Cholesterol lowering effects of simvastatin in patients with non-insulin dependent diabetes mellitus

The efficacy of the HMG CoA reductase inhibitor, simvastatin, was evaluated in 17 non-insulin dependent diabetic patients with total cholesterol levels greater than 6.7 mM. Following a mean interval of 8 weeks on a lipid lower diet, patients were randomized in a double blind manner to receive 20 mg simvastatin or placebo daily. The dose was doubled if LDL-cholesterol was greater than 3.62 mM at 6 weeks. After 12 weeks of treatment, simvastatin reduced total cholesterol by 30% (p < 0.001), LDL-cholesterol by 41% (p < 0.001) and apoprotein B levels by 28% (p < 0.001). There were no significant differences in response to placebo or simvastatin with respect to triglycerides, VLDL and HDL cholesterol, apoproteins AI and AII. Simvastatin significantly reduced the total/HDL cholesterol ratio (39%, p < 0.001) and the apoprotein B/AI ratio (33%, p < 0.001) at week 12. After week 12, all patients were treated with simvastatin and there was a sustained reduction in total cholesterol of approximately 30% after 52 weeks of therapy. The cholesterol lowering effect of simvastatin was at least as great in hypertriglyceridaemic as in normotriglyceridaemic patients. In simvastatin treated patients, fasting plasma glucose and HbA(lc) were marginally elevated after 12 and 52 weeks respectively. There were no significant clinical or biochemical side effects with simvastatin therapy. Simvastatin appears to be a safe and effective drug for the treatment of hypercholesterolaemia in non-insulin dependent diabetic patients.