Simvastatin treatment of hypercholesterolemia in patients with insulin dependent diabetes mellitus.

The effects of 16 weeks therapy with the HMG-CoA reductase inhibitor Simvastatin 10-20 mg (n = 12) was compared to placebo (n = 13) in 25 euthyreoid males with insulin dependent diabetes mellitus and fasting total serum cholesterol above 6 mmol/l. Insulin dependence was defined as a glucagon stimulated C-peptide level less than 0.6 mmol/l. The study was placebo-controlled, double-blind with a parallel group design. Body weight, blood pressure, glycemic control as well as liver enzymes were unchanged and simvastatin was well tolerated by all patients. Ophthalmological slitlamp examination before and at the end of the study period did not show development of new lenticular opacities. Simvastatin decreased serum total cholesterol from 6.7 +/- 1.0 mmol/l (mean +/- SD) to 4.9 +/- 0.4 (p < 0.001 vs. placebo) and LDL-cholesterol from 4.6 +/- 0.7 mmol/l to 2.8 +/- 0.3 (p < 0.001 vs. placebo). HDL-cholesterol and triglycerides remained unaltered. A positive influence on the atherosclerotic process in patients with insulin dependent diabetes mellitus remains, however, to be proven.

RCT Entities:   Population Interventions Outcomes