PLASMA-LIPOPROTEINS AND RENAL-FUNCTION DURING SIMVASTATIN TREATMENT IN DIABETIC NEPHROPATHY

The aim of this study was to assess the effect of simvastatin on plasma lipoproteins and renal function in hypercholesterolaemic Type 1 (insulin-dependent) diabetic patients with diabetic nephropathy. Twenty-six hypercholesterolaemic (total cholesterol greater-than-or-equal-to 5.5 mmol/l) Type 1 diabetic patients with nephropathy were enrolled in a double-blind randomized placebo-controlled study for 12 weeks. The active treatment group (n = 14) received simvastatin (1020 mg/day) for 12 weeks while the remaining 12 patients received treatment with placebo. The results during simvastatin treatment (baseline vs 12 weeks): total cholesterol 6.6 vs 4.8 mmol/l (p < 0.01), LDL-cholesterol 4.25 vs 2.57 mmol/l (p < 0.01) and apolipoprotein B 1.37 vs 1.06 mmol/l (p < 0.01). HDL-cholesterol, and apolipoprotein A-1 remained unchanged. Total cholesterol, LDL-cholesterol, HDL-cholesterol, apolipoprotein A-1, apolipoprotein B remained unchanged during placebo treatment. Albuminuria measured during the simvastatin and the placebo treatment (baseline vs 12 weeks) (the data are logarithmically transformed before analysis because of their positively skewed transformation; geometric mean(x/divided-by antilog SE) is indicated) was 458 (x/divided-by 1.58) vs 393 x/divided-by 1.61) and 481 (x/divided-by 1.62) vs 368 (x/divided-by 1.78-mu-/min (NS). Glomerular filtration rate during simvastatin and placebo treatment (baseline vs 12 weeks) was 64 vs 63 and 72 vs 74 ml . min-1.1.73 m-2, respectively. Two patients receiving simvastatin treatment were withdrawn, one due to gastrointestinal side effects and one due to myalgia. In conclusion, our short-term study in Type 1 diabetic patients with diabetic nephropathy did not reveal any beneficial effect on albuminuria despite a striking lipid-lowering effect of simvastatin in diabetic nephropathy