Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation: A Randomized Clinical Trial
Albert CM, Cook NR, Pester J, Moorthy MV, Ridge C, Danik JS, Gencer B, Siddiqi HK, Ng C, Gibson H, Mora S, Buring JE, Manson JE
JAMA · 109 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Center for Complementary and Integrative Health
- Gobierno
- NHLBI NIH HHS
- Gobierno
- NCI NIH HHS
- Gobierno
- NCCIH NIH HHS
- Gobierno
- NIDDK NIH HHS
- Subvenciones
- National Cancer Institute (U01CA138962); National Heart, Lung, and Blood Institute (R01 HL134811); National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK112940); National Heart, Lung, and Blood Institute (T32HL007575); National Heart, Lung, and Blood Institute (R01 HL116690); National Cancer Institute (R01CA138962); National Heart, Lung, and Blood Institute (K24HL136852); National Center for Complementary and Integrative Health (R01AT011729)
Según 8 financiadores declarados.
Publicación
- Publicado
- 2021-03-16 · JAMA · vol. 325 · número 11 · pág. 1061
- Editorial
- American Medical Association
- Citado
- 131 citas · más que el 100% de estudios similares · 13.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 43 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · Atrial Fibrillation Management and Outcomes · Nutritional Studies and Diet
- Palabras clave
- atrial fibrillation, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid, vitamin D3, dietary supplementation, incident atrial fibrillation, older adults, cardiovascular risk factors, blood pressure, hypertriglyceridemia, triglycerides, HDL cholesterol, LDL cholesterol, triglyceride to HDL cholesterol ratio
- MeSH
- humans, atrial fibrillation, vitamin d deficiency, cholecalciferol, docosahexaenoic acids, eicosapentaenoic acid, vitamins, treatment failure, drug therapy, combination, double-blind method, dose-response relationship, drug, dietary supplements, aged, middle aged, female, male
13 autores
- Christine M. Albert🇺🇸 · autor de correspondenciaCedars-Sinai Medical Center; Brigham and Women's Hospital; Harvard University; Cedars-Sinai Smidt Heart Institute
- Nancy R. Cook🇺🇸Brigham and Women's Hospital; Harvard University
- Julie Pester🇺🇸Brigham and Women's Hospital; Harvard University
- M. Vinayaga Moorthy🇺🇸Brigham and Women's Hospital; Harvard University
- Claire Ridge🇺🇸Brigham and Women's Hospital; Harvard University
- Jacqueline Suk Danik🇺🇸Harvard University; Massachusetts General Hospital
- Bariş Gencer🇺🇸Brigham and Women's Hospital; Harvard University
- Hasan Khalid Siddiqi🇺🇸Brigham and Women's Hospital; Harvard University
- Chee Ng🇺🇸Harvard University; Massachusetts General Hospital
- Heike Luttmann‐Gibson🇺🇸Brigham and Women's Hospital; Harvard University
- Samia Mora🇺🇸Brigham and Women's Hospital; Harvard University
- Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University
- JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Atrial fibrillation (AF) is the most common heart rhythm disturbance, continues to increase in incidence, and results in significant morbidity and mortality. The marine omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D have been reported to have both benefits and risks with respect to incident AF, but large-scale, long-term randomized trial data are lacking.
Objective
To test the effects of long-term administration of marine omega-3 fatty acids and vitamin D on incident AF.
Design, setting, and participants
An ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.
Interventions
Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed).
Main outcomes and measures
The primary outcome was incident AF confirmed by medical record review.
Results
Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).
Conclusions and relevance
Among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.
Trial registration
ClinicalTrials.gov Identifiers: NCT02178410; NCT01169259.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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