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Umm...pot calling the kettle black?
Yeah, like Norway, Sweden, Iceland, Finland. So sad!
The study used Lovaza.
I found this interesting:
"Remarkably, 11 of the 14 serious musculoskeletal events in the control group were total knee or hip replacements attributed to progressive pain and/or arthritis whereas there was only 1 in the omega-3 ethyl-ester group. This was an unexpected finding, which may be a consequence of more-limited symptoms and/or decreased progression of arthritis. Joint replacement is an expensive procedure; therefore, further studies should examine the effect of high-dose omega-3 ethyl-ester on joint symptoms given that prevention of joint replacement could be a huge cost-savings to the healthcare system."
That's good to hear.
The challenge will be getting providers and authorization entities to agree generic Lovaza is not equivalent to Vascepa IMO.
Yeah, my folks went from struggling poor to finally having some financial peace of mind but not for too long. Years of living on the edge takes a toll. I compiled my lipid history to see what diet and lifestyle changes might be doing, along with my Amarin investment history. I don’t take any meds.
July 2000
Standard American Diet
C---------------225
HDL-----------41
LDL-C--------159
T---------------123
May 2007
Standard American Diet
Started Running ~2004, No Prior Athletics
C----------------208
HDL------------53
LDL------------120
Ratio----------3.9
T----------------174
December , 2007
Opened Trading Account (Great Timing!)
April 1, 2013
Retired, Age 62
May, 2013
Long Amarin 5,000 @ $7.00 pps (Great Timing, Again!!)
November 2013
Gluten Free as of 2010
Dr. Mark Hyman Dietary Changes Starting 2012
Running, ~3.5 miles, 0-4 x/wk
C-------------------185
HDL---------------56
LDL---------------105
Ratio-------------3.3
Non HDL-C-----129
VLDL-------------24
T-------------------122
February 2016
2 Months on 4 g/d OmegaVia EPA500
Significant Anti-Inflammatory Diet Progress
Running, ~3.5 miles, 0-4 x/wk
C-------------------214
HDL---------------77
LDL---------------119
Ratio-------------2.8
Non HDL-C----137
VLDL------------18
T-------------------90
HsCRP----------0.83
January , 2017
Started Yoga
January 2018
2 Years on 4 g/d OmegaVia EPA500
Largely Anti-Inflammatory Diet: Few Simple Carbs,
Minimal Sugar, No Omega 6, No Processed Food,
"Food as Pharmacy" Principles.
Running, ~3.5 miles, 0-4 x/wk
~4 hrs/wk Yoga
Long Amarin, 66,000 @ $1.73 pps
C-------------------221
HDL---------------88
LDL---------------117
Ratio-------------2.5
Non HDL-C----133
VLDL-------------16
T-------------------78
Added 1,000 shares since January.
Another segue to nowhere. But if you must... My dad was on the boat to the Philippine’s when WW II ended. He would have been on the invasion. He died from his third heart attack at 67. No one was watching. Twenty below zero day. He was loading wheat from a bin to the truck with a motorized auger. Mom went out to check when he didn’t come in for lunch. There was a pile of grain spilled over on the ground. Neighbors came as quick as they could and dug out his body. Hard to understand mom when she called me from 3 states away. She lived alone at the farm after that. Five years later she had a brain aneurism and spent the next 15 years in a nursing home. Just turned 67 myself. So I too have an intense interest in cardiovascular and vascular diseases. Everybody has a story.
"IMHO , this board is way to hung up on JELIS."
Just like Jim, Kiwi, you're the only one in step. Proud of you!
----------------------
"Did you see my little Jimmy marching with the soldiers up the avenue?
There was Jimmy just as stiff as starch like his Daddy on the seventeenth of March.
Did you notice all the lovely ladies casting their eyes on him?
Away he went to live in a tent over in France with his regiment
Were you there, and tell me, did you notice?
They were all out of step but Jim."
From: "They were all out of Step but Jim"
I've read the JELIS paper a few times too. I read 1.8 gr. EPA. You've made two posts now stating 1 gr. EPA. Someone corrected you after your first post. Could you please concede 1.8 gr EPA or provide a reference showing it as 1.8 gr EPA?
http://epadruginitiative.com/files/JELIS_Full_Study_2007.pdf
Thanks.
