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

Kidney Int. 2002 Apr;61(4):1469-74. doi: 10.1046/j.1523-1755.2002.00262.x.

Abstract

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-methylglutaryl 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 > or =3.5 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 > or =3.5 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 < or =3.5 mmol/L compared with patients receiving placebo (85.4% vs. 16.0%; P < or = 0.001). The statistically significant difference between the two groups was maintained at week 8 and week 16 (P < or = 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Atorvastatin
  • Cholesterol, LDL / blood
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Heptanoic Acids / administration & dosage
  • Heptanoic Acids / adverse effects
  • Heptanoic Acids / therapeutic use*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hyperlipidemias / blood
  • Hyperlipidemias / therapy*
  • Male
  • Middle Aged
  • Peritoneal Dialysis, Continuous Ambulatory*
  • Placebos
  • Pyrroles / administration & dosage
  • Pyrroles / adverse effects
  • Pyrroles / therapeutic use*
  • Treatment Outcome

Substances

  • Cholesterol, LDL
  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Placebos
  • Pyrroles
  • Atorvastatin