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

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.

• Authors: Chistoph Wanner, Winfried März, Andrei Varushchanka, Natallia Apanasovich, Nickolay Dosta, Ruslan Yakubtsevich, Francesco Locatelli
• Journal: Clinical nephrology (Clin Nephrol) Vol. 82 Issue 3 Pg. 163-72 (Sep 2014) ISSN: 0301-0430 [Print] Germany
• PMID: 25079861 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

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

Topics

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