Effect of Coenzyme Q ₁₀ on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ ₁₀ 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, three-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 CoQ ₁₀ (600 mg or 1200 mg) or matching placebo for 4 months.

Outcomes

The primary outcome was plasma oxidative stress, defined as plasma concentration of F ₂-isoprotanes. Secondary outcomes included plasma isofurans, cardiac biomarkers, pre-dialysis blood pressure, and safety/tolerability.

Measurements

F ₂-isoprostanes and isofurans were measured as plasma markers of oxidative stress, and N-terminal-pro-b-type natriuretic peptide and troponin T were measured as cardiac biomarkers at baseline, 1, 2, and 4 months.

Results

Among 80 patients randomized, 15 were excluded due to not completing at least one post-baseline study visit, and 65 were included in the primary intention-to-treat analysis. No treatment-related major adverse events occurred. Daily treatment with 1200 mg but not 600 mg CoQ ₁₀ significantly reduced plasma concentrations of F ₂-isoprostanes at 4 months compared to placebo (adjusted mean change −10.7 pg/ml [95% CI −7.1 to −14.3 pg/mL], P < 0.001; and −8.3 pg/ml [95% CI −5.5 to −11.0 pg/ml], P = 0.1, respectively). There were no significant effects of CoQ ₁₀ treatment on plasma isofurans, cardiac biomarker concentrations, or pre-dialysis 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 1200 mg of CoQ ₁₀ is safe and results in a reduction in plasma concentrations of F ₂-isoprostanes, a marker of oxidative stress. Future studies are needed to determine whether CoQ ₁₀ supplementation improves clinical outcomes for patients undergoing maintenance hemodialysis.