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  • Amarin's Fish Oil: Looking Beyond Triglycerides 28 comments
    Apr 29, 2013 5:43 PM

    It's been approximately a year since my last article on Amarin (NASDAQ:AMRN). It's stock price ran up to a high of $16 at FDA approval and subsequently has been in a downtrend post approval over issues with NCE, lack of anticipated BuyOut/partnership deals, etc. I am not qualified to give an opinion about the effectiveness of Amarin Management or Vascepa Marketing Strategies of the company, but the health benefits of Amarin's fish oil has not changed. This article serves as an Amarin update from last year's article and some thoughts I have regarding Vascepa since.

    Amarin is currently FDA approved only for it's Marine trial indications: triglycerides above 500 mg/dL. Currently, approximately 4 Million Americans would be eligible for Vascepa.

    Recently Amarin announced the FDA's Acceptance of its sNDA application for Vascepa treatment of High Triglycerides between 200-499 mg/dL with Mixed Lipidemia. This is based on its successful Phase III Anchor Study data. An FDA approval of its Anchor Study sNDA expands this market to 40 million Americans who have triglycerides above 200 mg/dL. That is a tenfold increase of its current potential market share. PFUDA date for the Anchor trial data is in December 2013.

    (click to enlarge)

    GSK's Lovaza patent will expire soon. It's NCE exclusivity has already expired years ago without the "feared generic challenges" often discussed online. Lovaza brought in approximately One Billion Dollars in revenue last year. Since the launch of Vascepa in January, prescription growth rates have been steady. The speed of prescription growth for effective market penetration is under debate, but from my experience, the medical community is only beginning to learn about Vascepa.

    (click to enlarge)

    With just under 300 sales reps hired to knock on physician offices in the USA, one can imaging the speed (or lack thereof) of market penetration for Vascepa. Despite that, as of this writing, Vascepa is now Tier 2 on four national formularies (that's a good thing). Most national formularies provide a 3 months supply of medication at a time. Because of this protocol, I am assuming that the prescription data would only capture a Vascepa prescription written every 3 months rather than monthly.

    Amarin is taking out entire full page articles in JAMA to market Vascepa.

    (click to enlarge)

    The company is also conducting presentations for physicians. I've had the opportunity to attend Vascepa presentations to physicians and gauge their responses. (click to enlarge)

    These presentations are only authorized to stick with the FDA Approved Script: Vascepa for Triglycerides above 500 mg/dL. Quite frankly, if the issue is purely the fact that Vascepa lowers Triglycerides above 500 mg/dL, then I would respond with a big "yawn." There are already plenty of other products that lowers triglycerides: Niacin, fibrates, Bile Acid Sequestrants, lovaza, and let's not forget diet and exercise (which obviously isn't quite working with the growing obesity epidemic).

    Let's take a look at several Classes of Triglyceride lowering medications already on the market:

    Niacin: A recently large study presented at the American College of Cardiology (ACC) meeting this year did not bode well for niacin. The HPS2-THRIVE Study was published in March 2013. This landmark study of 25,673 patients showed that niacin did not reduce the risk of cardiovascular events compared with statins. The study design bothers me somewhat - patients with already "near perfect" LDL cholesterol levels were chosen for the study - but it's conclusion was statistically significant. Some prescription name brands of niacin include niaspan (NYSE:ABT).

    Fibrates: The Landmark ACCORD lipid trial involving 5,518 patients showed that fibrates do not reduce mortality but may reduce nonfatal coronary events in patients at risk for heart disease with the combination of low dose simvastatin and fenofibrate. The concern in clinical practice is that many times a "low dose statin" is not adequate for cholesterol control, and a "higher dose" statin with fibrates may cause adverse side effects including muscle injury. Physicians do not like to get phone calls from the pharmacy to warn them of potential interactions of between high dose statins and fibrate combinations. This presents a dilemma with using fibrates. Generic Gemfibrozil is available at most pharmacies for $4. Tricor is a brand name Fibrate. Trilipix is one FDA approved to be taken with statins.

