Titre du document / Document title

Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy: A 52-week multicenter placebo-controlled double-blind parallel group study

Auteur(s) / Author(s)

Diabetic Neuropathy Study Group
HOTTA Nigishi ⁽¹⁾ ; TOYOTA Takayoshi ⁽²⁾ ; MATSUOKA Kempei ⁽³⁾ ; SHIGETA Yukio ⁽⁴⁾ ; KIKKAWA Ryuichi ⁽⁵⁾ ; KANEKO Toshio ⁽⁶⁾ ; TAKAHASHI Akira ⁽⁷⁾ ; SUGIMURA Kimiya ⁽⁸⁾ ; KOIKE Yasuo ⁽⁹⁾ ; ISHII Jun ⁽¹⁰⁾ ; SAKAMOTO Nobuo ⁽¹¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Third Department of Internal Medicine, Nagoya University School of Medicine, Nagoya, JAPON
⁽²⁾ Third Department of Internal Medicine, School of Medicine, Tohoku University, Sendai, JAPON
⁽³⁾ Department of Internal Medicine, Tokyo Saiseikai Central Hospital, Tokyo, JAPON
⁽⁴⁾ Shiga University of Medical Science, Ohtsu, JAPON
⁽⁵⁾ Third Department of Medicine, Shiga University of Medical Science, Ohtsu, JAPON
⁽⁶⁾ Yamaguchi Rosai Hospital, Ube, JAPON
⁽⁷⁾ Tokai Central Hospital, Kagamigahara, JAPON
⁽⁸⁾ Nagoya University College of Medical Technology, Nagoya, JAPON
⁽⁹⁾ Neurophysiology Section, Department of Examination, Nagoya University, Nagoya, JAPON
⁽¹⁰⁾ Fourth Department of Internal Medicine, Saitama Medical School, Saitama, JAPON
⁽¹¹⁾ Chubu Rosai Hospital, Nagoya, JAPON

Résumé / Abstract

OBJECTIVE The purpose of this study was to evaluate the efficacy of fidarestat, a novel aldose reductase BAR) inhibitor, in a double-blind placebo controlled study in patients with type 1 and type 2 diabetes and associated peripheral neuropathy. RESEARCH DESIGN AND METHODS - A total of 279 patients with diabetic neuropathy were treated with placebo or fidarestat at a daily dose of 1 mg for 52 weeks. The efficacy evaluation was based on change in electrophysiological measurements of median and tibial motor nerve conduction velocity, F-wave minimum latency, F-wave conduction velocity (FCV), and median sensory nerve conduction velocity (forearm and distal), as well as an assessment of subjective symptoms. RESULTS - Over the course of the study, live of the eight electrophysiological measures assessed showed significant improvement from baseline in the fidarestat-treated group, whereas no measure showed significant deterioration. In contrast, in the placebo group, no electrophysiological measure was improved, and one measure significantly deteriorated (i e., median nerve FCV). At the study conclusion, the fidarestat-treated group was significantly improved compared with the placebo group in two electrophysiological measures (i.e., median nerve FCV and minimal latency) Subjective symptoms (including numbness, spontaneous pain, sensation of rigidity, paresthesia in the sole upon walking, heaviness in the foot, and hypesthesia) benefited from fidarestal treatment, and all were significantly improved in the treated versus placebo group at the study conclusion. At the dose used, fidarestat was well tolerated, with an adverse event profile that did not significantly differ from that seen in the placebo group. CONCLUSIONS - The effects of fidarestat-treatment on nerve conduction and the subjective symptoms of diabetic neuropathy provide evidence that this treatment alters the progression of diabetic neuropathy.

Revue / Journal Title

Diabetes care   ISSN 0149-5992   CODEN DICAD2 

Source / Source

2001, vol. 24, n^o10, pp. 1776-1782 (34 ref.)

Langue / Language

Anglais

Editeur / Publisher

American Diabetes Association, Alexandria, VA, ETATS-UNIS  (1978) (Revue)

Mots-clés anglais / English Keywords

Endocrinopathy ; Peripheral nerve disease ; Nervous system diseases ; Enzyme ; Oxidoreductases ; Human ; Multicenter study ; Complication ; Diabetes mellitus ; Peripheral neuropathy ; Treatment efficiency ; Treatment ; Chemotherapy ; Aldehyde reductase ; Enzyme inhibitor ; Fidarestat ;

Mots-clés français / French Keywords

Endocrinopathie ; Nerf périphérique pathologie ; Système nerveux pathologie ; Enzyme ; Oxidoreductases ; Homme ; Etude multicentrique ; Complication ; Diabète ; Neuropathie périphérique ; Efficacité traitement ; Traitement ; Chimiothérapie ; Aldehyde reductase ; Inhibiteur enzyme ; Fidarestat ;

Mots-clés espagnols / Spanish Keywords

Endocrinopatía ; Nervio periférico patología ; Sistema nervioso patología ; Enzima ; Oxidoreductases ; Hombre ; Estudio multicéntrico ; Complicación ; Diabetes ; Neuropatía periférica ; Eficacia tratamiento ; Tratamiento ; Quimioterapia ; Aldehyde reductase ; Inhibidor enzima ; Fidarestat ;

Localisation / Location

INIST-CNRS, Cote INIST : 18054, 35400009974602.0130