My history with Amarin is similar except I started May 2013 and had 5,000 shares @ $7 prior to Adcom. Can't remember how I even stumbled across it. Anyway, I continued to follow it and kept learning. Sitting on 67,000 shares @ $1.80 now. Been taking 4 gr of EPA500 the last 2 years. Personal interest in CVD and chronic diseases. Same age (67) as father when he died of 3rd heart attack. Mom spent 15 years in a nursing home due to a brain aneurysm. Brother has T2DM. Younger sister in late stage early onset Alzheimer's. First cousin has Scleroderma, now doing better following kidney transplant. Likely sell 5,000 shares on run up if there is one and hold the rest. Science seems sound, trial is well designed, and the company is running the business in a straightforward, conservative, competent manner. If REDUCE-IT fails, life doesn't change much other than some dreams. Transformational if it succeeds. No whining. I take full responsibility for my losses and owe much to the contributors on this board if I win.
From:
Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial.
Deepak L. Bhatt Ph. Gabriel Steg Eliot A. Brinton Terry A. Jacobson Michael Miller Jean-Claude Tardif Steven B. Ketchum Ralph T. Doyle Jr Sabina A. Murphy Paresh N. Soni Rene A. Braeckman Rebecca A. Juliano Christie M. Ballantyne on behalf of the REDUCE-IT Investigators.
March, 15, 2017.
"The sample-size calculation was based on a hazard ratio assumption of 0.85. Therefore, 1612 events would be required to have approximately 90% power with a 1-sided a-level of 2.5% and with 2 interim analyses. This results in a total target sample size of 7990 patients. Approximately 70% of randomized patients were to be in CV risk stratum 1 (established CVD) and approximately 30% of randomized patients were to be in CV risk stratum 2 (high-risk primary prevention defined by diabetes mellitus and other risk factors). Randomization was stratified by CV risk strata, ezetimibe use, and by geographical region."
https://onlinelibrary.wiley.com/doi/full/10.1002/clc.22692
Get a Mac.
May have been as I had bookmarked it. Coworker died from this very disease a couple years ago. Below is a 2003 study that showed reduction of sun exposure cancer markers with 4 g/d EPA. Cancer treatment/prevention using EPA seems plausible from what I've seen.
https://academic.oup.com/carcin/article/24/5/919/2390522
If I could make a friendly suggestion, substantiate your assertions with facts & data. Also, get back to the uninformed person who told you about brain bleeding with the same advice.
http://www.clinicalnutritionjournal.com/article/S0261-5614(17)30118-8/pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5464992/pdf/nihms860790.pdf
STABILITY did show some benefit for secondary endpoints, perhaps due to Lp-PLA2 reduction. In their view, because statins also reduce Lp-PLA2, the incremental effect of additional reduction due to Darapladib may have been lessened.
Regardless, based on various literature, the fact that Vascepa lowers Lp-PLA2 seems like a good thing.
http://www.filipinoreporter.us/editorials/potpourri/3427-plac-test-can-predict-heart-attack-risk-in-individuals-with-no-symptoms.html
http://www.atherosclerosis-journal.com/article/S0021-9150(06)00701-5/pdf
http://www.atherosclerosis-journal.com/article/S0021-9150(14)00102-6/pdf
http://www.nejm.org/doi/full/10.1056/NEJMoa1315878
Thanks for trying to sharpen the dull knives on the board.
My history:
July 2000
Standard American Diet
C---------------225
HDL-----------41
LDL-C--------159
T---------------123
May 2007
Standard American Diet
Started Running ~2004, No Prior Athletics
C----------------208
HDL------------53
LDL------------120
Ratio----------3.9
T----------------174
December , 2007
Opened Trading Account (Great Timing!)
April 1, 2013
Retired, Age 62
May, 2013
Long Amarin 5,000 @ $7.00 pps (Great Timing, Again!!)
