Evidence map›Paper›PMID 26290682›Full record

Trial reportOxidative medicine and cellular longevity2015

Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Geannyne Villegas-Rivera, Luis Miguel Román-Pintos, Ernesto Germán Cardona-Muñoz, Oscar Arias-Carvajal, Adolfo Daniel Rodríguez-Carrizalez, Rogelio Troyo-Sanromán, Fermín Paul Pacheco-Moisés, Aldo Moreno-Ulloa, Alejandra Guillermina Miranda-Díaz

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Oxidative medicine and cellular longevity, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02129231. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02129231 phase2completed

Ezetimibe/Simvastatin and Rosuvastatin for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy: a Randomized, Double Blinded, Placebo Controlled Clinical Trial

Ran2012Enrolled74Registered outcomes9Posted comparisons0ConditionsDiabetic Polyneuropathy, Oxidative StressArmscalcined magnesia, ezetimibe/simvastatin, Rosuvastatin
PMID 22595020other papers from this trial
Open the trial in the graph
NCT06131918 phase2completednot on this mapstarted 2023, after this paper: background citation

Assessment of Resveratrol, Alpha Lipoic Acid and Superoxide Dismutase on Oxidative Stress Biomarkers in Type 2 Diabetes Mellitus Patients With Neuropathy: A Randomized Control Trial

TypeinterventionalSponsorKhyber Medical University PeshawarRan2023 to 2024Enrolled100ConditionsPeripheral Diabetic NeuropathyArmsResveratrol, Alpha lipoic acid, Super oxide dismutase, Resveratrol, Alpha lipoic acid, Super Oxide Dismutase
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. The Role of Oxidative Stress in Peripheral Neuropathy.Journal of molecular neuroscience : MN · 2020
    Pooled it
  4. Pooled it
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023
    Review
  15. Review
  16. Review
  17. Neurobiological Opportunities in Diabetic Polyneuropathy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Geannyne Villegas-RiveraInstituto de Investigación Clínica de Occidente, 45030 Guadalajara, JAL, Mexico.
Luis Miguel Román-PintosInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Ernesto Germán Cardona-MuñozInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Oscar Arias-CarvajalInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Adolfo Daniel Rodríguez-CarrizalezInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Rogelio Troyo-SanrománInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Fermín Paul Pacheco-MoisésDepartamento de Farmacobiología, Centro Universitario de Ciencias Exactas e Ingenierías, Universidad de Guadalajara, 44100 Guadalajara, JAL, Mexico.
Aldo Moreno-UlloaSección de Estudios de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, 11340 Ciudad de México, DF, Mexico ; Department of Medicine, University of California, San Diego, CA 92093, USA.
Alejandra Guillermina Miranda-DíazInstituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, 44340 Guadalajara, JAL, Mexico.
Universidad de Guadalajara · MXUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effects of ezetimibe/simvastatin (EZE/SIMV) and rosuvastatin (ROSUV) on oxidative stress (OS) markers in patients with diabetic polyneuropathy (DPN).

methodsWe 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.

resultsLPO 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.

Indexed as

Diabetic NeuropathiesDouble-Blind MethodEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedRosuvastatin CalciumSimvastatinEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumSimvastatin

Identifiers

PMID26290682
PMCPMC4531178
OpenAlexW1562269843

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.