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Efficacy of Marine ω-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults

2022; American Medical Association; Volume: 140; Issue: 7 Linguagem: Inglês

10.1001/jamaophthalmol.2022.1818

2168-6173

William G. Christen, Nancy R. Cook, JoAnn E. Manson, Julie E. Buring, I‐Min Lee, Vadim Bubes, Georgina Friedenberg, Rimma Dushkes, Douglas A. Smith, Debra A. Schaumberg, JoAnn M. Manson, Julie E. Buring, Nancy R. Cook, I‐Min Lee, William G. Christen, Shari S. Bassuk, Samia Mora, Heike Gibson, David Gordon, Trisha Copeland, Denise D’Agostino, Georgina Friedenberg, Clair Ridge, Vadim Bubes, Edward L. Giovannucci, Walter C. Willett, John A. Baron, Michael F. Holick, Bruce W. Hollis, Christine M. Albert, Diane R. Gold, Meryl S. LeBoff, Olivia I. Okereke, Aruna D. Pradhan, Howard D. Sesso, Wendy Chen, Paulette D. Chandler, J. Michael Gaziano, Olga Demler, Kathryn M. Rexrode, Karen H. Costenbader, John P. Forman, Erik K. Alexander, Sonia Friedman, Jeffrey N. Katz, Shumin Zhang, Jennifer Lin, Joseph Walter, Julie Duszlak, Kate Kalan, Jean MacFadyen, Natalya Gomelskaya, David W. Bates, Ara Sarkissian, Mary Breen, Yeulolani Andrade, Manickavasagar Vinayagamoorthy, Chunying Li, Eun‐Jung Kim, Franco Giulianini, Gregory Kotler, Marty Van Denburgh, Rimma Dushkes, Yanyan Liu, Eduardo Pereira, Lisa Fields Johnson, George Menjin, Lucy Liu, Lauren Girard, Scott L. Zeller, Naomi O. Riches, Katelyn Hasson, Ellen Bhang, Maria Revilla, Elena McCarthy, Alex Moran, Kristen Halse, L. Arsenault, Philomena Quinn, Sancia Grimes, Ivan Fitchorov, Kurt Schwerin, Shamikhah Curry, Annie Murray, Angela Zhang, Diana Walron-Williams, Alison Weinberg, Chris Pfeffer, Margaret Haubourg, Viviane Nguyen, Henry Ouellette, Rolando Rodríguez, Tony Montgomery, Keith Morse, Vincent Guzman, Megan A. Perry, Sandra Weekes, Doug Smith, Allison Clar, Sara R. Curran, Yaneve N. Fonge, David Brynn Hibbert, Louisa Paine, Kelly Royce, Courtney Splaine, Jennifer A. McMahon, David Eldridge, Laura C. Hand, Kay Inandan, Meghan RieuWerden, Harriet Samuelson, Andrea Hrbek, Megan Mele, Eileen Bowes, Mary Anne Ryan, Carlos A. Camargo, Jacqueline S. Danik, Ravi Thadhani, Thomas J. Wang, Raj C. Shah, Michelle A. Albert,

Seaweed-derived Bioactive Compounds

Importance Results of several small randomized clinical trials have suggested that supplements of marine ω-3 fatty acids may be beneficial in treating signs and symptoms of dry eye disease (DED). However, randomized clinical trial data to examine whether ω-3 fatty acid supplements can prevent DED are lacking. Objective To evaluate whether long-term daily supplementation with marine ω-3 fatty acids prevents the development of DED. Design, Setting, and Participants This was a prespecified ancillary study of the Vitamin D and Omega-3 Trial (VITAL), a nationwide randomized double-blind placebo-controlled 2 × 2 factorial trial of vitamin D and marine ω-3 fatty acids in the primary prevention of cancer and cardiovascular disease. Participants in this ancillary study were 23 523 US adults (men 50 years and older and women 55 years and older) who at study entry were free of a previous diagnosis of DED and were not experiencing severe dry eye symptoms. Participants were enrolled from November 2011 to March 2014, and treatment and follow-up ended on December 31, 2017. Data were analyzed from January 2020 to August 2021. Interventions Marine ω-3 fatty acids, 1 g per day. Main Outcomes and Measures The primary end point was incident clinically diagnosed DED confirmed by review of the medical records. The secondary end point was a composite of all confirmed incident clinically diagnosed DED cases plus all incident reports of severe DED symptoms. Results The mean (SD) age of the 23 523 participants included in the analysis was 67.0 (7.0) years, and 11 349 participants (48.3%) were women. The cohort included 4610 participants (20.0%) who self-identified as Black, 16 481 (71.6%) who self-identified as non-Hispanic White, and 1927 (8.4%) of other racial or ethnic groups or who declined to respond, consolidated owing to small numbers, including American Indian or Alaska Native, Asian, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander. During a median (range) 5.3 (3.8-6.1) years of treatment and follow-up, 472 of 23 523 participants (2.0%) experienced a medical record–confirmed diagnosis of DED. There was no difference in diagnosed DED by randomized ω-3 fatty acid assignment (232 of 11 757 participants [2.0%] with end points in the treated group vs 240 of 11 766 [2.0%] with end points in the placebo group; hazard ratio, 0.97; 95% CI, 0.81-1.16). Similarly, there was no difference between groups for the secondary end point of diagnosed DED plus incident severe DED symptoms (1044 participants [8.9%] with end points in the treated group vs 1074 [9.1%] with end points in the placebo group; hazard ratio, 0.97; 95% CI, 0.89-1.06). Conclusions and Relevance In this randomized clinical trial, long-term supplementation with 1 g per day of marine ω-3 fatty acids for a median (range) of 5.3 (3.8-6.1) years did not reduce the incidence of diagnosed DED or a combined end point of diagnosed DED or incident severe DED symptoms. These results do not support recommending marine ω-3 fatty acid supplementation to reduce the incidence of DED. Trial Registration ClinicalTrials.gov Identifier:NCT01880463