    Bile Acid Sequestrants: BAS are not absorbed by the intestine and thus have no systemic drug-drug interactions, but may interfere with the absorption of some drugs. They are not often used as first line lipid lowering therapy due to their potential GI side effects but can be used to complement other cholesterol lowering therapies. Several products that come to mind include Welchol (OTCPK:DSKYF) and Questran (NYSE:BMY).

    Fish Oil: Prior to Vascepa, Lovaza was the only FDA approved prescription fish oil on the market. It is FDA approved for lowering very high triglycerides above 500 mg/dL, it also carries with it a warning of elevating LDL ("bad") cholesterol and more recently a warning of "cardiac arrthymia" side effects.

    Let's move on to Vascepa. It is highly purified EPA Fish Oil. This separates Vascepa from both Lovaza and the OTC Fish Oil products which contain a combination of both DHA and EPA Omega-3 products.

    As mentioned above, my interest in Vascepa is not because of it's ability to treat very high Triglycerides over 500 mg/dL. There are already products on the market FDA approved for this. What separates Vascepa from the pack will be explained next.

    Vascepa's studies have shown statistically significant decreases of cardiac risk factor biomarkers that have not received the "front and center" attention I believe it deserves: Vascepa lowers apolipoprotein C-III, apolipoprotein B, non-HDL-C, total cholesterol, and VLDL-C.

    Apolipoprotein C-III: In the MARINE trial the 4 gram dose of Vascepa reduces Apo C-III levels by 25% compared to placebo. It has been noted that the risk of coronary heart disease contributed by LDL cholesterol appeared to result, to a large extent, from LDL that contains apoC-III.

    Apolipoprotein B: This Lipid Marker is a more reliable indicator of cardiac risk than LDL Cholesterol alone.

    Non-HDL-C: This Lipid Marker is correlated highly with cardiovascular disease, again more so than the typical LDL cholesterol value.

    VLDL-C: A Study in China showed that cardiac disease risk was further amplified when elevated VLDL cholesterol was combined with elevated LDL cholesterol and/or the presence of major CVD risk factors.

    What's the significance of Vascepa's ability to lower these various Lipid Biomarkers? In my opinion the cardiovascular protection of reducing these lipid biomarkers is much larger than simply lowering triglycerides. When lipid biomarkers like these can be lowered we move from the arena of treatment of cardiac disease into primary prevention of cardiovascular disease.

    Understanding the significance of this data allows us to appreciate more fully the following study recently published:

    A study published in The Annals of Internal Medicine (April 2013) concludes that higher blood levels of omega-3 fatty acids (fish oil) is associated with a lower risk of premature death among older adults. This study correlated fish consumption with cardiovascular events. High EPA levels (primary ingredient of Vascepa) were strongly linked with lower risk of nonfatal heart attacks. Study participants with the highest levels of all three types of fatty acids (DHA, EPA, DPA) had a 27% lower risk of total mortality due to all causes. Of course it would be ideal if we all ate several servings of fish per week to obtain these benefits, but unfortunately our society has chosen several servings of hamburgers and pizzas per week instead. Some even eat chicken feet.

    Folks, we can not lower premature death significantly among older adults just by lowering their triglyceride levels alone. There is something more to Fish Oil than the FDA Approved triglyceride lowering effects.

    Let's go back to The Jelis Study published a few years ago. The significance of this study is that the product studied was EPA Fish Oil (similar to Vascepa).

    (click to enlarge)

    The Jelis Study was large: 18,645 patients. It evaluated only EPA fish oil's effectiveness (not DHA). In the Total Cohort graph, no triglyceride minimum numbers were required to be eligible to participate. Total cholesterol higher than 250 mg/dL was required for eligibility as well as having risk factors for heart disease. Patients were divided into 2 groups: One group on Statins and the other on Statins and EPA fish oil.

    After mean follow-up of 4.6 years, the primary endpoint of major coronary events, defined as sudden cardiac death, fatal or nonfatal myocardial infarction (heart attack), unstable angina pectoris (cardiac chest pain), and coronary artery bypass graft/percutaneous coronary intervention (CABG/PCI), was significantly reduced by 19% in the EPA fish oil group compared with the statin-only group.

