Back to Search
Start Over
Evaluation of colestilan in chronic kidney disease dialysis patients with hyperphosphataemia and dyslipidaemia: a randomized, placebo-controlled, multiple fixed-dose trial
- Source :
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 28(7)
- Publication Year :
- 2013
-
Abstract
- Background Colestilan is a non-absorbed, non-calcium-based, phosphate binder. It also binds bile acids and reduces serum levels of low-density lipoprotein cholesterol (LDL-C). This study evaluated the efficacy of a range of fixed doses of colestilan compared with placebo for the control of serum phosphorus and LDL-C levels in patients with CKD stage 5 on dialysis. Methods This was a multicentre, randomized, double-blind, placebo-controlled, multiple fixed-dose trial in which 642 patients with CKD stage 5 on dialysis who had both hyperphosphataemia and dyslipidaemia, were randomized to treatment with colestilan 3, 6, 9, 12 or 15 g/day or placebo for 12 weeks. The co-primary endpoints were the mean changes in serum phosphorus and the mean per cent change in LDL-C from baseline to Week 12. Results A significantly greater mean reduction in serum phosphorus level from baseline to Week 12 than seen with placebo was seen with 9 g (-0.28 mmol/L) and pooled colestilan 12/15 g (-0.34 mmol/L). The per cent reduction in LDL-C level was significantly greater with colestilan 3, 6 and 9 g and pooled colestilan 12/15 g than with placebo (reduction ranged from 15.9 to 27.6% dependent on dose). Colestilan also reduced total cholesterol, oxidized LDL-C, HbA1c and uric acid levels, and did not increase serum calcium levels. Colestilan was generally well tolerated; the most common adverse events affected the gastrointestinal system. Conclusions Colestilan is an effective treatment for hyperphosphataemia, and provides beneficial effects on other metabolic parameters associated with cardiovascular risk, notably LDL-C.
- Subjects :
- Male
medicine.medical_specialty
medicine.drug_class
medicine.medical_treatment
030232 urology & nephrology
030204 cardiovascular system & hematology
Placebo
Kidney Function Tests
Gastroenterology
Bile Acids and Salts
03 medical and health sciences
Hyperphosphatemia
chemistry.chemical_compound
0302 clinical medicine
Colestilan
Double-Blind Method
Renal Dialysis
Risk Factors
Internal medicine
medicine
Humans
Renal Insufficiency, Chronic
Dialysis
Dyslipidemias
Transplantation
Dose-Response Relationship, Drug
business.industry
Middle Aged
medicine.disease
Prognosis
3. Good health
Phosphate binder
Endocrinology
chemistry
Nephrology
Uric acid
Female
Hemodialysis
business
Kidney disease
Follow-Up Studies
Glomerular Filtration Rate
Subjects
Details
- ISSN :
- 14602385
- Volume :
- 28
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
- Accession number :
- edsair.doi.dedup.....71f5d776c15754c0255d4315e7a558cf