CAS NO. 95522-45-5
英文别名 Colestilan chloride; Colestimide; Epichlorohydrin-2-methylimidazole copolymer
indRen (colestilan) has been launched for the treatment of hyperphosphataemia in patient with stage 5 chronic kidney disease who are currently receiving dialysis.
PHARMACOLOGY
Colestilan is an anion exchange resin. It binds to phosphate in the gut but is not absorbed from the gastrointestinal tract, thereby increasing phosphate excretion. As colestilan may affect the bioavailability or absorption of other medicinal products, these should be taken at least 1 hour before or 3 hours after colestilan.1
CLINICAL STUDIES
Investigators assessed colestilan in three key placebo-controlled, phase III studies: two open-label flexible-dose studies in which they adjusted the colestilan dose according to phosphate levels and one fixed-dose study in which they randomised patients to receive 3g, 6g, 9g, 12g or 15g of colestilan per day or placebo.1,2
Significant phosphate lowering
In all studies, colestilan at a dose of at least 6g daily resulted in a significantly reduced blood phosphate level after 12 weeks of treatment compared with placebo. An average dose of 11.5g and 13.1g daily in the first and second flexible-dose studies reduced the blood phosphate level by 0.36mmol and 0.50mmol per litre, respectively.1,2
In the fixed-dose study, significant changes in blood phosphate levels were observed for patients who received at least 6g of colestilan daily compared with placebo. These changes were dose dependent.1,2
GI upset
Most adverse events in trials were gastrointestinal in origin, including nausea, vomiting, dyspepsia, constipation and haemorrhage.1,2