    In a Sub Group analysis published in 2008, in patients who had both high triglycerides (above 150 mg/dL) and low HDL "good" cholesterol (less than 40 mg/dL), pure EPA treatment suppressed the risk of cardiac events by 53%.

    Again, take a "bird's eye view" of this story and realize that we cannot lower cardiac events by 53% simply by lowering triglyceride levels alone.

    If fish oil in general and Vascepa specifically was just about lowering triglycerides, we wouldn't be seeing these types of health benefits from simply triglyceride lowering. These are the benefits of lowering the various lipid biomarkers discussed above.

    From the Jelis study we can conclude that the ideal cardioprotective package would be a combination of a Statin-Vascepa Pill: the statin will focus on lowering Total cholesterol and LDL ("bad") cholesterol, while Vascepa addressing Triglycerides and other lipid biomarkers noted above. Both will lower hs-CRP levels (a marker for inflammation).

    Amarin understands this and have Patent '889 (Combo Statin-Vascepa) in the works. It's Fixed-Dose Combination Study with Vascepa and a Leading Statin is in progress. Results from this study are expected in the first half of 2013 (which means probably around June 2013). The REDUCE-IT Study is currently underway in an attempt to replicate the Jelis findings as well.


    The American Journal of Cardiovascular Drugs published February 2013 indicates that Vascepa significantly lowers circulating markers of inflammation from both the Marine and Anchor studies: Vascepa decreases levels of Ox-LDL, Lp-PLA(2), and hs-CRP levels.

    This confirms reports published in previous articles regarding fish oil's effect in lowering "inflammation."

    Oxidized (Ox)-LDL can modulate disease development and systemic inflammation associated with an enhanced risk of cardiovascular disease.

    hs-CRP levels have been associated with an increase risk for cardiovascular disease among other disease conditions that deserves a comprehensive discussion in the future.

    Lp-PLA(2) has emerged as a candidate marker of inflammation that may play a direct role in the formation of rupture-prone plaque. "Ruptured plaques" are unstable plaques in your arteries that break off and head downstream to cause heart attacks and strokes.

    Fish Oil and Other Inflammatory Diseases (Not Specific to Vascepa)

    Alzheimer Dementia: There is a growing number of reports indicating an association between alzheimer dementia and inflammation. This link was published in the journal Nature recently which will lead to new clinical trials to confirm this association. Both DHA and EPA Fish Oils have been evaluated with its role in brain function and memory showing positive clinical correlation. A review of past clinical studies have shown some mixed results, but of note is an article showing specifically EPA's effect on preventing memory loss. Unfortunately, Cochrane Summaries indicate that the available fish oil studies show no benefit for cognitive function with omega-3 PUFA supplementation but acknowledge that longer studies are required to enable researchers to identify changes in cognitive function. The verdict is still out.

    Fish Oil and Rheumatoid Arthritis: Published report (meta-analysis of randomized control trials) of high doses of fish oil and it's potential benefit in rheumatoid arthritis patients.

    Fish Oil and Psoriasis (inflammatory condition): Published review of Fish Oil as an adjuvant to standard psoriasis treatment protocol.

    Fish Oil and Lupus (inflammatory condition): Interesting presentation at the American College of Rheumatology Annual Scientific Meeting a number of years ago on the benefits of fish oil in lupus patients.

    One Last Thought on Studies of Nutritional Products: Many of these health associations with Fish Oil or any other nutritional product will take years to pan out a verdict, if at all. The problem is that it is very difficult to do clinical trials on nutritional products. There are too many confounders in our diet to truly isolate the benefits of one specific nutrient. What we do have are "associations" we can look into and do our best to draw conclusions from them.

    This article serves to take a larger view on Vascepa's potential than what's currently approved:

    "It's Not Just About the Triglycerides."