November 2013
Gluten Free as of 2010
Dr. Mark Hyman Dietary Changes Starting 2012
Running, ~3.5 miles, 0-4 x/wk
C-------------------185
HDL---------------56
LDL---------------105
Ratio-------------3.3
Non HDL-C-----129
VLDL-------------24
T-------------------122
February 2016
2 Months on 4 g/d OmegaVia EPA500
Significant Anti-Inflammatory Diet Progress
Running, ~3.5 miles, 0-4 x/wk
C-------------------214
HDL---------------77
LDL---------------119
Ratio-------------2.8
Non HDL-C----137
VLDL------------18
T-------------------90
HsCRP----------0.83
January , 2017
Started Yoga
January 2018
2 Years on 4 g/d OmegaVia EPA500
Largely Anti-Inflammatory Diet: Few Simple Carbs,
Minimal Sugar, No Omega 6, No Processed Food,
"Food as Pharmacy" Principles.
Running, ~3.5 miles, 0-4 x/wk
~4 hrs/wk Yoga
Long Amarin, 66,000 @ $1.73 pps
C-------------------221
HDL---------------88
LDL---------------117
Ratio-------------2.5
Non HDL-C----133
VLDL-------------16
T-------------------78
You may need additional items included in the blood test, e.g., VLDL, LDL-C particle size and has-CRP to get a better fix on things. Lp-PLA2 wouldn't hurt either.
My 64 year old sister, 3 years younger than me, is in the late stages of early onset Alzheimer's. Lived alone, never married. Symptoms, not recognized by anyone for a long time, began maybe 10 years ago. Terrible disease! I don't seem to have symptoms near as I can tell, but paranoia runs amok.
Needless to say, I'm learning everything I can and pursuing anti inflammatory lifestyle choices to reduce the risk as much as possible. Simple carbs (potatoes, bread-there is no such thing as a healthy whole grain, rice, etc.), sugar (except naturally occurring in fruits, etc.) are kept to a minimum. No omega 6 vegetable oils in the house, no processed food products. Aerobic exercise is consistently associated with preventing Alzheimer's so I do that. Hearing loss is thought to correlate with Alzheimer's so I got hearing aids. In addition, I take 4 g/d OmegaVia EPA500 as well as turmeric, an anti inflammatory supplement.
I agree with BB that treatments to reverse symptoms once they appear seems unlikely anytime soon. Meanwhile, I'm doing what I can as a familial at-risk person to prevent Alzheimer's and that includes taking high dose EPA supplementation. If BRAVE-EPA does show effectiveness, I'll be camped outside my Dr.'s door until I get a prescription for Vascepa. I'm long Amarin since May 2013.
More inference that Vascepa could be beneficial for preventing Alzheimer's Disease. The researchers quoted in this NPR article hypothesize that the amyloid plaques may be a response to infection or other invaders.
"One possibility is that it's overreacting to viruses and bacteria that get into the brain. Or, the system could be getting confused and attacking healthy cells — a lot like what happens in diseases like lupus or multiple sclerosis."
https://www.npr.org/sections/health-shots/2018/02/18/580475245/scientists-explore-ties-between-alzheimers-and-brains-ancient-immune-system?sc=ipad&f=1001
Have you watched "The Widowmaker" documentary? Didn't know what it was nor the fascinating, controversial history behind the CCS until I saw it. Stent industry is not a fan of CCS. I came away with a jaundiced view of Dr. Steven E. Nissen, similar to this comment at the end of this review:
"René O. Oliveira, a Texas legislator, heart patient and scan advocate, says, “He’s an idiot."
https://www.nytimes.com/2015/02/27/movies/review-the-widowmaker-a-heart-care-documentary.html
Here's a couple studies on omega 3/fish oil wrt bleeding. Does not seem to carry risk although none were EPA only. Been on 4 g/d OmegaVia EPA500 for ~2 years w/no problems. Colleague died from CRC liver metastasis a couple years ago so if were me I'd try to find a way to get 4 g/d.
https://www.ncbi.nlm.nih.gov/pubmed/28427779
http://www.americanjournalofsurgery.com/article/S0002-9610(16)30462-7/pdf
Zero patience. He posts all this complex TA. If he can't take time to get the simple stuff correct it diminishes credibility for everything else.
Pay attention and try to keep up.
