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Back To Vidyya Simvastatin, Niacor ® Reduce Cardiac Events By 70% In Landmark Study

Separate Studies Find Niacin Safe, Effective Treatment For Diabetics With Coronary Heart Disease

ADMIT Study Finds Niacin a Safe, Effective Treatment for Diabetics with Dyslipidemia

It is estimated that more than 15 million people in the United States have diabetes, the seventh leading cause of death in this country. Individuals with low HDL ("good") cholesterol levels and high triglycerides are at greater risk to develop Type 2 Diabetes, which accounts for 90-95% of all diabetes cases. Diabetics are two- to four-times more likely than non-diabetics to suffer from heart disease, which contributes to 75% of diabetes-related deaths

To date, medical guidelines have not recommended the use of niacin for the treatment of high cholesterol and triglycerides in diabetics because of concerns about the potential adverse effect on glycemic control. In September 2000, the American Medical Association published results of an Arterial Disease Multiple Intervention Trial (ADMIT) sub-study, which concluded that lipid-modifying doses of niacin have a minimal impact on glucose levels and can be safely prescribed for patients with diabetes as an alternative when statins or fibrates are inadequate or not tolerated.

The ADMIT study found that use of Upsher-Smith's immediate-release Niacor ® helped reduce total cholesterol by 4%, LDL ("bad") cholesterol by 8% and triglycerides by 23%, while increasing HDL cholesterol levels by 29% -- with minimal impact on glycemic control. Niacin use resulted in a small but statistically significant increase in average glucose levels in participants with diabetes. The dropout rate for niacin therapy was similar for both diabetic and non-diabetic patients, with dropout rates of 23% and 16% respectively.

"Based on the ADMIT sub-study findings, doctors can now consider niacin for their diabetic patients suffering from high LDL cholesterol and triglycerides, as well as low HDL cholesterol levels," says Dritsas. "This is especially good news for patients who have not responded well to the more commonly prescribed statin drugs or fibrates."

The ADMIT sub-study findings were published in the September 13, 2000 issue of The Journal of the American Medical Association--Volume 284, No. 10. Currently, Niacor ® is the only prescription, immediate-release niacin tablets product on the market for the treatment of dyslipidemia.

Three-Year Landmark HATS Study Finds Niacin and Simvastatin a Powerful Combination in Treating Coronary Disease, Decreasing Cardiac Events as Much as 70%

The HDL Atherosclerosis Treatment Study (HATS) conducted by University of Washington researcher B. Greg Brown, M.D., Ph.D., indicates that using a combination of niacin and simvastatin in the treatment of coronary disease can reduce the risk of cardiovascular events such as death, heart attacks, strokes and bypass procedures by as much as 70%. Dr. Brown's findings, presented on November 13, 2000 at the American Heart Association's 73rd Scientific Sessions, also indicate that a niacin-simvastatin combination can be highly effective in reducing the progression of atherosclerosis -- the underlying cause of heart disease -- while antioxidant vitamins appear not to provide the same benefit.

Niacin has been long recognized as an effective treatment for increasing HDL ("good") cholesterol in patients with low HDL levels, while lipid-modifying statins are widely prescribed for lowering high LDL ("bad") cholesterol. Dr. Brown's study focused on patients with known heart disease who had low levels of HDL and normal levels of LDL. When treated with a combination of simvastatin and Upsher-Smith's NIACOR(R) or SLO-NIACIN(R) products, patients experienced a marked decrease in LDL cholesterol levels, complemented by a significant increase in HDL cholesterol. Patients also saw a virtual halt in the progression of arterial plaque build-up or atherosclerosis.

"Our study concludes that a combination of niacin and simvastatin provides better results for the treatment of heart disease than the results we would expect with simvastatin alone," says Dr. Brown. "People with heart disease, or those at high risk for heart disease, should benefit from this information, in particular the roughly 40% of heart disease patients who have low HDL."

"Dr. Brown's study demonstrates that niacin, used in combination with other lipid-modifying drugs, can have a significant impact in reducing the progression of atherosclerosis and reducing coronary events," says Upsher-Smith's Dritsas. "As the only pharmaceutical company promoting both immediate- and sustained-release niacin to the marketplace, our high-quality, affordable niacin tablets can enhance physicians' ability to treat heart disease."

Dr. Brown's research began in 1995 with 160 coronary heart disease patients. For more information, contact B. Greg Brown, M.D., Ph.D., University of Washington, Department of Medicine, Division of Cardiology. [Niacor ® 500 mg, immediate release] is available by prescription only. Over-the-counter Slo-Niacin® Tablets are available in 3 strengths: 250mg, 500mg, 750mg. Slo-Niacin ® uses a Polygel ® formulation that helps reduce nuisance side effects associated with niacin. The most common adverse effects of niacin products include flushing, pruritus and gastro-intestinal distress. Elevated liver function tests have been reported. Immediate-release and sustained-release niacin formulations are not interchangeable at equal doses. Physicians, pharmacists and patients should consult the Niacor ® and Slo-Niacin ® package inserts for additional information regarding the use of niacin.


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Editor: Susan K. Boyer, RN
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