Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes

Purpose Aspirin and omega-3 fatty acids (FAs) are potential disease modifiers of age-related macular degeneration (AMD), but previous studies have produced inconsistent findings. Randomised evidence for the efficacy and safety of aspirin and omega-3 FAs on AMD is presented in this study.Design ASCEN...

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Main Authors: Praveen Patel, Rory Collins, Richard Peto, Mark Davies, Sanjiv Banerjee, David Simpson, John Anderson, Louise Bowman, Peter Scanlon, Amanda Adler, Andrew Farmer, Helen Cook, Laura Evans, Elizabeth Williamson, Louis Bolter, Jane Armitage, Peter Sandercock, Richard Gray, Nilesh Samani, Tasso Gazis, Richard Haynes, Arun Sachdev, Eric Wu, Elizabeth Wincott, Peter Sleight, Colin Baigent, Marion Mafham, Sarah Parish, Gavin Brown, Susan Hurley, Lynne Allsop, William Stevens, Theingi Aung, Allen Young, Emily Sammons, Georgina Buck, Imen Hammami, Jill Barton, Jonathan Bodansky, Roger McPherson, Lucy Fletcher, Murphy Kevin, Ryonfa Lee, Sandra Pickworth, Monica Willett, Michael Lay, Ola Murawska, Karen Melham, Jonathan Latham-Mollart, Anna Brewer, Mike Olson, Jude Kay, Alisha Griffiths, Helen Clayton, Philip Kirby, Mike Pennington, Dominic Clarke, Jenny Anslow, Alex Hallam, Jenny Witts, Sarah Egan, Alex Wharton, Amy Derbyshire, Katherine Hepplestone, Sujit Mithra, Su Oliver, Pauline Wiatrak-Olszewska, Kelly Alvey, Nick Gregory, Priyai Parkinson, Prema Maharajan, Rachel McFee, Donna Sowter, John Featonby, Richard Furnival, Helen Lipinski, Hazel Benjamin, Tanisha McAfee, Emma Payne Payne, Liz Still
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/2/e090605.full
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author Praveen Patel
Rory Collins
Richard Peto
Mark Davies
Sanjiv Banerjee
David Simpson
John Anderson
Louise Bowman
Peter Scanlon
Amanda Adler
Andrew Farmer
Helen Cook
Laura Evans
Elizabeth Williamson
Louis Bolter
Jane Armitage
Peter Sandercock
Richard Gray
Nilesh Samani
Tasso Gazis
Richard Haynes
Arun Sachdev
Eric Wu
Elizabeth Wincott
Peter Sleight
Colin Baigent
Marion Mafham
Sarah Parish
Gavin Brown
Susan Hurley
Lynne Allsop
William Stevens
Theingi Aung
Allen Young
Emily Sammons
Georgina Buck
Imen Hammami
Jill Barton
Jonathan Bodansky
Roger McPherson
Lucy Fletcher
Murphy Kevin
Ryonfa Lee
Sandra Pickworth
Monica Willett
Michael Lay
Ola Murawska
Karen Melham
Jonathan Latham-Mollart
Anna Brewer
Mike Olson
Jude Kay
Alisha Griffiths
Helen Clayton
Philip Kirby
Mike Pennington
Dominic Clarke
Jenny Anslow
Alex Hallam
Jenny Witts
Sarah Egan
Alex Wharton
Amy Derbyshire
Katherine Hepplestone
Sujit Mithra
Su Oliver
Pauline Wiatrak-Olszewska
Kelly Alvey
Nick Gregory
Priyai Parkinson
Prema Maharajan
Rachel McFee
Donna Sowter
John Featonby
Richard Furnival
Helen Lipinski
Hazel Benjamin
Tanisha McAfee
Emma Payne Payne
Liz Still
