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Wanner, C; März, W; Varushchanka, A; Apanasovich, N; Dosta, N; Yakubtsevich, R; Locatelli, F.
Dyslipidemia in chronic kidney disease: randomized controlled trial of colestilan versus simvastatin in dialysis patients.
Clin Nephrol. 2014; 82(3):163-172
Doi: 10.5414/CN108237
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
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März Winfried
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- Abstract:
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We evaluated the effects of colestilan, a non-absorbed anion-exchange resin, on lipids and lipoproteins in dialysis patients.
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.
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.
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.
- Find related publications in this database (using NLM MeSH Indexing)
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Adult -
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Aged -
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Bile Acids and Salts - adverse effects Bile Acids and Salts - therapeutic use
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Biological Markers - blood
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Cholesterol, HDL - blood
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Cholesterol, LDL - blood
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Double-Blind Method -
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Dyslipidemias - blood Dyslipidemias - complications Dyslipidemias - diagnosis Dyslipidemias - drug therapy
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Dyslipidemias -
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Female -
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Humans -
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Hypolipidemic Agents - adverse effects Hypolipidemic Agents - therapeutic use
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Lipids - blood
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Male -
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Middle Aged -
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Renal Dialysis -
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Renal Insufficiency, Chronic - blood Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - diagnosis Renal Insufficiency, Chronic - therapy
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Simvastatin - adverse effects Simvastatin - therapeutic use
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Time Factors -
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Treatment Outcome -
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Triglycerides - blood
- Find related publications in this database (Keywords)
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chronic kidney disease
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colestilan
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dialysis
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dyslipidemia
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MCI-196