Dyslipidemia in chronic kidney disease: randomized controlled trial of colestilan versus simvastatin in dialysis patients

Clin Nephrol. 2014 Sep;82(3):163-72. doi: 10.5414/cn108237.

Abstract

Aim: We evaluated the effects of colestilan, a non-absorbed anion-exchange resin, on lipids and lipoproteins in dialysis patients.

Methods: This randomized, double-blind, double-dummy, flexible-dose study incorporating a placebo-controlled withdrawal period tested for superiority vs. placebo and non-inferiority vs. simvastatin. Dialysis patients with serum low-density lipoprotein (LDL-C) ≥ 100 mg/dL received colestilan 3 - 12 g/day or simvastatin 10 - 40 mg/day for 16 weeks, and were then re-randomized to continue active medication or receive placebo for 4 weeks. Co-primary endpoints were the percent change in serum LDL-C level during the active and placebo comparison phases.

Results: Colestilan was non-inferior to simvastatin for lowering serum LDL-C (mean changes -29.5% vs. -28.9%; difference 0.6%, 95% CI -5.7, 4.5). Colestilan was more effective than placebo at maintaining control of serum LDL-C levels during the withdrawal phase (mean change +4.4% vs. +41.7%; difference -37.4%; p < 0.001). Reductions in total cholesterol were similar with both drugs, but simvastatin was more effective at controlling triglyceride levels. Adverse events most commonly affected the gastrointestinal system.

Conclusions: In dialysis patients, colestilan was more effective than placebo at maintaining control of serum LDL-C levels, was noninferior to simvastatin in terms of the reduction in LDL-C achieved, and was generally well tolerated.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Bile Acids and Salts / adverse effects
  • Bile Acids and Salts / therapeutic use*
  • Biomarkers / blood
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Double-Blind Method
  • Dyslipidemias / blood
  • Dyslipidemias / complications
  • Dyslipidemias / diagnosis
  • Dyslipidemias / drug therapy*
  • Europe
  • Female
  • Humans
  • Hypolipidemic Agents / adverse effects
  • Hypolipidemic Agents / therapeutic use*
  • Lipids / blood*
  • Male
  • Middle Aged
  • Renal Dialysis*
  • Renal Insufficiency, Chronic / blood
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / diagnosis
  • Renal Insufficiency, Chronic / therapy*
  • Simvastatin / adverse effects
  • Simvastatin / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Triglycerides / blood

Substances

  • Bile Acids and Salts
  • Biomarkers
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Hypolipidemic Agents
  • Lipids
  • Triglycerides
  • Simvastatin
  • cholebine

Associated data

  • EudraCT/2007-003364-21