Efficacy and safety of tolrestat in the treatment of patients with peripheral sensorimotor diabetic neuropathy: An open-label, uncontrolled, pilot study

Current Therapeutic Research - Clinical and Experimental

Volumn 57, Issue 3, 1996, Pages 215-229

  Lopez, Rogelio Espinoza ^a,c   Suarez, Jorge ^a   Padron, Marco Antonio Cruz ^a   Torres, Jesus Diaz ^a   Martinez, Rene ^b  

^a PEMEX   (Mexico)

^b Wyeth Mexico   (Mexico)

^c NONE   (Mexico)

Author keywords

[No Author keywords available]

Indexed keywords

TOLRESTAT;

ADULT; ALOPECIA; ANESTHESIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DIABETIC NEUROPATHY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; ELECTROPHYSIOLOGY; FEMALE; HEADACHE; HEARTBURN; HUMAN; HYPERESTHESIA; IMPOTENCE; MALE; ORAL DRUG ADMINISTRATION; PAIN; PARESTHESIA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; SENSORIMOTOR NEUROPATHY; URINE INCONTINENCE;

EID: 9244258536     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0011-393X(96)80127-5     Document Type: Article

References (24)

1. Ziegler I, Cicnir P, Mayer K, et al. The natural course of peripheral and autonomic neural function during the first two years after diagnosis of type I diabetes. Klin Wochenschr. 1988;66:1085-1092.
2. Watkins PJ, Edmonds ME. Sympathetic nerve failure in diabetes. Diabetologia. 1983;25:73-77.
3. Brown MJ, Asbury AK. Diabetic neuropathy. Ann Neurol. 1984;115:2.
4. Cumins KL, Dorfman LJ. Nerve fiber conduction velocity and distribution: Studies of normal and diabetic human nerves. Ann Neurol. 1981;6:67.
5. Unger RH, Foster D. Diabetes mellitus. In: Wilson JD, Foster D, eds. Williams Textbook of Endocrinology. Philadelphia: WB Saunders; 1992:1301-1304.
6. Gillon KR, Hawthorne JN. Sorbitol, inositol, and nerve conduction in diabetes. Life Sci. 1983;32:1943.
7. Greene DA, Lattimer SA, Sima AAF. Sorbitol, phosphoinositides and sodium-potassium ATPase in the pathogenesis of diabetic complications. NEJM. 1987;316:599-606.
8. Judezewitch RG, Jaspan JB, Polonsky KS, et al. Aldose reductase inhibition improves nerve conduction velocity in diabetic patients. NEJM. 1983;308:119-125.
9. Dvornik D. Aldose reductase inhibition: An approach to prevention of diabetic complications. Presented at the Mid-Year Educational Conference of the American College of Neuropsychiatrists, March 19, 1988, Philadelphia, Pennsylvania.
10. Sestanj K, Bellini F, Fung S, et al. N-[[5-(trifluoromethyl)-6-methoxy-1-naphtalenyl] thioxomethyl]-N-methylglycine (tolrestat), a potent, orally active aldose reductase inhibitor. Presented at the Mid-Year Educational Conference of the American College of Neuropsychiatrists, March 19, 1988, Philadelphia, Pennsylvania.
11. Raskin P, Rosenstock J, Challis P, et al. Effect of tolrestat on red blood cell sorbitol levels in patients with diabetes. Clin Pharmacol Ther. 1985;38:625-630.
12. The Tolrestat in Painful Neuropathy Study Group. Objective (nerve conduction) and subjective (painful symptom) improvement in diabetic neuropathy following administration of tolrestat, a new aldose reductase inhibitor. Diabetologia. 1986;29:588A.
13. Harati Y, Niakan E, Logan C. Aldose reductase inhibitor (tolrestat) therapy in patients with diabetic peripheral neuropathy. Presented at the Diabetic Complications International Symposium, October 29-31, 1987; Rome, Italy.
14. Boulton AJM, Levin S, Comstock J. A multicentre trial of the aldose reductase inhibitor, tolrestat, in patients with symptomatic diabetic neuropathy. Diabetologia. 1990;33:431-437.
15. Ryder S, Sarokhan B, Shand DG, Mullane JF. Human safety profile of tolrestat: An aldose reductase inhibitor. Drug Dev Res. 1987;11:131-143.
16. Greene DA, Bocherek W, Harati Y, et al. Biochemical and morphometric response to tolrestat in human diabetic nerve. Presented at the European Association for the Study of Diabetes (EASD); September 1990; Copenhagen, Denmark.
17. Pirart J. Diabetes mellitus and its degenerative complications: A prospective study of 4,400 patients observed between 1947 and 1973. Diabetes Care. 1978;1:168-188.
18. Greene DA, Sima AAF, Stevens MJ, et al. Complications: Neuropathy, pathogenic considerations. Diabetes Care. 1992;15:1902-1925.
19. Weintraub M, Standish R. Tolrestat: An aldose reductase inhibitor for diabetic peripheral neuropathy. Hosp Formul. 1986;21:912-916.
20. Steinmetz PR, Balko C. The sorbitol pathway and the complications of diabetes. NEJM. 1973;288:831-836.
21. Boulton A. What causes neuropathic pain? J Diabetic Complications. 1992;6:34-39.
22. Britland ST, Young RJ, Sharma AK, Clarke BF. Association of painful and painless diabetes polyneuropathy with different patterns of nerve fiber degeneration and regeneration. Diabetes. 1990;39:898-908.
23. Koglin K, Clark C, Ryder S, Mullane JF. Results of the long term open-label administration of Alredase in the treatment of diabetic neuropathy. Diabetes. 1985;34(Suppl 1):202A. Abstract.
24. Gonen B. Tolrestat: Pharmacokinetics and safety trials. Int Proc J. 1991;4:2-8.