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Baseline characteristics of the omega‐3 fatty acids ( F ish oils) and A spirin in V ascular access OU tcomes in RE nal D isease ( FAVOURED ) study
Author(s) -
Viecelli Andrea K,
Pascoe Elaine M,
Polkinghorne Kevan R,
Hawley Carmel M,
PaulBrent PetaAnne,
Badve Sunil V,
Cass Alan,
Johnson David W,
Kerr Peter G,
Mori Trevor A,
Scaria Anish,
Hooi Seong L,
Ong Meng L,
Irish Ashley B
Publication year - 2016
Publication title -
nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 61
eISSN - 1440-1797
pISSN - 1320-5358
DOI - 10.1111/nep.12573
Subject(s) - medicine , aspirin , cohort , diabetes mellitus , kidney disease , overweight , randomized controlled trial , placebo , obesity , endocrinology , pathology , alternative medicine
Aim The F ish oils and A spirin in V ascular access OU tcomes in RE nal D isease ( 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 A ustralia, N ew Z ealand and the U nited K ingdom ( UK ). Method 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 A ustralian, N ew Z ealand 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.