Aldose reductase inhibitors: The end of an era or the need for different trial designs?

Diabetes

Volumn 46, Issue SUPPL. 2, 1997, Pages

  Pfeifer, Michael A ^a   Schumer, Mary P ^a   Gelber, David A ^b  

^a EAST CAROLINA UNIVERSITY   (United States)

^b SOUTHERN ILLINOIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALDOSE REDUCTASE INHIBITOR;

AUTONOMIC NEUROPATHY; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES CONTROL; DIABETIC NEUROPATHY; DOUBLE BLIND PROCEDURE; DRUG SCREENING; FOOT ULCER; HUMAN; HYPERGLYCEMIA; INSULIN DEFICIENCY; MAJOR CLINICAL STUDY; POLYNEUROPATHY; PRIORITY JOURNAL; SINGLE BLIND PROCEDURE;

EID: 0030931810     PISSN: 00121797     EISSN: None     Source Type: Journal    
DOI: 10.2337/diab.46.2.s82     Document Type: Conference Paper

References (60)

1. Pfeifer MA, Schumer MP: Clinical trials of diabetic neuropathy: past, present, and future. Diabetes 44:1355-1361, 1995
2. The Diabetes Control and Complications Trial 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 329:977-986, 1993
3. Tilton R, Chang K, Hasan K, Smith SR, Petrash JM, Misko TP, Moore WM, Currie MG, Corbett JA, McDaniel ML, Williamson JR: Prevention of diabetic vascular dysfunction by guanidines: inhibition of nitric oxide synthase versus advanced glycation end-product formation. Diabetes 42:221-232, 1993
4. Greene DA, Lattimer SA, Sima AAF: Pathogenesis and prevention of diabetic neuropathy. Diabetes Metab Rev 4:201-221, 1988
5. Gregersen G, Borsting H, Theil P, Servo C: Myoinositol and function of peripheral nerves in human diabetics: a controlled clinical trial. Acta Neurol Scand 58:241-248, 1978
6. Handelsman DJ, Turtle JR: Clinical trial of an aldose reductase inhibitor in diabetic neuropathy. Diabetes 30:459-464, 1981
7. Culebras A, Alio J, Herrera J, Lopez-Fraile IP: Effect of an aldose reductase inhibitor on diabetic peripheral neuropathy. Arch Neurol 33:133-134, 1981
8. Fagius J, Jameson S: Effects of aldose reductase inhibitor treatment in diabetic polyneuropathy: a clinical and neurophysiological study. J Neurol Neurosurg Psychiatry 44:991-1001, 1981
9. Jaspan J, Herold K, Maselli R, Bartkus C: Treatment of severely painful diabetic neuropathy with an aldose reductase inhibitor relief of pain and improved somatic and autonomic nerve function. Lancet ii:758-763, 1983
10. Judzewitsch RG, Jaspan JB, Polonsky KS, Weinberg CR, Halter JB, Halar E, Pfeifer MA, Vukadinovic C, Bernstein L, Schneider M, Liang KY, Gabbay KH, Rubenstein AH, Porte D Jr: Aldose reductase inhibition improves nerve conduction velocity in diabetic patients. N Engl J Med 308:119-125, 1983
11. Young RJ, Ewing DJ, Clarke BF: A controlled trial of sorbinil, an aldose reductase inhibitor, in chronic painful diabetic neuropathy. Diabetes 32:938-942, 1983
12. Lewin IG, O'Brien IAD, Morgan MH, Corrall RJM: Clinical and neurophysiological studies with the aldose reductase inhibitor, sorbinil, in symptomatic diabetic neuropathy. Diabetologia 26:445-448, 1984
13. Jaspan JB, Herold K, Bartkus C: Effects of sorbinil therapy in diabetic patients with painful peripheral neuropathy and autonomic neuropathy. Am J Med 79 (Suppl. 5A):24-37, 1985
14. Fagius J, Brattberg A, Jameson S, Berne C: Limited benefit of treatment of diabetic polyneuropathy with an aldose reductase inhibitor a 24-week controlled trial. Diabetologia 28:323-329, 1985
15. Christensen JE, Vamek L, Gregersen G: The effect of an aldose reductase inhibitor (sorbinil) on diabetic neuropathy and neural function of the retina a double-blind study. Acta Neurol Scand 71:164-167, 1985
16. Jaspan JB, Towle VL, Maselli R, Herold K: Clinical studies with an aldose reductase inhibitor in the autonomie and somatic neuropathies of diabetes. Metabolism 35 (Suppl. 1):83-92, 1986
17. Lehtinen JM, Hyvonen SK, Uusitupa M, Puhakainen E, Halonen T, Kilpelainen H: The effect of sorbinil treatment on red cell sorbitol levels and clinical and electrophysiological parameters of diabetic neuropathy. J Neurol 233:174-177, 1986
18. Martyn CN, Reid W, Young RJ, Ewing DJ, Clarke BF: Six-month treatment with sorbinil in asymptomatic diabetic neuropathy. Diabetes 36:987-990, 1987
