The pharmacokinetics of pioglitazone in patients with impaired renal function

British Journal of Clinical Pharmacology

Volumn 55, Issue 4, 2003, Pages 368-374

  Budde, Klemens ^a   Neumayer, Hans Hellmut ^a   Fritsche, Lutz ^a   Sulowicz, Wladyslaw ^b   Stompôr, Tomasz ^b   Eckland, David ^c  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b JAGIELLONIAN UNIVERSITY   (Poland)

^c Takeda Europe R and D Centre   (United Kingdom)

Author keywords

Pharmacokinetics; Pioglitazone; Renal impairment; Type 2 diabetes

Indexed keywords

CREATININE; DRUG METABOLITE; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR AGONIST; PIOGLITAZONE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DISEASE SEVERITY; DOSE RESPONSE; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; EVALUATION; FEMALE; FOLLOW UP; HUMAN; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; KIDNEY INJURY; MALE; MULTIPLE DRUG DOSE; OPEN STUDY; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; FEMALE; HALF-LIFE; HUMANS; HYPOGLYCEMIC AGENTS; KIDNEY DISEASES; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; THIAZOLES; THIAZOLIDINEDIONES;

EID: 0038746657     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.2003.01785.x     Document Type: Article

References (23)

1. DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977-986.
2. UKPDS Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-853.
3. Akerblom H, Alberti KGMM, Baba S et al. Prevention of Diabetes Mellitus, Technical Report Series 1994. Geneva: World Health Organization, 2001: 1-100.
4. Rabkin R, Simon NM, Steiner S, Colwell JA. Effect of renal disease on renal uptake and excretion of insulin in man. N Engl J Med 1970; 282: 182-187.
5. Aronoff S, Rosenblatt S, Braithwaite S. Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. The Pioglitazone 001 Study Group. Diabetes Care 2000; 23: 1605-1611.
6. Gillies PS, Dunn CJ. Pioglitazone. Drugs 2000; 60: 333-343.
7. Scholz GH, Scherbaum WA, Lubben G. Pioglitazone - a review of preclinical data. Diabetes Stoffwechsel 2001; 9: 23-30.
8. Paul M. [Mechanisms and clinical effects of pioglitazone as a new agent for the treatment of type-2 diabetes.] Arzneimittelforschung 1999; 49: 835-842.
9. Fuchtenbusch M, Standl E, Schatz H. Clinical efficacy of new thiazolidinediones and glinides in the treatment of type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes 2000; 108: 151-163.
10. Yamasaki Y, Kawamori R, Wasada T et al. Pioglitazone (AD-4833) ameliorates insulin resistance in patients with NIDDM. AD-4833 Glucose Clamp Study Group, Japan. Tohoku J Exp Med 1997; 183: 173-183.
11. Eckland DA, Danhof M. Clinical pharmacokinetics of pioglitazone. Exp Clin Endocrinol 2001; 108: S234-S242.
12. Edwards G, Eckland DJA. Pharmacokinetics of pioglitazone in patients with renal impairment. Diabetologia 1999; 42 (Suppl. 1): A863.
13. Yamashita K, Murakami H, Okuda T, Motohashi M. High-performance liquid chromatographic determination of pioglitazone and its metabolites in human serum and urine. J Chromatogr B Biomed Appl 1996; 677: 141-146.
14. Harrower AD. Pharmacokinetics of oral antihyperglycaemic agents in patients with renal insufficiency. Clin Pharmacokinet 1996; 31: 111-119.
15. Tan MH. Current treatment of insulin resistance in type 2 diabetes mellitus. Int J Clin Pract 2000; 113 (Suppl.): 54-62.
16. Hanefeld M, Belcher G. Safety profile of pioglitazone. UCP 2001; 121 (Suppl.): 27-31.
17. Kiyota Y, Kondo T, Maeshiba Y et al. Studies on the metabolism of the new antidiabetic agent pioglitazone. Identification of metabolites in rats and dogs. Arzneimittelforschung 1997; 47: 22-28.
18. Rowland M, Tozer TN. Clinical Pharmacokinetics: Concepts and Applications, 3rd edn. Baltimore, MD: Lippincott, Williams & Wilkins, 1995: 1-601.
19. Touchette MA, Slaughter R.L. The effect of renal failure on hepatic drug clearance. DICP 1991; 25: 1214-1224.
20. Yuan R, Venitz J. Effect of chronic renal failure on the disposition of highly hepatically metabolized drugs. Int J Clin Pharmacol Ther 2000; 38: 245-253.
21. Burnier M, Aebischer P, Wauters JP, Schelling JL. Does renal failure induce a decrease in cyclosporine blood concentrations? Proc Eur Dial Transplant Assoc Eur Ren Assoc 1985; 21: 1002-1005.
22. Senekjian HO, Lee CS, Kuo TH, Au DS, Krothapalli R. Absorption and disposition of ibuprofen in hemodialyzed uremic patients. Eur J Rheumatol Inflamm 1983; 6: 155-162.
23. Zazgornik J, Huang ML, Van Peer A, Woestenborghs R, Heykants J, Stephen A. Pharmacokinetics of orally administered levocabastine in patients with renal insufficiency. J Clin Pharmacol 1993; 33: 1214-1218.