4 capsules per day containing IPE (equivalent to 4 g EPA-ethyl ester [EE] daily) or 4 placebo capsules per day
https://clinicaltrials.gov/ct2/show/NCT03428477?term=vascepa&draw=3&rank=8
Effect of eicosapentaenoic acid, an omega-3 polyunsaturated fatty acid, on UVR-related cancer risk in humans. An assessment of early genotoxic markers.
Lesley E.Rhodes1,2,6, Hassan Shahbakhti1,2, Richard M.Azurdia2, Ralf M.W.Moison3, Marie-Jose S.T.Steenwinkel4, Marie I.Homburg5, Michael P.Dean1,2, F.McArdle2, Gerard M.J.Beijersbergen van Henegouwen3, Bernd Epe5 and Arie A.Vink4
1Photobiology Unit, Dermatology Centre, University of Manchester, Manchester, UK, 2Department of Dermatology/Medicine, Royal Liverpool University Hospital and University of Liverpool, Liverpool, UK, 3Department of Medicinal Photochemistry, Leiden/Amsterdam Centre for Drug Research, Leiden University, The Netherlands, 4TNO Nutrition and Food Research, Zeist, The Netherlands and 5University of Mainz, Mainz, Germany
To whom correspondence should be addressed Email: lesley.e.rhodes@man.ac.uk
https://academic.oup.com/carcin/article/24/5/919/2390522
__________________________
In this study (which I posted previously), p53 expression was reduced in the skin of people exposed to UVR who had taken 4 g/d EPA vs. people who took a placebo.
TP53 is classified as a tumor suppressor gene. It encodes the tumor protein p53, described as guardian of the genome because of its role in conserving stability by preventing genome mutation. Below are links with p53 information:
https://www.nature.com/scitable/topicpage/p53-the-most-frequently-altered-gene-in-14192717
https://www.quantamagazine.org/a-zombie-gene-protects-elephants-from-cancer-20171107/
https://www.washingtonpost.com/national/health-science/why-do-elephants-rarely-get-cancer/2015/10/12/72a1849a-6df0-11e5-b31c-d80d62b53e28_story.html?utm_term=.20fcc0dc49fb
The researchers concluded that less P53 was expressed because there was less damage that needed repair as a result of EPA treatment. They acknowledged the EPA could have somehow impeded P53 expression but reduction of sunburn response relative to the placebo reinforces their conclusion that EPA reduced UVR damage.
This result suggests, at a minimum, plausibility for EPA treatment as a cancer therapy or prevention strategy. If EPA protects one organ from insults, might it not protect others?
As noted by CBB, the study is 15 years old. So why didn't the vaunted BP seize on this and run outcome trials for various cancers? Well, BP's business case is based on selling products to which they have competitive barriers such as proprietary rights, and in their (nearly) infinite wisdom, likely moved on (if they saw it at all) because obviously (to them) a common molecule found in nature can't be patented. Guess they were wrong since apparently they didn't consider the idea of patenting a concentrated form of the molecule.
While Amarin has EPA patents for a number of purposes, I don't know if cancer treatment is one of them. Meanwhile, I surmise R-I data will be exhaustively analyzed, and reduced incidence of cancer is a plausible finding. If so, Amarin should stand to benefit.
Thanks.
Fintel shows 16th of 113 and 1.2% increase as of 2/13/2018 SC 13G/A. ~$12.4G portfolio value.
https://fintel.io/i/baker-bros-advisors-lp
Appears Amarin is 14th out of 119 total holdings in ~$10B Baker Brothers hedge fund. Why is that?
https://www.nasdaq.com/quotes/institutional-portfolio/baker-bros-advisors-lp-596248
But you know best I guess.
The % of people who alter their lifestyle choices as a result of a life altering event is roughly equal to number of people whose political positions are changed by a Facebook post. Especially when taking the magic statin pill.
Lot of long words, but yes.
