Pharmacokinetics of alpha-lipoic acid in subjects with severe kidney damage and end-stage renal disease

Journal of Clinical Pharmacology

Volumn 45, Issue 3, 2005, Pages 313-328

  Teichert, Jens ^a   Tuemmers, Tina ^a   Achenbach, Harald ^a   Preiss, Christa ^a   Hermann, Robert ^b   Ruus, Peter ^c   Preiss, Rainer ^a  

^a UNIVERSITY OF LEIPZIG   (Germany)

^b ALTANA PHARMA AG   (Germany)

^c SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

Author keywords

Alpha lipoic acid; Diabetic neuropathy; End stage renal disease; Pharmacokinetics

Indexed keywords

THIOCTIC ACID;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DISEASE SEVERITY; DRUG BIOAVAILABILITY; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMODIALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KIDNEY FAILURE; MALE; SIDE EFFECT; URINARY EXCRETION;

ADULT; AGED; ANTIOXIDANTS; FEMALE; HUMANS; KIDNEY; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; RENAL DIALYSIS; THIOCTIC ACID;

EID: 16844375015     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270004270792     Document Type: Article

References (38)

1. Suzuki YJ, Tsuchiya M, Packer L. Thioctic acid and dihydrolipoic acid are novel antioxidants which interact with reactive oxygen species. Free Rad Res Commun. 1991;15:255-263.
2. Packer L, Witt E, Tritschler HJ. Alpha-lipoic acid as a biological antioxidant. Free Rad Biol Med. 1995;19:227-250.
3. Packer L, Tritschler HJ, Wessel K: Neuroprotection by the metabolic antioxidant α-lipoic acid. Free Rad Biol Med. 1997;22:359-378.
4. Biewenga GW, Haenen GRMM, Bast A. The pharmacology of the antioxidant lipoic acid. Gen Pharmacol. 1997;29:315-331.
5. Femiano F, Scully C, Gombos F. Idiopathic dysgeusia: an open trial of alpha lipoic acid (ALA) therapy. Int J Oral Maxillofac Surg. 2002;31:625-628.
6. Femiano F, Scully C. Burning mouth syndrome(BMS): double blind controlled study of alpha-lipoic acid (thioctic acid) therapy. J Oral Path Med. 2002;31:267-269.
7. Hager K, Marahrens A, Kenklies M, Riederer P, Munch G. Alpha-lipoic acid as a new treatment option for Alzheimer type dementia. Arch Gerontol Geriatr. 2001;32:275-282.
8. Cakatay U, Telci A, Kayali R, Sivas A, Akcay T. Effect of α-lipoic acid supplementation on oxidative protein damage in the streptotocin-diabetic rat. Res Exp Med. 2000;199:243-251.
9. Stevens MJ, Ohrosova I, Cao X, Van Huysen C, Greene DA. Effects of DL-a-lipoic acid on peripheral nerve conduction, blood flow, energy metabolism, and oxidative stress in experimental diabetic neuropathy. Diabetes. 2000;49:1006-1015.
10. Sharma M, Gupta YK: Effect of alpha lipoic acid on intracerebro- ventricular streptotocin model of cognitive impairment in rats. Eur Neuropsychopharmacol. 2003;13:241-247.
11. Melheim MF, Craven PA, Derubertis FR. Effects of dietary supplementation of alpha-lipoic acid on early glomerular injury in diabetes mellitus. J Am Soc Nephrol. 2001;12:124-133.
12. Melhem MF, Craven PA, Liachenko J, DeRubertis FR. Alpha-lipoic acid attenuates hyperglycemia and prevents glomerular mesangial matrix expansion in diabetes. J Am Soc Nephrol. 2002;13:108-116.
13. Obrosova IG, Fathallah L, Liu E, Nourooz-Zadeh J. Early oxidative stress in the diabetic kidney: Effect of DL-α-lipoic acid. Free Rad Biol Med. 2003;34:186-195.
14. Midaoui AE, Elimadi A, Wu L, Haddad PS, de Champlain J. Lipoic acid prevents hypertension, hyperglycemia, and the increase in heart mitochondrial superoxide production. Am J Hypertens. 2003;16:173-179.
15. Borcea V, Nourooz-Zadeh J, Wolff SP, et al. α-Lipoic acid decreases oxidative stress even in diabetic patients with poor glycemic control and albuminuria. Free Rad Biol Med. 1999;22:1495-1500.
16. Yokoyama H, Okudaira M, Otani T, et al. High incidence of diabetic nephropathy in early-onset Japanese NIDDIM patients. Diabetes Care. 1998;21:1080-1085.