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Comments (28)
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  • studythosestocks
    , contributor
    Comments (31) | Send Message
    Very well written. Thank you for sharing your research
    29 Apr 2013, 06:15 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Thank You. A little bit more than just Amarin but I figure readers can benefit from hearing the whole Fish Oil story
    29 Apr 2013, 07:55 PM Reply Like
  • don55
    , contributor
    Comments (118) | Send Message
    what are the advantages of prescription fish oil over non-prescription fish oil such as krill oil... don't tell me it's just the quality.. there are many reputable companies that sell fish oil OTC.. this sounds like a bunch of bull to me..
    29 Apr 2013, 07:08 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Prescription Fish Oil is highly concentrated and purified through an FDA regulated/approved process. You pretty much know what you're going to get each time. OTC fish oil the dosages are variable but often you would need to take several OTC fish oil pills to get the same equivalent amount of fish oil as the prescription one. I also have not found any OTC EPA only fish oil on the market. They are typically a combination of EPA/DHA.
    29 Apr 2013, 07:58 PM Reply Like
  • sts66
    , contributor
    Comments (3463) | Send Message
    O3Mega plus Joy is concentrated EPA, costs $30/120 caps at Vitacost.com, but you'd have to take 8/day to get the same amount of EPA contained in Vascepa, making the cost ~ $60/month, and you'd also be taking 200 mg DHA/day, another 4000 mg/day of unknown fish oil fatty acids/esters, 20 mg of cholesterol/day, and 24 IU of Vit E (264% of recommended daily allowance) - Vascepa has none of that other stuff.


    I've had good results with various products sold on Vitacost, but in reality the purity of the fish oil used in O3Mega plus Joy is unknown (what's really in that extra 500 mg of "other fish oils" per capsule?), it may vary by lots since it's not made in an FDA approved/regulated/mon... facility, although they claim:


    "O3Mega+joy contains only pharmaceutical grade, molecularly distilled wild fish oils that are test by IFOS showing no detectable levels of oxidation, or contaminants including heavy metals, dioxins or PCBs.
    Free Of
    Artificial colors, flavors, sweeteners, preservatives, corn, dairy, egg, wheat, gluten, soy and yeast. "


    Label/Ingredients for Genuine Health O3Mega plus™ Joy


    Take 2 softgels daily with food.


    Supplement Facts
    Serving Size: 2 Softgels
    Servings per Container: 60
    Amount Per Serving % Daily Value
    Calories 20
    Calories from Fat 18
    Total Fat 2 g 3%
    Saturated Fat 0.1 g <1%
    Trans Fat 0 g
    Cholesterol 5 mg 1.6%
    Vitamin E 20 IU 66%
    Fish Oil Concentrate 2000 mg *
    EPA (Eicosapentaenoic Acid) 1000 mg *
    DHA (Docosahexaenoic Acid) 50 mg *


    *Daily value not established.
    30 Apr 2013, 06:20 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Thanks for sharing! It's the 4000 mg/day of unknown stuff that worries me
    1 May 2013, 01:56 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
    Could not agree more, good informative article.
    29 Apr 2013, 08:48 PM Reply Like
  • Jolk
    , contributor
    Comments (309) | Send Message
    Great summary. One thought about the synergy between EPA and Statin is that statins raise Arachidonic Acid levels and higer AA levels leads to pro-inflammation.


    In the JELIS study, both study groups saw similar drops in LDL-C, the difference between the two was seen in Arachidonic Acid/EPA ratio and TRIG/HDL ratio. EPA counters higher levels of Arachidonic Acid as they are both involved in the inflammation pathways we all have.
    29 Apr 2013, 09:23 PM Reply Like
  • Jolk
    , contributor
    Comments (309) | Send Message
    EPA's importance in stabilizing vasculature.


    Atherosclerosis. 2013 Mar 13. pii: S0021-9150(13)00171-8


    Modulation of endothelial progenitor cell number and function with n-3 polyunsaturated fatty acids.


    " Incubation with DHA and EPA, either alone or in combination significantly increased the number of EPCs and colony forming units (CFU). In addition, co-incubation with DHA + EPA, significantly enhanced EPC migratory capacity, adhesive properties and greater incorporation into tubules. Thus, EPA + DHA are effective in improving EPC number and functionality in-vitro."
    29 Apr 2013, 09:28 PM Reply Like
  • Jolk
    , contributor
    Comments (309) | Send Message
    "Eicosapentaenoic acid reduces warfarin-induced arterial calcification in rats."


