title: Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.
abstract: OBJECTIVE
  The Fish oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial investigated whether 3 months of omega-3 polyunsaturated fatty acids, either alone or in combination with aspirin, will effectively reduce primary access failure of de novo arteriovenous fistulae. This report presents the baseline characteristics of all study participants, examines whether study protocol amendments successfully increased recruitment of a broader and more representative haemodialysis cohort, including patients already receiving aspirin, and contrasts Malaysian participants with those from Australia, New Zealand and the United Kingdom (UK).
  
  
  METHODS
  This international, randomized, double-blind, placebo-controlled trial included patients older than 19 years with stage 4 or 5 chronic kidney disease currently receiving, or planned within 12 months to receive haemodialysis.
  
  
  RESULTS
  Participants (n = 568) were overweight (28.6 ± 7.3 kg/m(2) ), relatively young (54.8 ± 14.3 years), and predominantly male (63%) with a high prevalence of diabetes mellitus (46%) but low rate of ischaemic heart disease (8%). Sixty one percent were planned for lower arm arteriovenous fistula creation. Malaysian participants (n = 156) were younger (51.8 ± 13.6 years vs 57.1 ± 14.2 years, P < 0.001) with a higher prevalence of diabetes mellitus (65% vs 43%, P < 0.001), but less ischaemic heart disease (5% vs 14%, P < 0.01) compared with the combined Australian, New Zealand and UK cohort (n = 228). Protocol modifications allowing for inclusion of patients receiving aspirin increased the prevalence of co-morbidities compared with the original cohort.
  
  
  CONCLUSIONS
  The FAVOURED study participants, while mostly similar to patients in contemporary national registry reports and comparable recent clinical trials, were on average younger and had less ischaemic heart disease. These differences were reduced as a consequence of including patients already receiving aspirin.
authors.affiliation: Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
authors.forename: Andrea K
authors.initials: AK
authors.lastname: Viecelli
authors.affiliation: Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Pascoe
authors.affiliation: Department of Nephrology, Monash Medical Centre, Melbourne, Victoria, Australia.|School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.|Department of Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Kevan R
authors.initials: KR
authors.lastname: Polkinghorne
authors.affiliation: Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.|Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Carmel M
authors.initials: CM
authors.lastname: Hawley
authors.affiliation: Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Peta-Anne
authors.initials: PA
authors.lastname: Paul-Brent
authors.affiliation: Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.|Department of Nephrology, St George Hospital, Sydney, New South Wales, Australia.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Badve
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, Australia.
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.affiliation: Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.|Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: Department of Nephrology, Monash Medical Centre, Melbourne, Victoria, Australia.|Department of Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kerr
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Trevor A
authors.initials: TA
authors.lastname: Mori
authors.affiliation: Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Anish
authors.initials: A
authors.lastname: Scaria
authors.affiliation: Department of Medicine and Haemodialysis Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia.
authors.forename: Seong L
authors.initials: SL
authors.lastname: Hooi
authors.affiliation: Department of Nephrology, Penang Hospital, Georgetown, Malaysia.
authors.forename: Meng L
authors.initials: ML
authors.lastname: Ong
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia.|Department of Nephrology, Fiona Stanley Hospital, Perth, Western Australia, Australia.
authors.forename: Ashley B
authors.initials: AB
authors.lastname: Irish
mesh_terms: D000328:Adult; D000368:Aged; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage*; D001315:Australia / Q000453:epidemiology; D015897:Comorbidity; D004281:Docosahexaenoic Acids / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage*; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D015995:Prevalence; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index; D013927:Thrombosis / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D014654:Vascular Patency / Q000187:drug effects
chemical_list: D004338:Drug Combinations; D005343:Fibrinolytic Agents; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor; D001241:Aspirin
keywords: arteriovenous fistula; aspirin; fish oil; haemodialysis; vascular access outcome