Efficacy, safety and tolerability of atorvastatin in dyslipidemic subjects with advanced (non-nephrotic) and endstage chronic renal failure

Abstract

Background: Patients with dyslipidemia and advanced renal failure are at markedly increased risk of cardiovascular morbidity and mortality. We evaluated the efficacy, safety, and tolerability of atorvastatin in non-nephrotic, dyslipidemic patients with chronic renal failure (CRF) or endstage renal failure (ESRF) receiving dialysis.

Methods: Following a 6-week baseline period, adult patients meeting Australian Heart Foundation treatment guidelines received atorvastatin for 16 weeks: 19 with CRF (predialysis), 17 on hemodialysis (HD), and 13 on continuous ambulatory peritoneal dialysis (CAPD). Dose (10-40 mg daily) was titrated to achieve lipid-lowering targets. Efficacy was determined by monitoring lipids (principally triglycerides and low-density lipoprotein [LDL] cholesterol); safety and tolerance by monitoring clinical and laboratory parameters.

Results: Atorvastatin was effective in reducing LDL cholesterol from baseline at each of weeks 4, 8, 12, and 16 in all study groups, with reductions of more than 40% at week 16. Sixty-two percent of PD, 73% of HD, and 100% of CRF patients were at or below target (<2.6 mmol/l) for LDL cholesterol at week 16. Significant reductions in triglycerides (approximately 27%) were seen in the CRF and combined HD/CAPD groups at all time points. Depending on the group, 65%-83% of patients were at or below target (<2.0 mmol/l) for triglycerides at week 16. The majority of patients received the 10-mg dose. Atorvastatin also reduced total cholesterol and apolipoprotein B levels in all groups and very-low-density lipoprotein (VLDL) cholesterol in the CRF group. Significant increases in LDL particle size were found in the HD and combined HD/CAPD groups. Minor, particularly gastrointestinal, symptoms were common. Three patients reported musculoskeletal symptoms, but creatine kinase was raised in only one.

Conclusion: Atorvastatin is an effective lipid-lowering agent for dyslipidemic subjects with advanced and endstage renal failure, and was reasonably well tolerated.