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

Abstract EN

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.