A placebo-controlled trial examining atorvastatin in dyslipidemic patients undergoing CAPD

Background. Individuals with chronic renal disease are at high risk of cardiovascular morbidity and mortality, and therefore the management of dyslipidemia is particularly important in this patient population. This double-blind randomized study investigated the efficacy and safety of the 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor, atorvastatin, in continuous ambulatory peritoneal dialysis (CAPD) patients with dyslipidemia. Methods. Following a two- to four-week baseline period, patients with low-density lipoprotein (LDL)-cholesterol greater than or equal to3.5 mmol/L (135 mg/dL) were randomized to receive either atorvastatin 10 mg (N = 82) or placebo (N = 95) for 16 weeks. If LDL-cholesterol remained greater than or equal to3.5 mmol/L, the dose of atorvastatin was titrated to 20 mg and 40 mg after four and eight weeks, respectively. Results. After four weeks a significantly greater proportion of patients receiving atorvastatin 10 mg had achieved the LDL-cholesterol goal less than or equal to3.5 mmol/L compared with patients receiving placebo (85.4% vs. 16.0%; P less than or equal to 0.001). The statistically significant difference between the two groups was maintained at week 8 and week 16 (P less than or equal to 0.001 at both time points). At week 16, patients receiving atorvastatin had significantly greater reductions from baseline in LDL-cholesterol, total cholesterol, triglycerides and total cholesterol:HDL-cholesterol ratio (all P = 0.0001), and a significantly greater increase from baseline in HDL-cholesterol (P = 0.001) than patients receiving placebo. The overall adverse event profile for atorvastatin was similar to that observed with placebo. Conclusions. Atorvastatin was effective in achieving target LDL-cholesterol levels in a high proportion of the dyslipidemic CAPD patients studied at doses that are well tolerated.