Authors: Nigishi Hotta; Keigo Yasuda¹; Yasuhiro Sumita²; Takahisa Sano³; Hironobu Kakuta⁴; Makoto Nagashima⁵; Yoshinari Hayashi⁶; Masahiro Yamamoto⁷; Takaaki Wakao⁸; Makio Okuyama⁹; Masato Kobayashi¹⁰; Kouichi Mori¹¹

Source: Clinical Drug Investigation, Volume 24, Number 11, 2004 , pp. 671-680(10)

Publisher: Adis International

Abstract:

Objective: To evaluate the effects of fidarestat (SNK-860) on vibration perception threshold, as measured by C64 quantitative tuning fork (64Hz) analysis, as well as its effects on subjective symptoms in patients with diabetic polyneuro-pathy.

Design and setting: Open-label, prospective study conducted at 12 hospitals in the central area of Honshu, Japan.

Interventions: Fidarestat was administered at a dosage of 1mg once daily after breakfast for 28 weeks.

Main outcome measures: Vibration perception threshold of upper and lower extremities was determined using a C64 quantitative tuning fork, and measured at baseline and after 12 and 28 weeks of treatment. Subjective symptoms, including numbness, spontaneous pain and hypoaesthesia, were evaluated every 4 weeks.

Results: Subjective symptoms were evaluated in 22 patients, and vibration perception threshold data were available for 19 patients. Vibration perception threshold at baseline was negatively correlated with the severity of the following subjective symptoms: numbness in the upper limbs, and numbness, coldness and hot flushes, smarting pain causing difficulty walking and hypoaesthesia in the lower limbs. During treatment with fidarestat, vibration perception threshold increased significantly in the upper (p = 0.0017) and lower (p = 0.0001) limbs. The following symptoms were also significantly improved: severity of numbness in the lower limbs, heaviness in the foot, coldness and hot flushes in the lower limbs, smarting pain causing difficulty walking, sensation as if walking on sand, sensation as if walking on an uneven road, spontaneous pain in the lower limbs, and dizziness. Adverse events occurred in four patients.

Conclusion: Administration of fidarestat after breakfast was effective in significantly alleviating some symptoms of diabetic polyneuropathy. The C64 quantitative tuning fork analysis is useful in the diagnosis of diabetic polyneuropathy, and as a measure of the severity of the neuropathological symptoms of this condition.

Keywords: Aldose reductase inhibitors, therapeutic use; Fidarestat, therapeutic use; Research and development; Diabetic neuropathies, treatment

Document Type: Research article

Affiliations: 1: 3 Third Department of Internal Medicine, Gifu University School of Medicine, Gifu, Japan 10: 11 Department of Internal Medicine, Gamagori City Hospital, Gamagori, Japan 11: 12 Department of Internal Medicine, Kakegawa City General Hospital, Kakegawa, Japan 2: 4 Third Department of Internal Medicine, Mie University School of Medicine, Tsu, Japan 3: 2 Department of Metabolism and Endocrinology, Chubu Rosai Hospital, Nagoya, Japan 4: 5 Department of Internal Medicine, Aihoku Hospital, Konan, Japan 5: 6 Department of Internal Medicine, Kainan Hospital, Ama-gun, Japan 6: 7 Department of Internal Medicine, Kariya General Hospital, Kariya, Japan 7: 8 Department of Endocrinology and Metabolism, Anjo Kousei Hospital, Anjo, Japan 8: 9 Department of Internal Medicine, Ichinomiya City Hospital, Ichinomiya, Japan 9: 10 Department of Internal Medicine, Inazawa City Hospital, Inazawa, Japan

Publication date: 2004-01-01

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• By this author: Nigishi Hotta ;  Keigo Yasuda ;  Yasuhiro Sumita ;  Takahisa Sano ;  Hironobu Kakuta ;  Makoto Nagashima ;  Yoshinari Hayashi ;  Masahiro Yamamoto ;  Takaaki Wakao ;  Makio Okuyama ;  Masato Kobayashi ;  Kouichi Mori

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