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

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.