PMID- 26290682
OWN - NLM
STAT- MEDLINE
DCOM- 20160518
LR  - 20220409
IS  - 1942-0994 (Electronic)
IS  - 1942-0900 (Print)
IS  - 1942-0994 (Linking)
VI  - 2015
DP  - 2015
TI  - Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic 
      Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
PG  - 756294
LID - 10.1155/2015/756294 [doi]
LID - 756294
AB  - OBJECTIVE: To evaluate the effects of ezetimibe/simvastatin (EZE/SIMV) and 
      rosuvastatin (ROSUV) on oxidative stress (OS) markers in patients with diabetic 
      polyneuropathy (DPN). METHODS: We performed a randomized, double-blind, 
      placebo-controlled phase III clinical trial in adult patients with Type 2 
      Diabetes Mellitus (T2DM) and DPN, as evaluated by composite scores and nerve 
      conduction studies (NCS). Seventy-four subjects with T2DM were allocated 
      1 : 1 : 1 to placebo, EZE/SIMV 10/20 mg, or ROSUV 20 mg for 16 weeks. All 
      patients were assessed before and after treatment: primary outcomes were lipid 
      peroxidation (LPO), and nitric oxide (NO) surrogate levels in plasma; secondary 
      outcomes included NCS, neuropathic symptom scores, and metabolic parameters. Data 
      were expressed as mean +/- SD or SEM, frequencies, and percentages; we used 
      nonparametric analysis. RESULTS: LPO levels were reduced in both statin arms 
      after 16 weeks of treatment (p < 0.05 versus baseline), without changes in the 
      placebo group. NO levels were not significantly affected by statin treatment, 
      although a trend towards significance concerning increased NO levels was noted in 
      both statin arms. No significant changes were observed for the NCS or composite 
      scores. DISCUSSION: EZE/SIMV and ROSUV are superior to placebo in reducing LPO in 
      subjects with T2DM suffering from polyneuropathy. This trial is registered with 
      NCT02129231.
FAU - Villegas-Rivera, Geannyne
AU  - Villegas-Rivera G
AD  - Instituto de Investigacion Clinica de Occidente, 45030 Guadalajara, JAL, Mexico.
FAU - Roman-Pintos, Luis Miguel
AU  - Roman-Pintos LM
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
FAU - Cardona-Munoz, Ernesto German
AU  - Cardona-Munoz EG
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
FAU - Arias-Carvajal, Oscar
AU  - Arias-Carvajal O
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
FAU - Rodriguez-Carrizalez, Adolfo Daniel
AU  - Rodriguez-Carrizalez AD
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
FAU - Troyo-Sanroman, Rogelio
AU  - Troyo-Sanroman R
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
FAU - Pacheco-Moises, Fermin Paul
AU  - Pacheco-Moises FP
AD  - Departamento de Farmacobiologia, Centro Universitario de Ciencias Exactas e 
      Ingenierias, Universidad de Guadalajara, 44100 Guadalajara, JAL, Mexico.
FAU - Moreno-Ulloa, Aldo
AU  - Moreno-Ulloa A
AD  - Seccion de Estudios de Posgrado, Escuela Superior de Medicina, Instituto 
      Politecnico Nacional, 11340 Ciudad de Mexico, DF, Mexico ; Department of 
      Medicine, University of California, San Diego, CA 92093, USA.
FAU - Miranda-Diaz, Alejandra Guillermina
AU  - Miranda-Diaz AG
AD  - Instituto de Terapeutica Experimental y Clinica, Departamento de Fisiologia, 
      Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 
      Guadalajara, JAL, Mexico.
LA  - eng
SI  - ClinicalTrials.gov/NCT02129231
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150728
PL  - United States
TA  - Oxid Med Cell Longev
JT  - Oxidative medicine and cellular longevity
JID - 101479826
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - AGG2FN16EV (Simvastatin)
RN  - EOR26LQQ24 (Ezetimibe)
SB  - IM
MH  - Diabetic Neuropathies/*drug therapy
MH  - Double-Blind Method
MH  - Ezetimibe/administration & dosage/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & 
      dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Rosuvastatin Calcium/administration & dosage/*therapeutic use
MH  - Simvastatin/administration & dosage/*therapeutic use
PMC - PMC4531178
EDAT- 2015/08/21 06:00
MHDA- 2016/05/19 06:00
PMCR- 2015/07/28
CRDT- 2015/08/21 06:00
PHST- 2015/05/28 00:00 [received]
PHST- 2015/07/06 00:00 [accepted]
PHST- 2015/08/21 06:00 [entrez]
PHST- 2015/08/21 06:00 [pubmed]
PHST- 2016/05/19 06:00 [medline]
PHST- 2015/07/28 00:00 [pmc-release]
AID - 10.1155/2015/756294 [doi]
PST - ppublish
SO  - Oxid Med Cell Longev. 2015;2015:756294. doi: 10.1155/2015/756294. Epub 2015 Jul 
      28.