Abstract
Dietary omega-3 polyunsaturated fatty acids (?-3 PUFAs) protect against photocarcinogenesis in animals, but prospective human studies are scarce. The mechanism(s) underlying the photoprotection are uncertain, although ?-3 PUFAs may influence oxidative stress. We examined the effect of supplementation on a range of indicators of ultraviolet radiation (UVR)-induced DNA damage in humans, and assessed effect on basal and post-UVR oxidative status. In a double-blind randomized study, 42 healthy subjects took 4 g daily of purified ?-3 PUFA, eicosapentaenoic acid (EPA), or monounsaturated, oleic acid (OA), for 3 months. EPA was bioavailable; the skin content at 3 months showing an 8-fold rise from baseline, P < 0.01. No consistent pattern of alteration in basal and UVR-exposed skin content of the antioxidants glutathione, vitamins E and C or lipid peroxidation, was seen on supplementation. Sunburn sensitivity was reduced on EPA, the UVR-induced erythemal threshold rising from a mean of 36 (SD 10) mJ/cm 2 at baseline to 49 (16) mJ/cm 2 after supplementation, P < 0.01. Moreover, UVR-induced skin p53 expression, assessed immunohistochemically at 24 h post-UVR exposure, fell from a mean of 16 (SD 5) positive cells/100 epidermal cells at baseline to 8 (4) after EPA supplementation, P < 0.01. Peripheral blood lymphocytes (PBL) sampled on 3 successive days both pre- and post-supplementation, showed no change with respect to basal DNA single-strand breaks or oxidative base modification (8-oxo-dG). However, when susceptibility of PBL to ex vivo UVR was examined using the comet assay, this revealed a reduction in tail moment from 84.4 (SD 3.4) at baseline to 69.4 (3.1) after EPA, P = 0.03. No significant changes were seen in any of the above parameters following OA supplementation. Reduction in this range of early markers, i.e. sunburn, UVR-induced p53 in skin and strand breaks in PBL, indicate protection by dietary EPA against acute UVR-induced genotoxicity; longer-term supplementation might reduce skin cancer in humans.
This is the third time I've posted this study in the past few days.
Effect of eicosapentaenoic acid, an omega-3 polyunsaturated fatty acid, on UVR-related cancer risk in humans. An assessment of early genotoxic marker
https://academic.oup.com/carcin/article/24/5/919/2390522
Sorry. Try this one.
https://academic.oup.com/carcin/article/24/5/919/2390522
Here's one, published in 2003.
Effect of eicosapentaenoic acid, an omega-3 polyunsaturated fatty acid, on UVR-related cancer risk in humans. An assessment of early genotoxic markers
https://watermark.silverchair.com/bgg038.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAaowggGmBgkqhkiG9w0BBwagggGXMIIBkwIBADCCAYwGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMR16MCOlSMffxMGfDAgEQgIIBXcN_m9vLTQ25fxD-FlK6-2ucL6HD8LEY3WTu1oMTfWteGhuaiKy08PJsElk0sDjNc_CKrxuBVyeWMegTVdUQb8UKGBf33H9S1GGFlsSae2kh9_WB4Hgm3jaFF3_oxjrIGHnvj4jDzXLLjmVCXf45Us-RLnirsmcs4iiZDwHS253_JcEBqm0QYEHpH9Axlj-KHkJCh3jexgmvwOTbgEEl-ydtvCXQB2o8iOiNIWlPZWY_r_iJP2uBuefuiuBDE62XeBSgcOQNwpep_1A40qPifKCJNCb1Ie1r4ghfbT4jnhcl2bnsTpxjDdk247-W867BYCH7JS2llr7rEDqztQicwmyJOW020gbRgLS7uhyJCmx1qWaJlXHpZ4BwH2dAh25jalgOIuWHBEsl40HIecSUve4yMCFyMqEEhjxbN9Hyp-G4x2cTC3Z96DVTZN_g-WsHTF_5kVkyj9AsdwSFf2c
Apparently JL's caustic characterizations of BP as innovation-free bastions of greedy groupthink have gone clean over your head. BP couldn't fight it's way through a ditch full of popcorn to an unburied treasure chest marked by a sign. You saw the study I posted a couple days ago about a 4 g/d EPA study on sunburn published in 2003 right? It showed reduction of p53 expression in the skin among other things! You should look up p53 expression sometime. Big companies often defend the status quo, sometimes to the death.
