title: Effect of Coenzyme Q10on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10Biomarker 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.
  
  
  METHODS
  Placebo-controlled, 3-arm, double-blind, randomized, clinical trial.
  
  
  METHODS
  65 patients undergoing thrice-weekly maintenance hemodialysis.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  METHODS
  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 CoQ10significantly 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 CoQ10treatment on levels of plasma isofurans, cardiac biomarkers, or predialysis blood pressures.
  
  
  CONCLUSIONS
  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 CoQ10is safe and results in a reduction in plasma concentrations of F2-isoprostanes, a marker of oxidative stress. Future studies are needed to determine whether CoQ10supplementation improves clinical outcomes for patients undergoing maintenance hemodialysis.
authors.affiliation: Kidney Research Institute, Seattle, WA; Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Rivara
authors.affiliation: Kidney Research Institute, Seattle, WA; Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA.
authors.forename: Catherine K
authors.initials: CK
authors.lastname: Yeung
authors.affiliation: Kidney Research Institute, Seattle, WA; Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA.
authors.forename: Cassianne
authors.initials: C
authors.lastname: Robinson-Cohen
authors.affiliation: Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Phillips
authors.affiliation: Kidney Research Institute, Seattle, WA.
authors.forename: John
authors.initials: J
authors.lastname: Ruzinski
authors.affiliation: Kidney Research Institute, Seattle, WA.
authors.forename: Denise
authors.initials: D
authors.lastname: Rock
authors.affiliation: Kidney Research Institute, Seattle, WA.
authors.forename: Lori
authors.initials: L
authors.lastname: Linke
authors.affiliation: Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA; Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA.
authors.forename: Danny D
authors.initials: DD
authors.lastname: Shen
authors.affiliation: Division of Nephrology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.
authors.forename: T Alp
authors.initials: TA
authors.lastname: Ikizler
authors.affiliation: Kidney Research Institute, Seattle, WA; Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA. Electronic address: jhimmelfarb@nephrology.washington.edu.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Himmelfarb
mesh_terms: D015415:Biomarkers; D004311:Double-Blind Method; D005260:Female; D006321:Heart / Q000503:physiopathology*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000378:metabolism / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects*; D010865:Pilot Projects; D006435:Renal Dialysis; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000494:pharmacology
chemical_list: D015415:Biomarkers; D014451:Ubiquinone; C024989:coenzyme Q10
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