19. Sundkvist G, Lilia B, Rosen I, Agardh CD: Autonomic and peripheral nerve function in early diabetic neuropathy. Acta Med Scand 221:445-453, 1987
20. Guy RJC, Gilbey SG, Sheehy M, Asselman P, Watkins PJ: Diabetic neuropathy in the upper limb and the effects of twelve months' sorbinil treatment. Diabetologia 31:214-220, 1988
21. O'Hare JP, Morgan MH, Alden P, Chissel S, O'Brien IAD, Corrall RJM: Aldose reductase inhibition in diabetic neuropathy: clinical and neuropathophysiological studies of one year's treatment with sorbinil. Diabetic Med 5:537-542, 1988
22. Sima AA, Bril V, Nathaniel V, McEwen TA, Brown MB, Lattimer SA, Greene DA: Regeneration and repair of myelinated fibers in sural-nerve biopsy specimens from patients with diabetic neuropathy treated with sorbinil. N Engl J Med 319:548-555, 1988
23. Boulton AJM, Levin S, Comstock J: A multicentre trial of the aldose reductase inhibitor, tolrestat, in patients with symptomatic diabetic neuropathy. Diabetologia 33:431-437, 1990
24. Gieron MA, Malone JI, Lowitt S, Korthals JK: Improvement in peripheral nerve function after one year of sorbinil. Neuroreport 2:348-350, 1991
25. Sima AAF, Nathaniel V, Prashar A, Bril V, Greene DA: Endoneurial microvessels in human diabetic neuropathy: endothelial cell dysjunction and lack of treatment effect by aldose reductase inhibitor. Diabetes 40:1090-1099, 1991
26. Florkowski CM, Rowe BR, Nightingale S, Harvey TC, Barnett AH: Clinical and neurophysiological studies of aldose reductase inhibitor ponalrestat in chronic symptomatic diabetic peripheral neuropathy. Diabetes 40:129-133, 1991
27. Ziegler D, Mayer P, Rathmann W, Gries FA: One-year treatment with aldose reductase inhibitor, ponalrestat, in diabetic neuropathy. Diabetes Res Clin Pract 14:63-74, 1991
28. Macleod AF, Boulton AJM, Owens DR, Van Rooy P, Van Gerven JMA, Macrury S, Scarpello JHB, Segers O, Heller SR, Van Der Veen EA, the North European Tolrestat Study Group: A multicentre trial of the aldose reductase inhibitor tolrestat, in patients with symptomatic diabetic peripheral neuropathy. Diabete Metab 18:14-20, 1992
29. Van Gerven JMA, Lemkes HHPJ, Van Dijk JG: Long-term effects of tolrestat on symptomatic diabetic sensory polyneuropathy. J Diabetes Complications 6:45-48, 1992
30. Krentz AJ, Honigsberger L, Ellis SH, Hardman M, Nattrass M: A 12 month randomized controlled study of the aldose reductase inhibitor ponalrestat in patients with chronic symptomatic diabetic neuropathy. Diabetic Med 9:463-468, 1992
31. Sundkvist G, Armstrong FM, Bradbury JE, Chaplin C, Ellis SH, Owens DR, Rosen I, Sonksen P: Peripheral and autonomic nerve function in 259 diabetic patients with peripheral neuropathy treated with ponalrestat (an aldose reductase inhibitor) or placebo for 18 months. J Diabetes Complications 6:123-130,1992
32. Guigliano D, Marfella R, Quatraro A, DeRosa N, Salvatore T, Cozzolino D, Ceriello A, Torella R: Tolrestat for mild diabetic neuropathy. Ann Intern Med 118:7-11, 1993
33. Sima AAF, Prashar A, Nathaniel V, Bril V, Werb MR, Greene DA: Overt diabetic neuropathy: repair of axo-glial dysjunction and axonal atrophy by aldose reductase inhibition and its correlation to improvement in nerve conduction velocity. Diabetic Med 10:115-121, 1993
34. Sima AAF, Greene DA, Brown MB, Hohman TC, Hicks D, Graepel GJ, Bochenek WJ, Beg M, Gonen B: Effect of hyperglycemia and the aldose reductase inhibitor tolrestat on sural nerve biochemistry and morphometry in advanced diabetic peripheral polyneuropathy. J Diabetes Complications 7:157-169, 1993
35. Goto Y, Hotta N, Shigeta Y, Sakamoto N, Kito S, Matsuoka K, Takahashi A, Kikkawa R, Sakuma A: A placebo-controlled double-blind study of epalrestat (ono-2235) in patients with diabetic neuropathy. Diabetic Med 10:39S-43S, 1993
36. Sorbinil Retinopathy Trial Research Group: The Sorbinil Retinopathy Trial: neuropathy results. Neurology 43:1141-1149, 1993
37. Santiago JV, Sönksen PH, Boulton AJ, Macleod A, Beg M, Bochenek W, Graepel GJ, Gonen B, the Tolrestat Study Group: Withdrawal of the aldose reductase inhibitor tolrestat in patients with diabetic neuropathy: effect on nerve function. J Diabetes Complications 7:170-178, 1993