    "EPA showed a marked reduction of medial calcification in the EPA group, and showed a similar effect in the late EPA group. Immunohistochemical and RT-PCR analyses showed that EPA lowered the expression of osteogenetic markers, such as osteopontin, alkaline phosphatase and core binding factor-α1 in the aorta. Significant migration of macrophages with expression of matrix-metalloproteinase (MMP)-2 or MMP-9 was observed in the aortic adventitia around calcification. EPA also reduced macrophage infiltration, MMP-9 expression as well as gene expression of monocyte chemotactic protein (MCP)-1."
    29 Apr 2013, 09:30 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Good links. Potential mechanisms of action for cardiovascular health. Especially if you're a rat :)
    29 Apr 2013, 11:28 PM Reply Like
  • Gary Head
    , contributor
    Comments (281) | Send Message
    Great article and very well written
    I will just report a different view on OTC ( dietary supplement ) fish oils as presented to me by Cardiologists at UCSF .
    They maintain that if you thoroughly research the reviews of dietary supplement fish oils on ConsumerLab .com you can find fish oil supplements of good reliable quality to achieve much of the benefits of Vascepa....and that's what they suggest to their patients until the Reduce Outcome trial data is out .
    Appreciate your comments
    29 Apr 2013, 10:04 PM Reply Like
  • onecardchuck
    , contributor
    Comments (36) | Send Message


    Once you take Vascepa for a few months and feel the effects and see your blood work results. Trust me you you will never again make the mistake of saying OTC can do what Vascepa can do for you. Because there is nothing else even close.


    Hope this helps,
    29 Apr 2013, 11:00 PM Reply Like
  • Gary Head
    , contributor
    Comments (281) | Send Message
    Onecard....yes your comments help ...just need to convince my docs .. who aren't convinced without outcome data ..
    Anyway we know Vascepa works ...just look at how mellow JL 's comments are now .....no more " off with their heads " attitude of YMB days since he's been on Vascepa :)
    29 Apr 2013, 11:17 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Hi Gary,


    It's true that most docs want to see outcome data, including myself. There are products on the market the "lowers this" or "improves that" but when you look at the end point of mortality, morbidity, or in the case of cardiovascular medications our end points would be cardiac events: Heart attacks, congestive heart failure, stroke, etc, etc. It's not uncommon that the outcome does not reflect what the assumed goal the product is supposed to achieve. Take a look at the THRIVE2 study I posted above - niacin will lower triglycerides, improve good HDL cholesterol, but the Outcome did not show improvement in reducing cardiovascular events compared to the control group.
    29 Apr 2013, 11:38 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » There are 2 main problems with comparing the benefits of Vascepa to OTC fish oil.


    1. If you drop by your local CVS Pharmacy, Walgreens, etc and look specifically for Purified EPA Fish Oil - you won't find any. The OTC Fish Oil all have a combination of EPA/DHA. I haven't been able to find a Pure EPA fish oil OTC yet.


    2. This takes us to the second problem: The reason Lovaza is inferior to EPA Fish Oil is that Lovaza has an "Elevation of LDL Cholesterol" Warning on its label. The Risk of LDL cholesterol increase has been attibuted to the DHA Component of it's fish oil. So while DHA has other health benefits, the OTC Fish Oil faces the same concerns as Lovaza due to their similar DHA/EPA combination.




