Treatment of diabetic polyneuropathy with the antioxidant thioctic acid (α-lipoic acid): A two year multicenter randomized double-blind placebo-controlled trial (ALADIN II)

References

• 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. New England Journal of Medicine 1993; 329: 977–986
   PubMed Web of Science ®Google Scholar
• UK-Prospective Diabetes Study (UKPDS)-group. Intensive blood-glucose control with sulfonylureas or insulin compared to conventional treatment and risk of complications in patients with type II diabetes. (UKPDS 33). Lancet 1998; 352: 837–853
   PubMedGoogle Scholar
• Ziegler D., Hanefeld M., Ruhnau K.J., Meißner H.P., Lobisch M., Schütte K., Gries F.A., The ALADIN Study Group. Treatment of symptomatic diabetic peripheral neuropathy with the antioxidant α-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia 1995; 38: 1425–1433
   PubMed Web of Science ®Google Scholar
• Ziegler D., Mayer P., Mühlen H., Gries F.A. Effekte einer Therapie mit α-Liponsäure gegenüber Vitamin B1 bei der diabetischen Neuropathie. Diabetes und Stoftwechsel 1993; 2: 443–448
   Google Scholar
• Kihara M., Schmelzer J.D., Poduslo J.F. Aminoguanidine effects on nerve blood flow, vascular permeability, electrophysiology, and oxygen free radicals. Proceedings of the National Academy of Sciences 1991; 88: 6107–6111
   PubMed Web of Science ®Google Scholar
• Masson E.A., Boulton A.J.M. Aldose reductase inhibitors in the treatment of DNP. A review of the rationale and clinical evidence. Drugs 1990; 39: 190–202
   PubMed Web of Science ®Google Scholar
• Giugliano D., Marfella R., Quatraro A., DeRosa N., Salvatore T., Cozzolino D., Ceriello A., Torella R. Tolrestat for mild diabetic neuropathy: A 52 week, randomized, placebo-controlled trial. Annals of Internal Medicine 1993; 118: 7–11
   PubMedGoogle Scholar
• Thomas P.K. Growth factors and diabetic neuropathy. Diabetic Medicine 1994; 11: 732–739
   PubMedGoogle Scholar
• Hellweg R., Hartung H.D. Endogenous levels of nerve growth factor (NGF) are altered in experimental diabetes mellitus: a possible role for NGF in the pathogenesis of diabetic neuropathy. Journal of Neuroscience Research 1990; 26: 258–267
   PubMed Web of Science ®Google Scholar
• Cameron N.E., Cotter M.A. The relationship of vascular changes to metabolic factors in diabetes mellitus and their role in the development of peripheral nerve complications. Diabetes Metabolism Reviews 1994; 10: 189–224
   PubMed Web of Science ®Google Scholar
• Jamal G.A. The use of gamma linolenic acid in the prevention and treatment of diabetic neuropathy. Diabetic Medicine 1994; 11: 145–149
   PubMed Web of Science ®Google Scholar
• Quatraro A., Roca P., Donella C., Acampora R., Marfella R., Giugliano D. Acetyl-L-Carnetine for symptomatic diabetic neuropathy. Diabetologia 1995; 38: 123–123
   PubMedGoogle Scholar
• Low P., Nickander K.K. Oxygen free radicals effects in sciatic nerve in experimental diabetes. Diabetes 1991; 40: 873–877
   PubMed Web of Science ®Google Scholar
• Nickander K.K., Schmelzer J.D., Rohwer D.A., Low P.A. Effects of α-tocopherol deficiency on indices of oxidative stress in normal and diabetic peripheral nerve. Journal of Neurological Sciences 1994; 126: 6–14
   PubMed Web of Science ®Google Scholar
• Cameron N.E., Cotter M.A., Archibald V., Dines K.C., Maxfield E.K. Antioxidant and pro-oxidant effects on nerve conduction velocity, endoneuronal blood flow and oxygen tension in non-diabetic and streptozotocin diabetic rats. Diabetologia 1994; 37: 449–459
   PubMed Web of Science ®Google Scholar
• Scott B.C., Aruoma O.I., Evans P.J., O'Neill C., van der Vliet A., Cross C.E., Tritschler H., Halliwell B. Lipoic and dihydrolipoic acid as antioxidants. A critical evaluation. Free Radical Research Communications 1994; 20: 119–133
