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

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...

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Autores principales: Hernández-Ojeda, Jaime, Román-Pintos, Luis Miguel, Rodríguez-Carrízalez, Adolfo Daniel, Troyo-Sanromán, Rogelio, Cardona-Muñoz, Ernesto Germán, Alatorre-Carranza, María del Pilar, Miranda-Díaz, Alejandra Guillermina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159311/
https://www.ncbi.nlm.nih.gov/pubmed/25214797
http://dx.doi.org/10.2147/DMSO.S65500
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author Hernández-Ojeda, Jaime
Román-Pintos, Luis Miguel
Rodríguez-Carrízalez, Adolfo Daniel
Troyo-Sanromán, Rogelio
Cardona-Muñoz, Ernesto Germán
Alatorre-Carranza, María del Pilar
Miranda-Díaz, Alejandra Guillermina
author_facet Hernández-Ojeda, Jaime
Román-Pintos, Luis Miguel
Rodríguez-Carrízalez, Adolfo Daniel
Troyo-Sanromán, Rogelio
Cardona-Muñoz, Ernesto Germán
Alatorre-Carranza, María del Pilar
Miranda-Díaz, Alejandra Guillermina
author_sort Hernández-Ojeda, Jaime
collection PubMed
description 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.
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spelling pubmed-41593112014-09-11 Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study Hernández-Ojeda, Jaime Román-Pintos, Luis Miguel Rodríguez-Carrízalez, Adolfo Daniel Troyo-Sanromán, Rogelio Cardona-Muñoz, Ernesto Germán Alatorre-Carranza, María del Pilar Miranda-Díaz, Alejandra Guillermina Diabetes Metab Syndr Obes Original Research 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. Dove Medical Press 2014-09-04 /pmc/articles/PMC4159311/ /pubmed/25214797 http://dx.doi.org/10.2147/DMSO.S65500 Text en © 2014 Hernández-Ojeda et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Hernández-Ojeda, Jaime
Román-Pintos, Luis Miguel
Rodríguez-Carrízalez, Adolfo Daniel
Troyo-Sanromán, Rogelio
Cardona-Muñoz, Ernesto Germán
Alatorre-Carranza, María del Pilar
Miranda-Díaz, Alejandra Guillermina
Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study
title 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_short 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
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159311/
https://www.ncbi.nlm.nih.gov/pubmed/25214797
http://dx.doi.org/10.2147/DMSO.S65500
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