17. UK Prospective Diabetes Study (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.
18. Greene DA, Stevens MJ, Obrosova I, Feldmann EL. Glucose-induced oxidative stress and programmed cell death in diabetic neuropathy. Eur J Pharmacol. 1999;375:217-223.
19. Boulton AJ. Guidelines for diagnosis and outpatient management of diabetic peripheral neuropathy. European Association for the Study of Diabetes. Neurodiab Diabetes Metab. 1998;24(suppl 3):55-65.
20. Reljanovic M, Reichel G, Rett K, et al. Treatment of diabetic polyneuropathy with the antioxidant thioctic acid (alpha-lipoic acid): a two year multicenter randomized double-blind placebo-controlled trial (ALADIN II). Alpha Lipoic Acid in Diabetic Neuropathy. Free Radical Res. 1999;31:171-179.
21. Ziegler D, Schatz H, Conrad F, Cries FA, Ulrich H, Reichel G. Effects of treatment with the antioxidant alpha-lipoic acid on cardiac autonomic neuropathy in NIDDIM patients: a 4-month randomized controlled multicenter trial (DEKAN Study). Deutsche Kardiale Autonome Neuropathie. Diabetes Care. 1997;20:369-373.
22. Ametov AS, Barinov A, Dyck PJ, et al. The sensory symptoms of diabetic polyneuropathy are improved with α-lipoic acid. The SYDNEY Trial. Diabetes Care. 2003;26:770-776.
23. Teichert J, Kern J, Tritschler HJ, Ulrich H, Preiss R. Investigations on the pharmacokinetics of α-lipoic acid in healthy volunteers. Int J Clin Pharmacol Ther. 1998;36:625-628.
24. Schupke H, Hempel R, Peter G, et al. New metabolic pathways of α-lipoic acid. Drug Metab Dispos. 2001;29:855-862.
25. Teichert J, Hermann R, Ruus P, Preiss R. Plasma kinetics, metabolism, and urinary excretion of alpha-lipoic acid following oral administration in healthy volunteers. J Clin Pharmacol. 2003;43:1257-1267.
26. Yuan R, Venitz J. Effect of chronical renal failure on the disposition of highly metabolized drugs. Int J Clin Pharmacol Ther. 2000;38:245-253.
27. Teichert J, Preiss R. High-performance liquid chromatographic assay for α-lipoic acid and five of its metabolites in human plasma and urine. J Chromatogr B. 2002;769:269-281.
28. SPSS, Inc. SigmaStat version 3.0. Chicago: SPSS; 2003.
29. Pharsight Corporation. WinNonlin Professional, Version 4.0. Cary, NC: SAS Institute; 2002.
30. Hermann R, Niebch G, Borbe HO, et al. Enantioselective pharmacokinetics and bioavailability of different racemic α-lipoic acid formulations in healthy volunteers. Eur J Pharm Sci. 1996;4:167-174.
31. Hermann R, Niebch G. Human pharmacokinetics of α-lipoic acid. In: Fuchs J, Packer L, Zimmer G, eds. Lipoic Acid in Health and Disease. New York: Marcel Dekker; 1997:337-359.
32. Shepkin V, Kawabata T, Packer L. NMR binding study of lipoic acid binding to bovine serum albumin. Biochem Mol Biol Int. 1994;33:879-886.
33. Korashy HM, Elbekai RH, El-Kadi AOS. Effects of renal diseases on the regulation and expression of renal and hepatic drug-metabolizing enzymes: a review. Xenobiotica. 2004;34:1-29.
34. Dreisbach AW, Lertora JJL. The effect of chronic renal failure on hepatic drug metabolism and drug disposition. Semin Dial. 2003;16:45-50.
35. Wanders RJA, van Grunsven EG, Jansen GA. Lipid metabolism in peroxisomes: enzymology, functions and dysfunctions of the fatty acid α- and β-oxidation systems in humans. Biochem Soc Trans. 2000;28:141-149.
36. Debeer LJ, Mannaerts GP. The mitochondrial and peroxisomal pathways of fatty acid oxidation in rat liver. Diabetes Metab. 1983;9:134-140.
37. Asayama K, Sandhir R, Sheikh FG, Hayashibe H, Nakane T, Sigh I. Increased peroxisomal fatty acid β-oxidation and enhanced expression of peroxisome proliferators-activated receptor-α in diabetic rat liver. Mol Cell Biochem. 1999;194:227-234.
38. Yechoor VK, Patti ME, Saccone R, Kahn CR. Coordinated patterns of gene expression for substrate and energy metabolism in skeletal muscle of diabetic mice. Proc Natl Acad Sci USA. 2002;99:10587-10592.