title: Pharmacokinetics of rosiglitazone in patients with end-stage renal disease.
abstract: The pharmacokinetics and tolerability of a single 8-mg oral dose of rosiglitazone, an anti-diabetic agent, were compared in 10 long-term haemodialysis patients and 10 healthy volunteers. Haemodialysis patients received rosiglitazone 4 h after haemodialysis (non-dialysis day) and 3 h before haemodialysis (dialysis day). Haemodialysis did not influence rosiglitazone pharmacokinetics, and dialytic clearance was low (0.10 1/h). The mean area under the concentration-time curve (AUC(0-infinity)), the maximum observed plasma concentration (Cmax) and the half-life for rosiglitazone were similar in haemodialysis patients (non-dialysis day) and healthy individuals (2192 +/- 598 ng.h/ml versus 2388 +/- 494 ng.h/ml, 338 +/- 114 ng/ml versus 373 +/- 95 ng/ml, and 3.70 +/- 0.75 h versus 3.81 +/- 0.86 h, respectively). AUC(0-infinity) and Cmax were not markedly influenced by haemodialysis. Rosiglitazone dose adjustments are not warranted in patients with type 2 diabetes with end-stage renal failure on haemodialysis.
authors.affiliation: Clinical Pharmacology Unit, GlaxoSmithKline, Presbyterian Hospital, Philadelphia, PA, USA. kathleen_a_thompson-culkin@sbphrd.com
authors.forename: K
authors.initials: K
authors.lastname: Thompson-Culkin
authors.forename: B
authors.initials: B
authors.lastname: Zussman
authors.forename: A K
authors.initials: AK
authors.lastname: Miller
authors.forename: M I
authors.initials: MI
authors.lastname: Freed
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D000077154:Rosiglitazone; D013844:Thiazoles / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D045162:Thiazolidinediones
chemical_list: D007004:Hypoglycemic Agents; D013844:Thiazoles; D045162:Thiazolidinediones; D000077154:Rosiglitazone