Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial

Abstract

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 Q10 (CoQ10; 600 or 1,200mg) or matching placebo for 4 months.

Outcomes: The primary outcome was plasma oxidative stress, defined as plasma concentration of F2-isoprotanes. Secondary outcomes included levels of plasma isofurans, levels of cardiac biomarkers, predialysis blood pressure, and safety/tolerability.

Measurements: F2-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 CoQ10 significantly reduced plasma F2-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 CoQ10 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 CoQ10 is safe and results in a reduction in plasma concentrations of F2-isoprostanes, a marker of oxidative stress. Future studies are needed to determine whether CoQ10 supplementation improves clinical outcomes for patients undergoing maintenance hemodialysis.

Keywords: Oxidative stress; antioxidant; biomarker; cardiac function; cardiovascular risk; coenzyme Q(10) (CoQ(10)); dietary supplement; end-stage renal disease (ESRD); hemodialysis; predialysis blood pressure; randomized controlled trial.

Copyright © 2016. Published by Elsevier Inc.

Figures

Figure 1. Flow chart of study population, including the number of patients who were screened, gave consent, underwent randomization, completed the study treatment and were analyzed for the primary outcome

Figure 2. Mean Change in Plasma F2-Isoprostanes and Isofurans Concentrations from Baseline to Months 1, 2 and 4 of Follow-up, by Treatment Group

Values are least squares means adjusted for baseline measurements, age, sex, race, etiology of end-stage renal disease. Error bars represent ± standard error of the least squares mean. Asterisk indicates P