Results of an analysis of the Heart Protection Study, the largest-ever study using a cholesterol-modifying medication, published in this week's issue of The Lancet demonstrated that treatment with Zocor (simvastatin) 40 mg reduced the incidence of stroke by 25 per cent (Zocor 40 mg 444/10,269 versus 585/10,267 for placebo p=<0.0001) among patients who had coronary heart or other occlusive arterial disease (arterial blockage), or diabetes, regardless of baseline cholesterol, age or sex.
Analyses were pre-specified of first 'major vascular event' (i.e., stroke of any type, non-fatal myocardial infarction or coronary death, or any revascularization procedure) in prior disease subcategories. The patients in the Heart Protection Study experienced a benefit of a 24 per cent reduction in risk of a major vascular event and a 25 per cent reduction in risk of stroke.
Patients who had pre-existing cerebrovascular disease at study entry experienced a significant 20 per cent reduction in rate of any major vascular events, with a 25 per cent reduction among the other high-risk participants.
"Overall, treatment with Zocor 40 mg produced a highly significant 24 percent reduction in first major vascular event in these patients," said Lori Mosca, director of Preventive Cardiology, New York Presbyterian Hospital and associate professor of Medicine at Columbia University.
"Stroke is a leading cause of serious, long-term disability in the United States and for the victims of stroke and their families the impact can be devastating," stated Dr Mosca. According to the 2004 Update of the American Heart Association's Heart Disease and Stroke Statistics, each year an estimated 700,000 Americans experience a new or recurrent stroke. Stroke kills nearly 1 in 4 of those it strikes. "These findings from HPS show that Zocor can help reduce the risk of stroke in patients who are at high risk because of CHD or diabetes," said Dr Mosca.
In the five-year Heart Protection Study comprised of 20,536 patients, 3,280 adults with cerebrovascular disease, and an additional 17,256 patients with other occlusive arterial disease or diabetes who did not have cerebrovascular disease, were randomized to receive Zocor 40 mg or matching placebo. Comparisons were of all patients allocated to Zocor 40 mg versus all placebo-allocated patients which yielded an average difference in LDL cholesterol of 1.0 mmol/L (39 mg/dL) during the five-year treatment period. The mean duration of follow-up was five years.
Conducted by the Clinical Trials Service Unit (CTSU) of Oxford University, and funded in part by Merck, the Heart Protection Study aimed to assess the effects of a substantial reduction in LDL (bad) cholesterol on major vascular events, maintained for several years in at-risk groups, including a large group of individuals with coronary heart disease (CHD) or diabetes.