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Simvastatin and Niacin Well Tolerated in Patients With or Without Diabetes

The combination of simvastatin and niacin appears to improve lipid profiles without inducing muscle or liver toxicities in patients with coronary artery disease (CAD) with or without diabetes mellitus.

Xue-Qiao Zhao, MD, Department of Medicine, Division of Cardiology, University of Washington School of Medicine, Seattle, United States, and colleagues recently reported data from the HDL-Atherosclerosis Treatment Study (HATS) indicating that 3 years of simvastatin plus niacin treatment in patients with CAD improved clinical and angiographic parameters, decreased levels of low-density lipoprotein cholesterol (LDL-C) and increased levels of high-density lipoprotein cholesterol (HDL-C).

In the current analysis, the researchers evaluated the safety and tolerability of this combination in a subgroup of HATS patients with or without diabetes. The researchers analysed 160 patients with CAD, including 25 with diabetes. Their baseline mean LDL-C level was 128 mg/dL; mean HDL-C was 31 mg/dL; mean triglyceride level was 217 mg/dL.

Patients were randomised to simvastatin plus niacin or placebo. They also received 4 factorial combinations of antioxidant vitamins or placebo. For 38 months, patients were examined for side effects, including gastrointestinal problems, nausea, anorexia, as well as vision, skin and energy problems, and muscle aches. In addition, levels of aspartame aminotransferase, creatine phosphokinase, uric acid, homocysteine and fasting glucose were monitored regularly.

Side effect frequencies were not significantly different between the patients who received simvastatin plus niacin (30%) and those on placebo (23%). Glycaemic control among diabetics decreased slightly in the simvastatin-niacin group but returned to pretreatment levels at 8 months and stayed the same until the end of the study.

Patients taking niacin and simvastatin repeatedly described the medications as "very easy" or "fairly easy" to take compared to 86% of the placebo subjects.

"Taking all the side effects into account, the combination of simvastatin and niacin was very well tolerated in this study," the researchers conclude. "These data suggest that the simvastatin and niacin combination is a practical approach for the treatment of [dyslipidaemia]," they add.


Am J Cardiol 2004;93:307-312. "Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study)"

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