   Google Scholar
• Packer L., Witt E.H., Tritschler H.J. Alpha-lipoic acid: The metabolic antioxidant. Free Radicals in Biology and Medicine 1996; 20: 625–626
   PubMed Web of Science ®Google Scholar
• Han D., Handelman G., Marcocci L., Sen C.K., Roy S., Kobuchi H., Tritschler H.J., Flohé L., Packer L. Journal of Biological Factors 1997 Lipoic acid increases de novo, synthesis of cellular glutathione by improving cystine utilization; 9: 1–18
   Google Scholar
• Nickander K.K., McPhee B.R., Low P.A., Tritschler H.J. Alpha-lipoic acid: Antioxidant potency against lipid peroxidation of neural tissues in vitro, and implications for DNP. Free Radicals in Biology and Medicine 1996; 21: 631–639
   PubMed Web of Science ®Google Scholar
• Nagamatsu M., Nickander K.K., Schmelzer J.D., Raya A., Wittrock A., Tritschler H., Low P.A. Lipoic acid improves nerve blood flow, reduces oxidative stress, and improves distal nerve conduction in experimental diabetic neuropathy. Diabetes Care 1995; 18: 1160–1166
   PubMed Web of Science ®Google Scholar
• van Dam P.S., van Asbeck B.S., Bravenboer A., van Oirschot J.F.L.M., Gispen W.H., Marx J.J.M. Effects of α-lipoic acid and glutathione on systemic and aciatic nerve antioxidant levels in expertimental diabetes. Elsevier Science B. V. 1995; 223–228
   Google Scholar
• Murase K., Hattori A., Kohno M., Hayashi K. Stimulation of nerve growth factor synthesis secretion in mouse astroglial cells by coenzymes. Biochemistry and Molecular Biology International 1993; 30: 615–621
   PubMedGoogle Scholar
• Garrett N.E., Malcangio M., Dewhurst M., Tomlinson D.R. α-Lipoic acid corrects neuropeptide deficits in diabetic rats via induction of trophic support. Neuroscience Letters 1997; 222: 191–194
   PubMedGoogle Scholar
• Dimpfel W., Spüler M., Piernau F.K., Ulrich H. TA induces dose-dependent sprouting of neurites in cultured rat neuroblastoma cells. Developments in Pharmacology and Therapy 1990; 14: 193–199
   PubMedGoogle Scholar
• Ziegler D., Schatz H., Conrad F., Gries F.A., Ulrich H., Reichel G., The DEKAN Study Group. Effects of treatment with the antioxidant α-lipoic acid on cardiac autonomic neuropathy in NIDDM patients. A 4-month randomized controlled multicenter Trial (DEKAN-Study). Diabetes Care 1993; 20: 369–373
   Google Scholar
• Storr M., Bluthardt M. Atlas der klinischen Elektrophysiologie und Neurographie. W. Kahlhammer 1993
   Google Scholar
• Young M.J., Boulton A.J.M., Maclead A.F., Williams D.D.R., Sonksen P.H. A multicenter study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. Diabetologica 1993; 36: 150–154
   PubMed Web of Science ®Google Scholar
• Dyck P.J., O'Brien P.C. Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic polyneuropathy. Diabetes Care 1989; 12: 649–652
   PubMedGoogle Scholar
• The Peripheral Nerve Society. Diabetic polyneuropathy in controlled clinical trials: consensus report of the peripheral nerve society. Annals of Neurology 1995; 38: 478–482
   PubMedGoogle Scholar
• Baynes J.W. Role of oxidative stress in development of complications in diabetes. Diabetes 1991; 40: 405–412
   PubMed Web of Science ®Google Scholar
• Cameron N.E., Cotter M.A. Metabolic and vascular factors in the pathogenesis of diabetic neuropathy. Diabetes 1997; 46(2)31–37
   Google Scholar
• Low P.A., Nickander K.K., Tritschler H.J. The roles of oxidative stress and antioxidant treatment in experimental diabetic neuropathy. Diabetes 1997; 46(2)38–42
   Google Scholar
• Kihara M., Low P.A. Impaired vasoreactivity to nitric oxide in experimental diabetic neuropathy. Experimental Neurology 1995; 132: 180–185
   PubMedGoogle Scholar
• Strödter D., Lehmann E., Lehmann U., Tritschle H.J., Bretzel R.G., Federlin K. The influence of TA on metabolism and function of the diabetic heart. Diabetes Research and Clinical Practice 1995; 29: 19–26