author_facet Praveen Patel
Rory Collins
Richard Peto
Mark Davies
Sanjiv Banerjee
David Simpson
John Anderson
Louise Bowman
Peter Scanlon
Amanda Adler
Andrew Farmer
Helen Cook
Laura Evans
Elizabeth Williamson
Louis Bolter
Jane Armitage
Peter Sandercock
Richard Gray
Nilesh Samani
Tasso Gazis
Richard Haynes
Arun Sachdev
Eric Wu
Elizabeth Wincott
Peter Sleight
Colin Baigent
Marion Mafham
Sarah Parish
Gavin Brown
Susan Hurley
Lynne Allsop
William Stevens
Theingi Aung
Allen Young
Emily Sammons
Georgina Buck
Imen Hammami
Jill Barton
Jonathan Bodansky
Roger McPherson
Lucy Fletcher
Murphy Kevin
Ryonfa Lee
Sandra Pickworth
Monica Willett
Michael Lay
Ola Murawska
Karen Melham
Jonathan Latham-Mollart
Anna Brewer
Mike Olson
Jude Kay
Alisha Griffiths
Helen Clayton
Philip Kirby
Mike Pennington
Dominic Clarke
Jenny Anslow
Alex Hallam
Jenny Witts
Sarah Egan
Alex Wharton
Amy Derbyshire
Katherine Hepplestone
Sujit Mithra
Su Oliver
Pauline Wiatrak-Olszewska
Kelly Alvey
Nick Gregory
Priyai Parkinson
Prema Maharajan
Rachel McFee
Donna Sowter
John Featonby
Richard Furnival
Helen Lipinski
Hazel Benjamin
Tanisha McAfee
Emma Payne Payne
Liz Still
collection DOAJ
description Purpose Aspirin and omega-3 fatty acids (FAs) are potential disease modifiers of age-related macular degeneration (AMD), but previous studies have produced inconsistent findings. Randomised evidence for the efficacy and safety of aspirin and omega-3 FAs on AMD is presented in this study.Design ASCEND-Eye is a substudy of eye effects in the 2×2 factorial design ASCEND (A Study of Cardiovascular Events iN Diabetes) double-blind, randomised, placebo-controlled trial for the primary prevention of cardiovascular events. Reports of AMD diagnoses were sourced from 6 monthly ASCEND follow-up questionnaires and a Visual Function Questionnaire.Participants 15 480 UK adults at least 40 years of age with diabetes but no evident cardiovascular disease.Interventions 100 mg aspirin daily versus placebo and, separately, 1 g omega-3 FAs daily versus placebo.Main outcome measure The first post-randomisation reports of AMD.Results During 7.4 years of follow-up, 122 (1.6%) participants randomised to aspirin were reported as having AMD, compared with 138 (1.8%) randomised to placebo (rate ratio 0.88; 95% CI 0.69 to 1.12; p=0.31). AMD occurred in 130 (1.7%) participants randomised to omega-3 FAs, compared with 130 (1.7%) randomised to placebo (rate ratio 0.99; 95% CI 0.78 to 1.27; p=0.99).Conclusion No clinically-meaningful effects of aspirin or omega-3 FAs on AMD were found. Although the study had very limited statistical power to detect clinically relevant effects, these data overcome some methodological limitations of previous observational studies, providing randomised evidence of both treatments on AMD, which could contribute to future meta-analyses.Trial registration number ISRCTN60635500 and NCT00135226.