38. Roy TM, Broadstone VL, Peterson HR, Snider HL, Cyrus J, Fell R, Rothchild AH, Samols E, Pfeifer MA The effect of an aldose reductase inhibitor on cardiovascular performance in patients with diabetes mellitus. Diabetes Res Clin Pract 10:91-97, 1990
39. Green A, Jaspan J, Kavin H, Chung S, Schoenberg H: Influence of long-term aldose reductase inhibitor therapy on autonomic dysfunction of urinary bladder, stomach and cardiovascular systems in diabetic patients. Diabetes Res Clin Pract 4:67-75, 1987
40. Gill JS, Williams G, Ghatei MA, Hetreed AH, Mather HM, Bloom SR: Effect of the aldose reductase inhibitor, ponalrestat, on diabetic neuropathy. Diabete Metab 16:296-302, 199
41. Faes TJC, Yff GA, DeWeerdt O, Lanting P, Heimans JJ, Bertelsmann FW: Treatment of diabetic autonomie neuropathy with an aldose reductase inhibitor J Neurol 240:156-160, 1993
42. Boland OM, Blackwell CC, Clarke BF, Ewing DJ: Effects of ponalrestat, an aldose reductase inhibitor, on neutrophil killing of Escherichia coli and autonomie function in patients with diabetes mellitus. Diabetes 42:336-340, 1993
43. Pfeifer MA, Peterson H, Snider H, Cyrus J, Broadstone VL, Roy T, Samols E: Long-term open-label sorbinil therapy prevents the progression of diabetic neuropathy (Abstract). Diabetes 37 (Suppl. 1):45A, 1988
44. Ziegler D, Laux G, Dannehl K, Spuler M, Muhlen H, Mayer P, Gries FA: Assessment of cardiovascular autonomie function: age-related normal ranges and reproducibility of spectral analysis, vector analysis, and standard tests of heart rate variation and blood pressure responses. Diabetic Med 9:166-175, 1992
45. Pfeifer MA, Weinberg, CR, Cook D, Best JD, Reenan A, Halter JB: Differential changes of autonomie nervous system function with age in man. Am J Med 75:249-258, 1983
46. Greene DA, Sima AAF: Effects of aldose reductase inhibitors on the progression of nerve damage. Diabetic Med 10 (Suppl. 2):31S-32S, 1993
47. Pirart J: Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between 1947 and 1973, pt. 1. Diabetes Care 1:168-188, 1978
48. Pirart J: Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between 1947 and 1973, pt. 2. Diabetes Care 1:252-263, 1978
49. Gregerson G: Variations in motor conduction velocity produced by acute changes of the metabolic state in diabetic patients. Diabetologia 4:273-277, 1968
50. The Diabetes Control and Complications Research Group: The effect of intensive diabetes therapy on the development and progression of neuropathy. Ann Intern Med 122:561-568, 1995
51. Ewing DJ, Martyn CN, Young RJ, Clarke BF: The value of cardiovascular autonomic function tests: 10 years' experience in diabetes. Diabetes Care 8:491-498, 1985
52. Pfeifer MA, Weinberg CR, Cook D, Reenan A, Halter JB, Ensinck J, Porte D Jr Autonomic neural dysfunction in recently diagnosed diabetic subjects. Diabetes Care 7:447-153, 1984
53. Lehtinen JM, Uusitupa M, Siitonen O, Pyörälä K: Prevalence of neuropathy in newly diagnosed NIDDM and nondiabetic control subjects. Diabetes 38:1307-1313, 1989
54. Ratzmann KP, Raschke M, Gander I, Schimke E: Prevalence of peripheral and autonomic neuropathy in newly diagnosed type II (noninsulin-dependent) diabetes. J Diabetes Complications 5:1-5, 1991
55. 54a. Laudadio C, Sima AAF: Progression rates of diabetic neuropathy in placebo patients in an 18 month clinical trial. J Diab Comp. In press
56. Dyck PJ, Kratz KM, Lehman KA, Karnes JL, Melton LJ III, O'Brien PC, Litchy WJ, Windebank AJ, Smith BE, Low PA, Service FJ, Rizza RA, Zimmerman BR: The Rochester Diabetic Neuropathy Study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology 41:799-807, 1991
57. Ma DM, Liveson JA: Nerve Conduction Handbook. Philadelphia, F.A. Davis Co., 1983
58. Gelber D, Pfeifer MA, Schumer M, the Statil Study Group: Reliability and comparison of methods to calculate heart rate variability (Abstract). Diabetes 44 (Suppl. 1):66A, 1995
59. Gelber DA, Pfeifer MA, Broadstone VL, Munster EW, Peterson M, Arezzo JC, Shamoon H, Zeidler A, Clements R, Greene DA, Porte D Jr, Laudadio C, Bril V: Components of variance for vibratory and thermal threshold testing in normal and diabetic subjects. J Diabetes Complications 9:170-176, 1995
60. Dyck PJ, O'Brien PC: Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy. Diabetes Care 12:649-652, 1989