Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial.
What this study found
Daily CoQ10 at 1,200 mg reduced plasma F2-isoprostanes, the prespecified oxidative stress marker, compared with placebo, while 600 mg did not. At 4 months, F2-isoprostanes were 47.5 (33.2-61.8) with 1,200 mg versus 45.1 (36.6-53.6) with placebo, with p=0.002; the 600 mg group was 39.2 (30.9-47.6) with p=0.3 versus placebo. There were no significant differences versus placebo for isofurans, troponin T, NT-proBNP, or predialysis systolic or diastolic blood pressure in the primary analysis. The treatment was reported as safe, although some per-protocol analyses suggested possible reductions in…
- Study & population
- Randomized, placebo-controlled trial in adults with end-stage renal disease receiving thrice-weekly maintenance hemodialysis at outpatient dialysis facilities in the Seattle metropolitan area.
- Intervention
- Participants were assigned to oral coenzyme Q10 as chewable wafers for 4 months, at either 600 mg/day or 1,200 mg/day, compared with matching placebo wafers.
- Key limitation
- The trial was small within each active arm, lasted only 4 months, and was not powered for clinical outcomes.
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Open PDFOriginal 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.