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spelling doaj-art-e41ae65c2e6140e280ded2e512379a9b2025-08-20T02:03:47ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-090605Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes Praveen PatelRory CollinsRichard PetoMark DaviesSanjiv BanerjeeDavid SimpsonJohn AndersonLouise Bowman0Peter ScanlonAmanda AdlerAndrew FarmerHelen CookLaura EvansElizabeth WilliamsonLouis BolterJane Armitage1Peter SandercockRichard GrayNilesh SamaniTasso GazisRichard HaynesArun SachdevEric WuElizabeth WincottPeter SleightColin BaigentMarion MafhamSarah Parish2Gavin BrownSusan HurleyLynne AllsopWilliam Stevens3Theingi AungAllen YoungEmily Sammons4Georgina Buck5Imen Hammami6Jill BartonJonathan BodanskyRoger McPhersonLucy FletcherMurphy KevinRyonfa LeeSandra PickworthMonica WillettMichael LayOla MurawskaKaren MelhamJonathan Latham-MollartAnna BrewerMike OlsonJude KayAlisha GriffithsHelen ClaytonPhilip KirbyMike PenningtonDominic ClarkeJenny AnslowAlex HallamJenny WittsSarah EganAlex WhartonAmy DerbyshireKatherine HepplestoneSujit MithraSu OliverPauline Wiatrak-OlszewskaKelly AlveyNick GregoryPriyai ParkinsonPrema MaharajanRachel McFeeDonna SowterJohn FeatonbyRichard FurnivalHelen LipinskiHazel BenjaminTanisha McAfeeEmma Payne PayneLiz StillNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKNuffield Department of Population Health, University of Oxford, Oxford, UKPurpose Aspirin and omega-3 fatty acids (FAs) are potential disease modifiers of age-related macular degeneration (AMD), but previous studies have produced inconsistent findings. Randomised evidence for the efficacy and safety of aspirin and omega-3 FAs on AMD is presented in this study.Design ASCEND-Eye is a substudy of eye effects in the 2×2 factorial design ASCEND (A Study of Cardiovascular Events iN Diabetes) double-blind, randomised, placebo-controlled trial for the primary prevention of cardiovascular events. Reports of AMD diagnoses were sourced from 6 monthly ASCEND follow-up questionnaires and a Visual Function Questionnaire.Participants 15 480 UK adults at least 40 years of age with diabetes but no evident cardiovascular disease.Interventions 100 mg aspirin daily versus placebo and, separately, 1 g omega-3 FAs daily versus placebo.Main outcome measure The first post-randomisation reports of AMD.Results During 7.4 years of follow-up, 122 (1.6%) participants randomised to aspirin were reported as having AMD, compared with 138 (1.8%) randomised to placebo (rate ratio 0.88; 95% CI 0.69 to 1.12; p=0.31). AMD occurred in 130 (1.7%) participants randomised to omega-3 FAs, compared with 130 (1.7%) randomised to placebo (rate ratio 0.99; 95% CI 0.78 to 1.27; p=0.99).Conclusion No clinically-meaningful effects of aspirin or omega-3 FAs on AMD were found. Although the study had very limited statistical power to detect clinically relevant effects, these data overcome some methodological limitations of previous observational studies, providing randomised evidence of both treatments on AMD, which could contribute to future meta-analyses.Trial registration number ISRCTN60635500 and NCT00135226.https://bmjopen.bmj.com/content/15/2/e090605.full
spellingShingle Praveen Patel
Rory Collins
Richard Peto
Mark Davies
Sanjiv Banerjee
David Simpson
John Anderson
Louise Bowman
Peter Scanlon
Amanda Adler
Andrew Farmer
Helen Cook
Laura Evans
Elizabeth Williamson
Louis Bolter
Jane Armitage
Peter Sandercock
Richard Gray
Nilesh Samani
Tasso Gazis
Richard Haynes
Arun Sachdev
Eric Wu
Elizabeth Wincott
Peter Sleight
Colin Baigent
Marion Mafham
Sarah Parish
Gavin Brown
Susan Hurley
Lynne Allsop
William Stevens
Theingi Aung
Allen Young
Emily Sammons
Georgina Buck
Imen Hammami
Jill Barton
Jonathan Bodansky
Roger McPherson
Lucy Fletcher
Murphy Kevin
Ryonfa Lee
Sandra Pickworth
Monica Willett
Michael Lay
Ola Murawska
Karen Melham
Jonathan Latham-Mollart
Anna Brewer
Mike Olson
Jude Kay
Alisha Griffiths
Helen Clayton
Philip Kirby
Mike Pennington
Dominic Clarke
Jenny Anslow
Alex Hallam
Jenny Witts
Sarah Egan
Alex Wharton
Amy Derbyshire
Katherine Hepplestone
Sujit Mithra
Su Oliver
Pauline Wiatrak-Olszewska
Kelly Alvey
Nick Gregory
Priyai Parkinson
Prema Maharajan
Rachel McFee
Donna Sowter
John Featonby
Richard Furnival
Helen Lipinski
Hazel Benjamin
Tanisha McAfee
Emma Payne Payne
Liz Still
Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
BMJ Open
title Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
title_full Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
title_fullStr Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
title_full_unstemmed Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
title_short Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
title_sort effects of aspirin and omega 3 fatty acids on age related macular degeneration in ascend eye a randomised placebo controlled trial in a population with diabetes
url https://bmjopen.bmj.com/content/15/2/e090605.full
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