    The change in low-density lipoprotein cholesterol concentration is positively related to plasma docosahexaenoic acid but not eicosapentaenoic acid.
    Itakura H, Yokoyama M, Matsuzaki M, Saito Y, Origasa H, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K, Matsuzawa Y; JELIS.
    Shinagawa East One Medical Clinic, Minatoku, Tokyo, Japan. shinagawa-east-one@joz...
    The Japan EPA Lipid Intervention Study (JELIS) reported a 19% reduction of the risk for coronary artery disease after long-term use of pure eicosapentaenoic acid (EPA) in Japanese patients with hypercholesterolemia. The variation in plasma fatty acid composition influenced the risk of coronary events. The aim of this study was to examine in JELIS participants the possible correlation of changes in plasma fatty acids with those of serum lipids.
    The coefficient for the correlation between the absolute change in plasma fatty acid concentrations and the changes in serum lipids was calculated in 13,901 JELIS participants.
    Low-density lipoprotein (LDL) cholesterol exhibited a positive correlation with docosahexaenoic acid (DHA; r=0.117 in control group, r=0.155 in EPA group) and linoleic acid (r=0.139 in control group, r=0.177 in EPA group), but the correlation coefficients with EPA (r=0.097 in control group, r=-0.032 in EPA group) were less than 0.1. We distributed the patients into 9 groups according to tertiles of the change in EPA and DHA. The average absolute decrease of LDL cholesterol and L/H ratio in each group was significantly smaller (p<0.001) in the DHA-high tertile, but not in any EPA tertile.
    The changes in DHA, but not in EPA, showed a positive correlation with the changes in LDL-cholesterol.
    29 Apr 2013, 11:48 PM Reply Like
  • sblfe
    , contributor
    Comments (14) | Send Message
    Gary- I am surprised your docs would recommend that you go w/ a good ds when the out of pocket cost vs vascepa would actually be more for the ds (i'm assuming you are covered). If they wanted to see results first, they should tell you NOT to take the ds. Not very logical in my book. You either don't suggest any fish oil supplements or you go w/ the best- especially if its cheaper out of pocket to the patient.
    30 Apr 2013, 01:37 AM Reply Like
  • Jessellivermore
    , contributor
    Comments (53) | Send Message


    LOL....":>) JL
    30 Apr 2013, 06:51 AM Reply Like
  • tobingj
    , contributor
    Comments (100) | Send Message
    Funny Post Gary- I had to laugh at that..... I think it is just that there are educated comments here. He is happier with a higher level of intellect. Were as on YMB it was a barrage of poor quality posts. Impossible to find good input there.
    23 May 2013, 04:55 AM Reply Like
  • jeichmeier
    , contributor
    Comments (5) | Send Message
    Thanks for second article Doc! Excellent DD
    29 Apr 2013, 10:10 PM Reply Like
  • ajbrzoz
    , contributor
    Comments (68) | Send Message
    Great article! Thank you!
    30 Apr 2013, 01:13 AM Reply Like
  • Jessellivermore
    , contributor
    Comments (53) | Send Message
    Excellent article Iggy....


    Let the message go forth to all across the land..


    Will add some comments...All positive...meanwhile gotta go to work..


    ":>) JL..
    30 Apr 2013, 06:55 AM Reply Like
  • MoneyQ
    , contributor
    Comments (6) | Send Message
    Excellent article.
    I'm curious....why release as an instablog instead of an article that links to the Summary page in Yahoo?
    30 Apr 2013, 08:59 AM Reply Like
  • chunk713
    , contributor
    Comments (41) | Send Message
    Great read. Very informative and well laid out. Says it all about Vascepa! Thank you.
    30 Apr 2013, 11:07 AM Reply Like
  • tobingj
    , contributor
    Comments (100) | Send Message
    Ahh- there you go - expected you to have a decent article somewhere. Excellent summary of the history of AMR-101 and developments over time. It is a very important drug and the bulls dont seem to be able to put that into words. You have done an excellent job. Now it is just time and patience. Thanks.
    22 May 2013, 06:19 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Thanks! I did not publish it as a regular article (instablog instead) - maybe will get it published through the regular route.
    22 May 2013, 07:48 PM Reply Like
  • Jolk
    , contributor
    Comments (309) | Send Message
    Vascepa facts and tidbits:
    22 May 2013, 07:55 PM Reply Like
  • Iggy Igette
    , contributor
    Comments (157) | Send Message
    Author’s reply » Nice info!
    23 May 2013, 09:00 AM Reply Like
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