in patients taking ZOCOR should be reported to a doctor, because these could be signs of a serious side effect. Doctors may perform blood tests before and periodically during treatment with ZOCOR to check for liver problems. Patients taking the 80 mg strength of ZOCOR should receive an additional liver function test at three months. To help avoid serious side effects, discuss with your doctor medicine or food you should avoid while taking ZOCOR. In clinical trials, adverse reactions usually have been mild and transient. Most common side effects included headache (3.5 percent), abdominal pain (3.2 percent) and constipation (2.3 percent).