We compared the effect of achieving an low-density lipoprotein cholesterol (LDL-cholesterol) <70 versus LDL-cholesterol <100 mg/dL with simvastatin or atorvastatin in diabetic patients.
This was an open-label, randomized, controlled trial. High-risk diabetic patients were randomly assigned to simvastatin or atorvastatin 10 mg. LDL-cholesterol was monitored at 30-day intervals. If LDL-cholesterol was >100 mg/dL, the doses of simvastatin and atorvastatin were increased to a maximum of 40 and 80 mg, respectively. Within each treatment group, patients were stratified by achieved LDL-cholesterol goals into 2 subgroups and followed thereafter up to 12 weeks.
Of the 140 subjects enrolled, 114 completed the study. Mean LDL-cholesterol levels after simvastatin therapy were 61 in the subgroup with LDL-cholesterol <70 mg/dL (n = 28) and 88 mg/dL in the subgroup with LDL-cholesterol <100 (n = 29). After atorvastatin therapy, mean LDL-cholesterol level was 56 in the subgroup with LDL-cholesterol <70 mg/dL (n = 30) compared with 89 mg/dL in the other subgroup (n = 27). After 12 weeks, there were no significant differences among groups or any significant within-group changes from baseline in cortisol, androstenedione, and total testosterone levels. A significant reduction in DHEA-S was observed in subjects with LDL-cholesterol <70 mg/dL in both simvastatin and atorvastatin groups at 12 weeks (P < 0.05 and P < 0.01, respectively). In conclusion achieving LDL-cholesterol levels between 55 and 70 mg/dL with simvastatin or atorvastatin has no considerable adverse impact on steroidogenesis in diabetic patients.