Remember the high priests of Big Computer in their air conditioned glass walled sanctuaries? DEC is gone and IBM tries to find its way. They scoffed at PC's. Did Big Oil end our dependency on imports and OPEC? No, that was done by a few wildcatters in ND and TX if you recall. My dad told of the farmer who got the first rubber tired tractor in our neighborhood. "Won't last a day!" his peers scoffed. Well, we all know what happened to Big Iron Tire. Then, of course we all got to see Big Rocket humiliated this week with the launch of the Falcon Heavy. That with a poke in the eye to Big Auto and Big Spacesuit with its payload. Eventually someone is going to realize Big Food is responsible for our big asses. Wonder how that's going to turn out.
Interesting study that showed 4g/day EPA decreased sunburn sensitivity, p53 expression, less DNA damage. Wonder why they chose EPA at this dosage? 2003 study!
Abstract
Dietary omega-3 polyunsaturated fatty acids (?-3 PUFAs) protect against photocarcinogenesis in animals, but prospective human studies are scarce. The mechanism(s) underlying the photoprotection are uncertain, although ?-3 PUFAs may influence oxidative stress. We examined the effect of supplementation on a range of indicators of ultraviolet radiation (UVR)-induced DNA damage in humans, and assessed effect on basal and post-UVR oxidative status. In a double-blind randomized study, 42 healthy subjects took 4 g daily of purified ?-3 PUFA, eicosapentaenoic acid (EPA), or monounsaturated, oleic acid (OA), for 3 months. EPA was bioavailable; the skin content at 3 months showing an 8-fold rise from baseline, P < 0.01. No consistent pattern of alteration in basal and UVR-exposed skin content of the antioxidants glutathione, vitamins E and C or lipid peroxidation, was seen on supplementation. Sunburn sensitivity was reduced on EPA, the UVR-induced erythemal threshold rising from a mean of 36 (SD 10) mJ/cm 2 at baseline to 49 (16) mJ/cm 2 after supplementation, P < 0.01. Moreover, UVR-induced skin p53 expression, assessed immunohistochemically at 24 h post-UVR exposure, fell from a mean of 16 (SD 5) positive cells/100 epidermal cells at baseline to 8 (4) after EPA supplementation, P < 0.01. Peripheral blood lymphocytes (PBL) sampled on 3 successive days both pre- and post-supplementation, showed no change with respect to basal DNA single-strand breaks or oxidative base modification (8-oxo-dG). However, when susceptibility of PBL to ex vivo UVR was examined using the comet assay, this revealed a reduction in tail moment from 84.4 (SD 3.4) at baseline to 69.4 (3.1) after EPA, P = 0.03. No significant changes were seen in any of the above parameters following OA supplementation. Reduction in this range of early markers, i.e. sunburn, UVR-induced p53 in skin and strand breaks in PBL, indicate protection by dietary EPA against acute UVR-induced genotoxicity; longer-term supplementation might reduce skin cancer in humans.
https://academic.oup.com/carcin/article/24/5/919/2390522
WSJ article on 1/20/2018 by Jonathan D. Quick says less than 30% effective this year.
I agree. As JL said, DS is little threat to RI if it is successful, but something must be driving Amarin's sense of urgency. My thought is their 10 off-label promotion opportunities and other planned pursuits for Vascepa. DS would likely be a threat to those and if Amarin doesn't object now, it becomes tacit acceptance in my opinion. Timing could mean Amarin has go ahead for an off-label indication as soon as RI is complete.
1) The two studies you referenced stated treatment with 1.5 and/or 3 grams/day omega 3 fatty acids, not specifically EPA. As such, we can be pretty sure a mix of EPA and DHA was used based on typical reporting protocol for omega 3 studies.
2) Amarin MARINE study showed 36% reduction in hsCRP, 4 grams/day Vascepa.
3) Amarin ANCHOR Study showed 22% reduction in hsCRP, 4 grams/day Vascepa.
Please post scientific based substantiation of your assertion that EPA does not reduce hsCRP or kindly issue a retraction.
JL
I organized copies of the material below in a 3-ring binder, including numbered index tabs, and dropped it off at the clinic several days before my appointment. My Dr. hadn't read it, but he said he would and I'm hopeful that our conversation about Vascepa and REDUCE-IT piqued his interest enough to follow through. This was the first time he had met me, and he seemed less defensive by the time the appointment ended.
