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.