Synthetic EPA drug recommended to FDA for Cardio (Omega-3 is 8 X better) – Nov 2019

 Download the FDA Meeting agenda from VitaminDWiki

 Download the Study PDF from VitaminDWiki
Synthetic EPA (Vascepa) contains zero DHA
2 grams twice a day for 5 years had frequent side effects of joint pain

RESULTS Clipped from PDF
“A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001);…”

Reduction of Cardiovascular events

• 1.25 X reduction of risk with $380/month Synthetic EPA
• 10 X reduction of risk when Omega-3 index is > 6
• Thus a good level of Omega-3 provides 8 X the benefit of synthetic EPA

Note

• No direct comparison of EPA+DHA (Omega-3) with Synthetic EPA
• The FDA only requires that a drug be safe and better than a placebo
  • but not better than existing treatment or supplement
• FDA gets more than 45% of its annual budget from Industry fees( Big Pharma)
• Much more amount of money to be gained at many levels by prescribing a drug than by using a supplement
• FDA now allows specific Omega-3 health claims – July 2019

Huge number of Conflicts of Interest reported in the PDF

Dr. Bhatt reports receiving grant support from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis, The Medicines Company, Roche, Pfizer, Forest Laboratories/AstraZeneca, Ischemix, Amgen, Lilly, Chiesi, Ironwood, Abbott, Regeneron, PhaseBio, Idorsia, and Synaptic, fees for serving on CME steering committees from WebMD, advisory board fees from Elsevier, fees for serving on the board of directors from TobeSoft, fees for serving on an executive steering committee (with payments from Baim Institute Clinical Research) and for editorial support service from Boehringer Ingelheim, and fees for serving on the operations committee, on the publications committee, on a steering committee (with payments from Population Health Research Institute), and as the USA co–national leader from Bayer, unfunded research collaborations with FlowCo, Novo Nordisk, Plx Pharma, Takeda, and Merck, and serving on advisory boards for Medscape Cardiology, Regado Biosciences, and Cardax and as site co-investigator for St. Jude Medical (now Abbott), Biotronik, Boston Scientific, and Svelte;
Dr. Steg, receiving grant support and fees for serving on a steering committee from Bayer/Janssen, grant support and lecture fees from Merck, grant support, fees for serving as co-chair of the ODYSSEY outcomes trial and as co-chair of the SCORED trial, consulting fees, and lecture fees from Sanofi, consulting fees and lecture fees from Amgen, consulting fees, lecture fees, and fees for serving on an event committee from Bristol-Myers Squibb, fees for serving on an executive steering committee from Boehringer Ingelheim, fees for serving on an event committee from Pfizer, consulting fees and fees for serving on an executive steering committee from Novartis, consulting fees from Regeneron and Lilly, consulting fees and fees for serving as co-chair of the THEMIS trial from AstraZeneca, and grant support and fees for serving as chair of the data and safety monitoring committee for the ATPCI trial and as chair of the CLARIFY registry from Servier;
Dr. Brinton, receiving lecture fees from Boehringer, Janssen, Kaneka, and Novo Nordisk, consulting fees and lecture fees from Amarin, Amgen, AstraZeneca, Akcea, Kastle, Kowa, Merck, Sanofi, and Regeneron, and consulting fees from Arisaph, Denka-Seiken, Esperion, Medicure, Precision Biosciences, and PTS Diagnostics; Dr. Miller, receiving consulting fees from Amarin and Akcea; Dr. Jacobson, receiving consulting fees from AstraZeneca, Amgen, Novartis, Esperion, and Regeneron/Sanofi;
Dr. Ketchum, Mr. Doyle, Dr. Juliano, Dr. Jiao, and Dr. Granowitz, being employed by and being a stock shareholder of Amarin Pharma;
Dr. Tardif, receiving grant support from AstraZeneca, Esperion, and Ionis, grant support and consulting fees from DalCor, grant support and fees for serving as co-chairman of an executive committee from Pfizer, grant support and fees for serving on an executive committee from Sanofi, and grant support and consulting fees from Servier and holding a minor equity interest in DalCor and a patent (U.S. 9,909,178 B2) on Dalcetrapib for Therapeutic Use; and
Dr. Ballantyne, receiving consulting fees from AstraZeneca, Eli Lilly, Matinas BioPharma, Merck, Boehringer Ingelheim, Novo Nordisk, Denka Seiken, and Gilead and grant support (paid to her institution) and consulting fees from Amarin, Amgen, Esperion, Novartis, Regeneron, Sanofi-Synthelabo, and Akcea

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Vitamin D and Omega-3 category in VitaminDWiki starts with

394 Omega-3 items in category Omega-3 helps with: Autism (8 studies), Depression (29 studies), Cardiovascular (34 studies), Cognition (49 studies), Pregnancy (40 studies), Infant (32 studies), Obesity (13 studies), Mortality (7 studies), Breast Cancer (5 studies), Smoking, Sleep, Stroke, Longevity, Trauma (12 studies), Inflammation (18 studies), Multiple Sclerosis (9 studies), VIRUS (12 studies), etc
CIlck here for details

Omega-3 and Cardiovascular (items in both categories)