Cholesterol drug simvastatin saves lives and improves quality of survival
February 8, 2002 | 12:00am
Findings from Heart Protection Study, the worlds largest clinical study ever conducted, showed simvastatin saved lives and significantly lowered the risk of heart attack and stroke in a broad range of high-risk patients. These benefits were shown in all high-risk patients, including patients with average or below-average cholesterol levels. In addition, for the first time ever, the study demonstrated the life-saving benefits of simvastatin for several distinct, at-risk patient populations, including diabetes patients, stroke victims, women and elderly.
The preliminary results of the 20,536-patient study, conducted by world-renowned Oxford University, U.K., showed that simvastatin taken for an average of 5.5 years duration reduced the risk of heart attack and stroke by about one-fourth - regardless of the patients sex, age or cholesterol level. When adjusted for non-compliance, Oxford University estimates that the risk reduction among this broad population is one-third.
With more than 6,000 diabetes patients enrolled in Heart Protection Study, it is the first study designed to investigate the benefits of cholesterol-lowering therapy in Type I and Type II diabetics with or without a prior history of heart disease or high cholesterol. The incidence of CHD events among the nearly 4,000 diabetic patients with no prior CHD was about a quarter lower in the patients allocated simvastatin vs. those in the placebo group. When adjusted for non-compliance, Oxford reports that the incidence of events were approximately a third lower. About five years of treatment with simvastatin typically prevents heart attacks, strokes or other major vascular events in 70 out of 1,000 patients with diabetes, aged 40 or older.
The World Health Organization estimates that, worldwide, there will be a two-fold increase in the number of diabetic patients to 300 million by 2025. According to Dr. Dante Morales, a well respected Filipino heart specialist , the Heart Protection Study offers important new clinical insights for physicians who treat patients with diabetes which is now reaching epidemic proportions.
Patients with average or low cholesterol levels also achieved risk reductions of about a quarter and when adjusted for non-compliance, Oxford researchers estimate that the risk of heart attack and stroke would be reduced by one third. Physician and lipid researcher Roger Illingsworth said, "Heart Protection Study amplifies and extends the benefits of simvastatin to more patients, particularly those patients with low cholesterol levels and the elderly. This study showed that - for patients with high-risk factors - simvastatin provided significant benefits, and that patients could live longer if they lower their LDL cholesterol levels with simvastatin." For all patients in Heart Protection Study, no matter what their cholesterol level, the risk of vascular events was reduced by a quarter, or one-third with full compliance.
The results from the Heart Protection Study offered additional and conclusive evidence of the excellent safety profile of simvastatin, which has been demonstrated in more than 15 years of clinical experience. The Heart Protection Study demonstrated no significant difference in liver enzymes elevations between the 10,269 patients taking simvastatin and the 10,267 patients taking placebo. The incidence of significant muscle enzyme elevation, indicating possible muscle damage, was extremely low in both groups- only nine out of more than 10,000 patients on simvastatin and five in the placebo group. Simvastatin was shown to be very well tolerated and provide significant benefits in all high-risk patients - regardless of age, sex and cholesterol levels.
The preliminary results of the 20,536-patient study, conducted by world-renowned Oxford University, U.K., showed that simvastatin taken for an average of 5.5 years duration reduced the risk of heart attack and stroke by about one-fourth - regardless of the patients sex, age or cholesterol level. When adjusted for non-compliance, Oxford University estimates that the risk reduction among this broad population is one-third.
The World Health Organization estimates that, worldwide, there will be a two-fold increase in the number of diabetic patients to 300 million by 2025. According to Dr. Dante Morales, a well respected Filipino heart specialist , the Heart Protection Study offers important new clinical insights for physicians who treat patients with diabetes which is now reaching epidemic proportions.
The results from the Heart Protection Study offered additional and conclusive evidence of the excellent safety profile of simvastatin, which has been demonstrated in more than 15 years of clinical experience. The Heart Protection Study demonstrated no significant difference in liver enzymes elevations between the 10,269 patients taking simvastatin and the 10,267 patients taking placebo. The incidence of significant muscle enzyme elevation, indicating possible muscle damage, was extremely low in both groups- only nine out of more than 10,000 patients on simvastatin and five in the placebo group. Simvastatin was shown to be very well tolerated and provide significant benefits in all high-risk patients - regardless of age, sex and cholesterol levels.
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