Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study

Jaime Hernández-Ojeda, Luis Miguel Román-Pintos, Adolfo Daniel Rodríguez-Carrízalez, Rogelio Troyo-Sanromán, Ernesto Germán Cardona-Muñoz, María del Pilar Alatorre-Carranza, Alejandra Guillermina Miranda-D&i...

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Autores principales:	Hernández-Ojeda J, Román-Pintos LM, Rodríguez-Carrízalez AD, Troyo-Sanromán R, Cardona-Muñoz EG, Alatorre-Carranza MP, Miranda-Díaz AG
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/931a42d47ad643abb250f4cc182dc37c
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spelling	oai:doaj.org-article:931a42d47ad643abb250f4cc182dc37c2021-12-02T01:15:00ZEffect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study1178-7007https://doaj.org/article/931a42d47ad643abb250f4cc182dc37c2014-09-01T00:00:00Zhttp://www.dovepress.com/effect-of-rosuvastatin-on-diabetic-polyneuropathy-a-randomized-double--peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007 Jaime Hernández-Ojeda, Luis Miguel Román-Pintos, Adolfo Daniel Rodríguez-Carrízalez, Rogelio Troyo-Sanromán, Ernesto Germán Cardona-Muñoz, María del Pilar Alatorre-Carranza, Alejandra Guillermina Miranda-Díaz Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Jalisco, México Background: Diabetic neuropathy affects 50%–66% of patients with diabetes mellitus. Oxidative stress generates nerve dysfunction by causing segmental demyelinization and axonal degeneration. Antioxidants are considered to be the only etiologic management for diabetic polyneuropathy, and statins such as rosuvastatin increase nitric oxide bioavailability and reduce lipid peroxidation. The aim of this study was to evaluate the antioxidant effect of rosuvastatin in diabetic polyneuropathy. Methods: We conducted a randomized, double-blind, placebo-controlled Phase IIa clinical trial in patients with type 2 diabetes and diabetic polyneuropathy (DPN) stage ≥1b. We allocated subjects to two parallel groups (1:1) that received rosuvastatin 20 mg or placebo for 12 weeks. Primary outcomes were neuropathic symptom score, disability score, and nerve conduction studies, and secondary outcomes were glycemic control, lipid and hepatic profile, lipid peroxidation, and nerve growth factor beta (NGF-β) levels. Results: Both groups were of similar age and duration since diagnosis of diabetes and DPN. We observed improvement of DPN in the rosuvastatin group from stage 2a (88.2%) to stage 1b (41.2%), improvement of neuropathic symptom score from 4.5±2 to 2.4±1.8, and significant (P=0.001) reductions of peroneal nerve conduction velocity (from 40.8±2.2 to 42.1±1.6 seconds) and lipid peroxidation (from 25.4±2 to 12.2±4.0 nmol/mL), with no significant change in glycemic control or β-NGF. Conclusion: The severity, symptoms, and nerve conduction parameters of DPN improved after 12 weeks of treatment with rosuvastatin. These beneficial effects appear to be attributable to reductions in lipid peroxidation and oxidative stress. Keywords: rosuvastatin, diabetic polyneuropathy, nerve conduction, oxidative stress, nerve growth factor betaHernández-Ojeda JRomán-Pintos LMRodríguez-Carrízalez ADTroyo-Sanromán RCardona-Muñoz EGAlatorre-Carranza MPMiranda-Díaz AGDove Medical PressarticleSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol 2014, Iss default, Pp 401-407 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Specialties of internal medicine RC581-951
spellingShingle	Specialties of internal medicine RC581-951 Hernández-Ojeda J Román-Pintos LM Rodríguez-Carrízalez AD Troyo-Sanromán R Cardona-Muñoz EG Alatorre-Carranza MP Miranda-Díaz AG Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
description	Jaime Hernández-Ojeda, Luis Miguel Román-Pintos, Adolfo Daniel Rodríguez-Carrízalez, Rogelio Troyo-Sanromán, Ernesto Germán Cardona-Muñoz, María del Pilar Alatorre-Carranza, Alejandra Guillermina Miranda-Díaz Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Jalisco, México Background: Diabetic neuropathy affects 50%–66% of patients with diabetes mellitus. Oxidative stress generates nerve dysfunction by causing segmental demyelinization and axonal degeneration. Antioxidants are considered to be the only etiologic management for diabetic polyneuropathy, and statins such as rosuvastatin increase nitric oxide bioavailability and reduce lipid peroxidation. The aim of this study was to evaluate the antioxidant effect of rosuvastatin in diabetic polyneuropathy. Methods: We conducted a randomized, double-blind, placebo-controlled Phase IIa clinical trial in patients with type 2 diabetes and diabetic polyneuropathy (DPN) stage ≥1b. We allocated subjects to two parallel groups (1:1) that received rosuvastatin 20 mg or placebo for 12 weeks. Primary outcomes were neuropathic symptom score, disability score, and nerve conduction studies, and secondary outcomes were glycemic control, lipid and hepatic profile, lipid peroxidation, and nerve growth factor beta (NGF-β) levels. Results: Both groups were of similar age and duration since diagnosis of diabetes and DPN. We observed improvement of DPN in the rosuvastatin group from stage 2a (88.2%) to stage 1b (41.2%), improvement of neuropathic symptom score from 4.5±2 to 2.4±1.8, and significant (P=0.001) reductions of peroneal nerve conduction velocity (from 40.8±2.2 to 42.1±1.6 seconds) and lipid peroxidation (from 25.4±2 to 12.2±4.0 nmol/mL), with no significant change in glycemic control or β-NGF. Conclusion: The severity, symptoms, and nerve conduction parameters of DPN improved after 12 weeks of treatment with rosuvastatin. These beneficial effects appear to be attributable to reductions in lipid peroxidation and oxidative stress. Keywords: rosuvastatin, diabetic polyneuropathy, nerve conduction, oxidative stress, nerve growth factor beta
format	article
author	Hernández-Ojeda J Román-Pintos LM Rodríguez-Carrízalez AD Troyo-Sanromán R Cardona-Muñoz EG Alatorre-Carranza MP Miranda-Díaz AG
author_facet	Hernández-Ojeda J Román-Pintos LM Rodríguez-Carrízalez AD Troyo-Sanromán R Cardona-Muñoz EG Alatorre-Carranza MP Miranda-Díaz AG
author_sort	Hernández-Ojeda J
title	Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title_short	Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title_full	Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title_fullStr	Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title_full_unstemmed	Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title_sort	effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled phase iia study
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/931a42d47ad643abb250f4cc182dc37c
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Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study

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