title: Dyslipidemia in chronic kidney disease: randomized controlled trial of colestilan versus simvastatin in dialysis patients.
abstract: OBJECTIVE
  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.
authors: Division of Nephrology, University Hospital of Würzburg, Würzburg, Medical Clinic V (Nephrology, Hypertensiology, Endocrinology, Diabetology, Rheumatology) Mannheim Medical Faculty, University of Heidelberg, Synlab Academy, Mannheim, Germany, Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University Graz, Graz, Austria, Gomel Regional Specialized Clinical Hospital, Gomel, Brest Regional Hospital, Brest, Belarus, and Hospital A. Manzoni, Division of Nephrology and Dialysis, Lecco, Italy.
authors: Chistoph
authors: C
authors: Wanner
authors: Winfried
authors: W
authors: März
authors: Andrei
authors: A
authors: Varushchanka
authors: Natallia
authors: N
authors: Apanasovich
authors: Nickolay
authors: N
authors: Dosta
authors: Ruslan
authors: R
authors: Yakubtsevich
authors: Francesco
authors: F
authors: Locatelli
mesh_terms: D000328:Adult; D000368:Aged; D001647:Bile Acids and Salts / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D001647:Bile Acids and Salts; D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D008055:Lipids; D014280:Triglycerides; D019821:Simvastatin; C106574:cholebine