Pharmacokinetics of the aldose reductase inhibitor tolrestat: Studies in healthy young and elderly male and female subjects and in subjects with diabetes

Clinical Pharmacology and Therapeutics

Volumn 59, Issue 6, 1996, Pages 603-612

  Fruncillo, Richard ^b   Troy, Steven ^b   Parker, Vernon ^b   Mayersohn, Michael ^b   Hicks, David ^b   Kraml, Michael ^b   Battle, Michele ^a   Chiang, Soong ^b  

^a WYETH AYERST RESEARCH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALDOSE REDUCTASE INHIBITOR; TOLRESTAT;

ADULT; AGE; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG CLEARANCE; DRUG DISPOSITION; DRUG EXCRETION; DRUG PROTEIN BINDING; FEMALE; GENDER; HUMAN; HUMAN EXPERIMENT; MALE; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PRIORITY JOURNAL;

ADMINISTRATION, ORAL; ADULT; AGED; AGING; ALDEHYDE REDUCTASE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DIABETES MELLITUS; ENZYME INHIBITORS; FEMALE; HALF-LIFE; HUMANS; INTESTINAL ABSORPTION; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NAPHTHALENES; SEX FACTORS;

EID: 0030017101     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-9236(96)90000-4     Document Type: Article

References (29)

1. Porte D, ed. Aldose reductase inhibition: an approach to the prevention of diabetic complications, New York: McGraw-Hill, 1987.
2. Humber LG. The medicinal chemistry of aldose reductase. In: Ellis GP, West GB, eds. Progress in medicinal chemistry; vol 24. Amsterdam: Elsevier, 1987:299-343.
3. Tomlinson DR, Willars GB, Carrington AL. Aldose reductase inhibitors and diabetic complications. Pharmacol Ther 1992;54:151-94.
4. Simard-Duquesne N, Greselin E, Dubuc J, Dvornik D. The effects of a new aldose reductase inhibitor (tolrestat) in galactosemic and diabetic rats. Metabolism 1985;34:885-92.
5. Robison WG Jr, Nogata M, Laver N, Hohman TC, Kinoshita JH. Diabetic-like retinopathy in rats prevented with an aldose reductase inhibitor. Invest Ophthalmol Vis Sci 1989;30:2285-92.
6. Simard-Duquesne N, Greselin E, Gonzalez R, Dvornik D. Prevention of cataract development in severely galactosemic rats by the aldose reductase inhibitor, tolrestat (42048). Proc Soc Exp Biol Med 1985;178:599-605.
7. McCaleb ML, McKean ML, Hohman TC, Laver N, Robison WG Jr. Intervention with the aldose reductase inhibitor, tolrestat, in renal and retinal lesions of streptozotocin-diabetic rats. Diabetologia 1991;34: 695-701.
8. Notvest RR, Inserra JJ. Tolrestat, an aldose reductase inhibitor, prevents nerve dysfunction in conscious diabetic rats. Diabetes 1987;36:500-4.
9. McCaleb ML, Sredy J, Millen J, Ackerman DM, Dvornik D. Prevention of urinary albumin excretion in 6 month streptozocin-diabetic rats with the aldose reductase inhibitor tolrestat. Diabet Complications 1988;2:16-8.
10. Boulton AJM, Levin S, Comstock J. A multicentre trial of the aldose-reductase inhibitor, tolrestat, in patients with symptomatic diabetic neuropathy. Diabetologia 1990;33:431-7.
11. Macleod AF, Boulton AJM, Owens DR, et al. A multicentre trial of the aldose-reductase inhibitor tolrestat, in patients with symptomatic diabetic peripheral neuropathy. Diabete Metab 1992;18:14-20.
12. Cayen MN, Hicks DR, Ferdinandi ES, Kraml M, Greselin E, Dvornik D. Metabolic disposition and pharmacokinetics of the aldose reductase inhibitor tolrestat in rats, dogs, and monkeys. Drug Metab Dispos 1985;13:412-9.
13. Dvornik D, Millen J, Hicks D, Cayen M, Sredy J. The pharmacokinetics of aldose reductase inhibitors. In: Sakamoto N, Kinoshita JH, Kador PF, Hotta N, eds. Polyol pathway and its role in diabetic complications. Amsterdam: Elsevier Science, 1988:61-71.
14. Hicks DR, Kraml M, Cayen MN, Dubuc J, Ryder S, Dvornik D. Tolrestat kinetics. Clin Pharmacol Ther 1984;36:493-9.
15. van Griensven JMT, Jusko WJ, Lemkes HPJ, et al. Tolrestat pharmacokinetic and pharmacodynamic effects on red blood cell sorbitol levels in normal volunteers and in insulin-dependent patients with diabetes. Clin Pharmacol Ther 1995;58:631-40.
16. Troy SM, Hicks DR, Kraml M, Conrad K, Chiang ST. The effect of renal disease on tolrestat pharmacokinetics. Clin Pharmacol Ther 1992;51:271-7.
17. Hicks DR, Kraml M. The determination of tolrestat in serum and tissues. Ther Drug Monit 1984;6:328-33.
18. Cayen MN, Kraml M, Ferdinandi ES, Greselin E, Dvornik D. The metabolic disposition of etodolac in rats, dogs, and man. Drug Metab Rev 1981;12: 339-62.
19. Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. New York: Marcel Dekker, 1982.
20. Metzler CM, Elfring GL, McEwan AJ. A package of computer programs for pharmacokinetic modeling. Biometrics 1974;30:562-3.
21. SAS Institute, Inc. SAST a user's guide: version 6, volume 1 and volume 2. 4th ed. Cary, North Carolina: SAS Institute, 1990.
22. Greenblatt DF, Divoll M, Harmatz JS, Shader RI. Oxazepam kinetics: effects of age and sex. J Pharmacol Exp Ther 1980;215:86-91.
23. Greenblatt DF, Divoll M, Abernethy DR, Moschitto LJ, Smith RB, Shader RI. Alprazolam kinetics in the elderly: relation to antipyrine disposition. Arch Gen Psychiatry 1983;40:287-90.
24. Mayersohn M. Special pharmacokinetic considerations in the elderly. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied pharmacokinetics. Vancouver, Washington: Applied Therapeutics, 1992:9-31-9-36.
25. Al-Turk WA, Stohs SJ, Roche EB. Altered activities of hepatic and extrahepatic microsomal mixed function oxidase enzymes in diabetic and adrenalectomized diabetic rats. Pharmacology 1981;23:337-45.
26. Past MR, Cook DE. Effect of diabetes on rat liver cytochrome P-450: evidence for a unique diabetes-dependent rat liver cytochrome P-450. Biochem Pharmacol 1982;31:3329-34.
27. Juan D, Molitch ME, Johnson MK, Carlson RF, Antal EJ. Unaltered drug metabolizing enzyme systems in type II diabetes mellitus before and during glyburide therapy. J Clin Pharmacol 1990;30:943-7.
28. Salmela PI, Sotaniemi EA, Pelkonen RO. The evaluation of the drug-metabolizing capacity in patients with diabetes mellitus. Diabetes 1980;29:788-94.
29. Daintith H, Stevenson IH, O'Malley K. Influence of diabetes mellitus on drug metabolism in man. Int J Clin Pharmacol Biopharm 1976;13:55-8.