BACKGROUND - Oxidative stress is highly prevalent in patients with end-stage renal disease and is linked to excess cardiovascular risk. Identifying therapies that reduce oxidative stress has the potential to improve cardiovascular outcomes in patients undergoing maintenance dialysis.
STUDY DESIGN - Placebo-controlled, 3-arm, double-blind, randomized, clinical trial.
SETTING & PARTICIPANTS - 65 patients undergoing thrice-weekly maintenance hemodialysis.
INTERVENTION - Patients were randomly assigned in a 1:1:1 ratio to receive once-daily coenzyme Q (CoQ; 600 or 1,200mg) or matching placebo for 4 months.
OUTCOMES - The primary outcome was plasma oxidative stress, defined as plasma concentration of F-isoprotanes. Secondary outcomes included levels of plasma isofurans, levels of cardiac biomarkers, predialysis blood pressure, and safety/tolerability.
MEASUREMENTS - F-isoprostanes and isofurans were measured as plasma markers of oxidative stress, and N-terminal pro-brain natriuretic peptide and troponin T were measured as cardiac biomarkers at baseline and 1, 2, and 4 months.
RESULTS - Of 80 randomly assigned patients, 15 were excluded due to not completing at least 1 postbaseline study visit and 65 were included in the primary intention-to-treat analysis. No treatment-related major adverse events occurred. Daily treatment with 1,200mg, but not 600mg, of CoQ significantly reduced plasma F-isoprostanes concentrations at 4 months compared to placebo (adjusted mean changes of -10.7 [95% CI, -7.1 to -14.3] pg/mL [P<0.001] and -8.3 [95% CI, -5.5 to -11.0] pg/mL [P=0.1], respectively). There were no significant effects of CoQ treatment on levels of plasma isofurans, cardiac biomarkers, or predialysis blood pressures.
LIMITATIONS - Study not powered to detect small treatment effects; difference in baseline characteristics among randomized groups.
CONCLUSIONS - In patients undergoing maintenance hemodialysis, daily supplementation with 1,200mg of CoQ is safe and results in a reduction in plasma concentrations of F-isoprostanes, a marker of oxidative stress. Future studies are needed to determine whether CoQ supplementation improves clinical outcomes for patients undergoing maintenance hemodialysis.
Copyright © 2016. Published by Elsevier Inc.