ASCEND-Eye
Emily Sammons, Georgina Buck, Louise Bowman, William M. Stevens, Imen Hammami, Sarah Parish, Jane Armitage, Emily Sammons, Louise Bowman, William M. Stevens, Georgina Buck, Imen Hammami, Sarah Parish, Jane Armitage, Rory Collins, Jane Armitage, Jill Barton, David Simpson, Amanda Adler, Theingi Aung, Colin Baigent, H. J. Bodansky, Andrew Farmer, Richard Haynes, R. McPherson, Marion Mafham, H.A.W. Neil, Nilesh J. Samani, Peter Sleight, Peter L. Weissberg, Peter Sandercock, Hertzel C. Gerstein, Richard Gray, Charles H. Hennekens, L. Fletcher, Kevin J. Murphy, Seth Hurley, Richard K. Lee, S. Pickworth, Melissa Willett, M. Wincott, M Lay, Gemma Buck, Anna Murawska, William Stevens, Karl Wallendszus, Allen Young, Imen Hammami, Gregor J. Brown, John Latham-Mollart, Anthony Brewer, Peter H. Scanlon, Priyanka Patel, Mary C. Olson, Jonathan Kay, Somnath Banerjee, L. Evans, Alex Davies, Malcolm Griffiths, Helena Clayton, Philip Kirby, Mark Pennington, Damian Clarke, June A. Anslow, Alistair Hallam, James Witts, Sarah J. Egan, A. Wharton, Amit Sachdev, A. Derbyshire, Esther Williamson, K. Hepplestone, S. Mithra, Scott R. J. Oliver, P. Wiatrak-Olszewska, Tasso Gazis, K. Alvey, E.Q. Wu, Helen Cook, N. Gregory, P. M. Saz Parkinson, Jane Anderson, Louis Bolter, P. Maharajan, Robin B. McFee, Lynne Allsop, D. Sowter, David Hodgson, Jonathan Thow, J. Featonby, Ronald A. Furnival, H. Lipinski, H. Benjamin, Tim McAfee, Emily Payne, L. Still
Abstract
Purpose Preclinical studies support a protective role for omega-3 fatty acids (FAs) on diabetic retinopathy (DR), but these observations have not been confirmed in randomized trials. We present randomized evidence for the effects of omega-3 FAs on DR outcomes. Design A substudy of the A Study of Cardiovascular Events iN Diabetes (ASCEND) double-blind, randomized, placebo-controlled trial of 1 g omega-3 fatty acids (containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid) daily for the primary prevention of serious cardiovascular events, in 15 480 UK adults at least 40 years of age, with diabetes. Participants Fifteen thousand four hundred eighty adults at least 40 years of age from the United Kingdom with diabetes from the ASCEND cohort. Methods Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review. Log-rank and stratified log-rank methods were used for intention-to-treat analyses of time until the main outcomes of interest. Main Outcome Measures The primary efficacy endpoint was time to the first postrandomization recording of referable disease, a composite of referable retinopathy (R2 or R3a/s) or referable maculopathy (M1) based on the grading criteria defined by the United Kingdom National Screening Committee. Secondary and tertiary outcomes included the referable disease outcome stratified by the severity of DR at baseline, any progression in retinopathy grade, and incident diabetic maculopathy. Results Linkage data were obtained for 7360 participants (48% of those who were randomized in ASCEND). During their mean follow-up of 6.5 years, 548 participants (14.8%) had a referable disease event in the omega-3 FAs group, compared with 513 participants (13.9%) in the placebo group (rate ratio, 1.07; 95% confidence interval, 0.95–1.20; P = 0.29). There were no statistically significant between-group differences in the proportion of events for either of the secondary or tertiary outcomes. Conclusions Representing the largest prospective test of its kind to date, these data exclude any clinically meaningful benefits of 1 g daily omega-3 FAs on DR. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. Preclinical studies support a protective role for omega-3 fatty acids (FAs) on diabetic retinopathy (DR), but these observations have not been confirmed in randomized trials. We present randomized evidence for the effects of omega-3 FAs on DR outcomes. A substudy of the A Study of Cardiovascular Events iN Diabetes (ASCEND) double-blind, randomized, placebo-controlled trial of 1 g omega-3 fatty acids (containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid) daily for the primary prevention of serious cardiovascular events, in 15 480 UK adults at least 40 years of age, with diabetes. Fifteen thousand four hundred eighty adults at least 40 years of age from the United Kingdom with diabetes from the ASCEND cohort. Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review. Log-rank and stratified log-rank methods were used for intention-to-treat analyses of time until the main outcomes of interest. The primary efficacy endpoint was time to the first postrandomization recording of referable disease, a composite of referable retinopathy (R2 or R3a/s) or referable maculopathy (M1) based on the grading criteria defined by the United Kingdom National Screening Committee. Secondary and tertiary outcomes included the referable disease outcome stratified by the severity of DR at baseline, any progression in retinopathy grade, and incident diabetic maculopathy. Linkage data were obtained for 7360 participants (48% of those who were randomized in ASCEND). During their mean follow-up of 6.5 years, 548 participants (14.8%) had a referable disease event in the omega-3 FAs group, compared with 513 participants (13.9%) in the placebo group (rate ratio, 1.07; 95% confidence interval, 0.95–1.20; P = 0.29). There were no statistically significant between-group differences in the proportion of events for either of the secondary or tertiary outcomes. Representing the largest prospective test of its kind to date, these data exclude any clinically meaningful benefits of 1 g daily omega-3 FAs on DR.