Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study

Andrea K Viecelli, Elaine Pascoe, Kevan Polkinghorne, Carmel Hawley, Peta Paul-Brent, Sunil Badve, Alan Cass, David Johnson, Peter Kerr, T Mori, Anish Scaria, Hooi L Seong, Meng, Ashley Irish, FAVORED study team

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Aim: 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).

    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/m2), 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.

    Original languageEnglish
    Pages (from-to)217-228
    Number of pages12
    JournalNephrology
    Volume21
    Issue number3
    DOIs
    Publication statusPublished - 2016

    Fingerprint

    Fish Oils
    Omega-3 Fatty Acids
    Aspirin
    Blood Vessels
    Kidney
    Renal Dialysis
    Diabetes Mellitus
    Arteriovenous Fistula
    Chronic Renal Insufficiency
    New Zealand
    Fistula
    Registries
    Heart Diseases
    Fatty Acids
    Placebos
    Clinical Trials

    Cite this

    Viecelli, A. K., Pascoe, E., Polkinghorne, K., Hawley, C., Paul-Brent, P., Badve, S., ... FAVORED study team (2016). Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study. Nephrology, 21(3), 217-228. https://doi.org/10.1111/nep.12573
    Viecelli, Andrea K ; Pascoe, Elaine ; Polkinghorne, Kevan ; Hawley, Carmel ; Paul-Brent, Peta ; Badve, Sunil ; Cass, Alan ; Johnson, David ; Kerr, Peter ; Mori, T ; Scaria, Anish ; Seong, Hooi L ; Meng ; Irish, Ashley ; FAVORED study team. / Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study. In: Nephrology. 2016 ; Vol. 21, No. 3. pp. 217-228.
    @article{041770a806c44ecdb4fb93377501a989,
    title = "Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study",
    abstract = "Aim: 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). 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/m2), 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.",
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    author = "Viecelli, {Andrea K} and Elaine Pascoe and Kevan Polkinghorne and Carmel Hawley and Peta Paul-Brent and Sunil Badve and Alan Cass and David Johnson and Peter Kerr and T Mori and Anish Scaria and Seong, {Hooi L} and Meng and Ashley Irish and {FAVORED study team}",
    year = "2016",
    doi = "10.1111/nep.12573",
    language = "English",
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    Viecelli, AK, Pascoe, E, Polkinghorne, K, Hawley, C, Paul-Brent, P, Badve, S, Cass, A, Johnson, D, Kerr, P, Mori, T, Scaria, A, Seong, HL, Meng, Irish, A & FAVORED study team 2016, 'Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study', Nephrology, vol. 21, no. 3, pp. 217-228. https://doi.org/10.1111/nep.12573

    Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study. / Viecelli, Andrea K; Pascoe, Elaine; Polkinghorne, Kevan; Hawley, Carmel; Paul-Brent, Peta; Badve, Sunil; Cass, Alan; Johnson, David; Kerr, Peter; Mori, T; Scaria, Anish; Seong, Hooi L; Meng; Irish, Ashley; FAVORED study team.

    In: Nephrology, Vol. 21, No. 3, 2016, p. 217-228.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study

    AU - Viecelli, Andrea K

    AU - Pascoe, Elaine

    AU - Polkinghorne, Kevan

    AU - Hawley, Carmel

    AU - Paul-Brent, Peta

    AU - Badve, Sunil

    AU - Cass, Alan

    AU - Johnson, David

    AU - Kerr, Peter

    AU - Mori, T

    AU - Scaria, Anish

    AU - Seong, Hooi L

    AU - Meng, null

    AU - Irish, Ashley

    AU - FAVORED study team, null

    PY - 2016

    Y1 - 2016

    N2 - Aim: 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). 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/m2), 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.

    AB - Aim: 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). 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/m2), 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.

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