   PubMed Web of Science ®Google Scholar
• Low P.A., Yao J.K., Kishi Y., Tritschler H.J., Schmelzer J.D., Zollmann P.J., Nickander K.K. Peripheral nerve energy metabolism in experimental diabetes. Neuroscience Research Communications 1997; 21: 49–56
   Google Scholar
• Cotter M.A., Keegan A., Cameron N.E. Defective corpus cavernosum function in diabetic rats: effects of antioxidants. Diabetologia 1998; 41(1)A51–A51
   PubMedGoogle Scholar
• Jack A., Cotter M.A., Cameron N.E. Antioxidant treatment effects on defective endothelium-derived hyperpolarizing factor and relaxation in the mesenteric vasculature of diabetic rats. Diabetes 1998; 47(1)A54–A54
   Google Scholar
• Obrosova I., Cao X., Greene D.A., Stevens M.J. Diabetes-induced changes in lens antioxidant status, glucose utilization and energy metabolism: effect of DL-α-lipoic acid. Diabetologia 1998; 41: 1442–1450
   PubMedGoogle Scholar
• Greene D.A., Cao X., van Huysen C., Obrosova I.G. Effects of DL-α-lipoic acid (LA) on diabetic nerve function, bioenergetics, and antioxidative defense. Diabetes 1998; 47(1)A136–A136
   Google Scholar
• Cameron N.E., Cotter M.A., Horrobin D.H., Tritschler H.J. Effects of α-lipoic acid on neurovascular function in diabetic rats: interaction with essential fatty acids. Diabetologia 1998; 41: 390–399
   PubMed Web of Science ®Google Scholar
• Hounsom L., Horrobin D.F., Tritschler H., Corder R., Tomlinson D.R. A lipoic acid-gamma linolenic acid conjugate is effective against multiple indices of experimental diabetic neuropathy. Diabetologia 1998; 41: 839–843
   PubMed Web of Science ®Google Scholar
• Bierhaus A., Chevion S., Chevion M., Hofmann M., Quehenberger P., Illmer T., Luther T., Berentshtein E., Tritschler H., Mueller M., Wahl P., Ziegler R., Nawroth P.P. Advanced glycation end product-induced activation of NF-κB is suppressed by α-lipoic acid in cultured endothelial cells. Diabetes 1997; 46: 1481–1490
   PubMed Web of Science ®Google Scholar
• Hofmann M.A., Schiekofer S., Isermann B., Kanitz M., Henkels M., Joswig M., Treusch A., Morcos M., Weiss T., Borcea V., Abdel Khalek A.K.M., Amiral J., Tritschler H., Ritz E., Wahl P., Ziegler R., Bierhaus A., Nawroth P.P. Peripheral blood mononuclear cells isolated from patients with diabetic nephropathy show increased activation of the oxidative-stress sensitive transcription factor NF-κB. Diabetologia 1999; 42: 222–232
   PubMed Web of Science ®Google Scholar
• Jacob S., Henriksen E.J., Tritschler H.J., Augustin H.J., Dietze G.J. Improvement of insulin-stimulated glucose-disposal in type 2 diabetes after repeated parenteral administration of thioctic acid. Experimental and Clinical Endocrinology and Diabetes 1996; 104: 284–288
   PubMed Web of Science ®Google Scholar
• Jacob S., Henriksen E.J., Tritschler H.J., Clancy D.E., Simon I., Schiemann A., Ulrich H., Jung W.I., Dietze G.J., Augustin H.J. α-lipoic acid enhances glucosedisposal in patients with type II diabetes. Arzneimittel-Forschung/Drug Research 1995; 45: 872–874
   PubMed Web of Science ®Google Scholar
• Konrad T., Vicini P., Kusterer K., Höflich A., Assadkhani A., Böhles H.J., Sewell A., Tritschler H.J., Cobelli C., Usadel K.H. α-Lipoic acid treatment decreases serum lactate and pyruvate concentrations and improves glucose effectiveness in lean and obese patients with Type 2 diabetes. Diabetes Care 1999; 22: 280–287
   PubMed Web of Science ®Google Scholar
• Borcea V., Nourooz-Zadeh J., Wolff S.P., Zumbach M., Hofmann M., Ulrich H., Wahl P., Ziegler R., Tritschler H., Halliwell B., Nawroth P.P. α-Lipoic acid decreases oxidative stress measures in patients with diabetes mellitus. Free Radicals in Biology and Medicine 1999, (in press)
   PubMedGoogle Scholar