I didn't ask for a prescription for Vascepa because that seemed unfair given we just met. He did not challenge my taking 4 gr./day of EPA500 based on that it wasn't doing any harm and could be a benefit. This all seemed to be a new area for him.
Doctors are in a conundrum in my opinion. My preference would be for my Dr. to be teacher and coach and help me stay out of his office but I may be in the minority, and in any event, I don't know that our health care system incentivizes that behavior. Some patients want to be told what to do, some think pills fix everything so that's what they want, some are afraid to challenge the Dr., some consider it an affront to be encouraged to research on their own ("that's what I'm paying you for"), some are lazy, some are so overwhelmed with life that just getting to tomorrow takes all they have, some are hypochondriacs and see looming disaster with the slightest ache. It does not appear that recommendations for lifestyle changes are warmly received or acted upon generally.
____________________________________________
Table of Contents
1. Personal Story
2. A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT
3. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial
4. Prescription omega-3 fatty acid products containing highly purified eicosapentaenoic acid (EPA)
5. Eicosapentaenoic acid inhibits glucose-induced membrane cholesterol crystalline domain formation through a potent antioxidant mechanism
6. Icosapent Ethyl, a Pure Ethyl Ester of Eicosapentaenoic Acid: Effects on Circulating Markers of Inflammation from the MARINE and ANCHOR Studies
7. Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid (BRAVE-EPA)
8. UW, VA study looks at fish oil to prevent Alzheimer's disease, Wisconsin State Journal
9. Risk of post-procedural bleeding in children on intravenous fish oil
10. Fish oil LC-PUFAs do not affect blood coagulation parameters and bleeding manifestations: Analysis of 8 clinical studies with selected patient groups on omega-3-enriched medical nutrition
11. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised openlabel, blinded endpoint analysis
Personal Story
Vascepa, a prescription drug, is a highly purified form (eicosapent ethyl) of eicosapenaenoic acid (EPA) produced and sold by Amarin. It is FDA approved for treatment of triglycerides over 500. Unlike its competitor Lovaza and its generic counterpart, Vascepa does not raise LDL and does not have an afib indication. Vascepa's safety profile is that of a placebo.
Amarin competed the ANCHOR Study, a phase 3 trial, in 2011 and met the endpoint for treatment of triglycerides from 200 to 500 on patients also taking a statin. Despite meeting the endpoint and satisfying the FDA Supplemental Protocol Assessment (SPA), the FDA nevertheless denied approval for the new indication because it has not been proven that lowering triglycerides improves cardiovascular disease (CVD) outcomes.
Amarin is conducting a CVD outcomes trial called REDUCE-IT. Patients on statins take either 4 grams of Vascepa per day or a placebo. The trial is expected to reach its specified number of events in early 2018 and report results later in the year.
Meanwhile, Amarin won a lawsuit with the FDA that gives them first amendment rights for off-label promotion of Vascepa for treatment of triglycerides between 200 and 500 using truthful and non-misleading information.
I learned about Vascepa in 2013 when searching for investment opportunities. Since then I have extensively studied omega 3 science, CVD treatment, and lifestyles associated with prevention of inflammation based disease processes. EPA is a powerful anti-inflammatory polyunsaturated fatty acid (PUFA) and studies suggest pleiotropic effects. Secondary endpoints in REDUCE-IT will provide data to assess some of these. Amarin's MARINE and ANCHOR trials both lowered inflammatory markers.
Because of family history my wife and I desire to take Vascepa as a preventive measure; however, neither of us qualify for a prescription, either on or off-label. As such, we have taken 4 grams per day of a dietary supplement EPA, EPA500 produced by OmegaVia for the last 2 years.
The older of my 2 sisters has early onset Alzheimer's. She is 64, about 3 years younger than me and living in a memory care unit. The VA Hospital in Madison is currently conducting an Alzheimer's prevention study, BRAVE-EPA, on people with a family history of Alzheimer's. The treatment arm is receiving 4 grams per day of Vascepa.
______________________________________________