Friday, July 27, 2012

FDA approved a new medication for lowering triglycerides

The FDA approved AMR101. This is good news for every one with elevated triglycerides. I have attached my blog from last month for your review.

AMR101 , a new medication for lowering Triglycerides

 AMR101,  the moment of truth is approaching. The FDA will make a decision within the next few weeks on whether to approve or not approve this medications for the treatment of high triglycerides.

AMR101 is a prescription grade omega -3 -fatty acid that will hopefully be approved for the treatment of very high triglyceride levels over 500 mg/dl and the first in this class of medications approved for treating triglycerides in the 200 to <500 mg/dl range.

AMR101 is ultra pure 96 % EPA( ecosapentaenoic acid )
They have 2 studies documenting effectiveness and safety of this medication in reducing triglycerides with out elevating LDL levels. they also demonstrated favorable results with Apo b , Non - HDL cholesterol and inflammatory markers. the safety profile was comparable to placebo. ( Anchor trial and Marine trial ) another trial ( REDUCE-It ) to demonstrate the effectiveness in reducing the risk of cardiovascular disease  will be started soon.
Another study , Jellis study , using AMR101 was done in Japan and demonstrated effectiveness of 1.8 grams of purified EPA in reducing the risk of cardiovascular disease. Please see my Blogs from Jan.
 2012 for more details.
I believe this medication will be approved by the FDA and will be a useful addition in managing elevated triglycerides.

Have Fun , Be Smart and review the articles below and my other  omega 3 Fatty acid blogs from Feb..
David Calder, MD

Diabetes ,Triglycerides, Fish Oil and Heart Disease

Yesterday we discussed why the ACCORD study failed to demonstrate a reduction in the risk of heart disease with combination of simvastatin and fenofibrate .

For those of you who just want a quick summary of todays blog , just read the bold print.

Lowering Triglyceride levels and raising HDL Cholesterol is a continuing challenge. 
Life style changes with weight loss and increased exercise and correcting high glucose levels work to a certain degree .  Our choices of medications have been limited primarily to fibrates such as fenofibrate  , Niacin and Omega -3 -fatty acids ( fish oil ) .

 I was always reluctant to use fibrates because of the increased risk of Rhabdomylosis when combined with a Statin and Niacin was difficult to use because of site effects.   This left me with Omega -3-fatty acids that had its on set of problems. It was only recently that we had an FDA approved source of purified fish oil with each capsule  containing 840 mg of EPA =DHA. ( Lovaza). Cost became a factor because of the number of pills required to be effective.  All of the above resulted in my having patients use over the counter  brands of fish oil. Using over the counter medications made me uncomfortable but I did find that the results were good . I was encourage by a  recent article in Consumer Report  ( January 2012 page11) verifying that most of the over the counter brands did actually contain the amounts of EPA ad DHA found on the label.

 There is an article in the January 2012 Internal Medicine News that  is reviews more good news for us Fish Oil lovers. There may be another FDA approved source of fish oil available soon.

Fish Oil Works to lower Triglycerides
 AMR101 is pure EPA. There initial study (ANCHOR Trial ) was in a group of patients with high cardiovascular risk on Statins with LDL cholesterols of 100 mg/dl  or less and Triglyceride levels between 200 and 500 mg/dlAMR 101 2 gms/day and 4 gms/ day reduced triglycerides 10.1% and 
22 % respectively. 

 Another study  using the same medication was done in patients with fasting triglyceride levels of at least 500mg/dl .This study , MARINE Study, reported in the American J. Of Cardiology 2011;108:682-90 found that 2 and 4 gms/day of AMR101 reduced Triglyceride levels 20 % and 33 % respectively. 

These two studies provide more evidence that Omega 3 fatty acids work and seem to be more effective in patients with higher triglyceride levels.

Will Fish oil reduce my risk of developing heart disease ?
        stay tuned
                                                                       Have Fun , be Smart and Defeat Diabetes
                                                                       David Calder,MD


Omega -3 - fatty acids and Heart Disease

            Hint ; save 39.2 seconds of your time by just reading the highlighted area

We know that Omega 3 fatty Acids , EPA and DHA, in Fish Oil  reduce triglyceride levels but do they reduce the risk of having heart disease. 

There is one study done in Japan, Jelis Study (Japan EPA Lipid intervention Study) reported in Lancet 2007;369: 1090-8

 This study was included 18,000 patients with and without heart disease with total cholesterol of 251 mg/dl (6.5 mmol/L ) and LDL of 171 ( 4.4 mmol/L ) and randomized to a low dose statin alone or a statin plus 1.8 grams of EPA purified from omega - 3- fatty acids in fish oil and followed for an average of 4.6 years.
 Results ;
       Statin only group  --- ------------     3.5%  had a major coronary event
       Statin  plus 1.8 grams of EPA --   2.8%  had a major coronary event

A 19% relative risk reduction in the group receiving 1.8 gms of EPA

 There was a followup analysis of this study reported in Artherosclerosis 2009 may:204(1):233.
 This analysis looked at people in the Jelis study with elevated Triglycerides > 150 mg/dl and
  HDL < 40 mg/dl. In this higher risk group, EPA treatment resulted in a 53% relative risk reduction.

There is another planned study - REDUCE IT ( Reduction of Cardiovascular Events with EPA intervention trial ) that will specifically look at the effects of Triglyceride reduction  and cardiovascular risk. Hopefully this study , to be completed in 6 years ,will provide us with a more definitive answer .

For now , Omega 3 fatty acids , are still my first choice.

Have fun , Be Smart and Defeat Diabetes
David Calder,MD


Shopping for Omega -3 Fatty Acids can be confusing

 HINT-  Save 45.6 seconds of your day by just reading the bold print

Shopping for Omega- 3- Acids can sometimes be confusing. I was in a store yesterday that had at least 6 different brands of Omega -3 - fatty acids on their shelves.

My wife has elevated triglycerides and takes 4 to 5 grams of " Omega -3- FA" /day and I have normal triglycerides and take close to 2 gms/day.  The American Heart Association recommends 1 gm/day for someone without elevated triglycerides or heart disease. I have attached a copy of the American Heart Association recommendations below. The Jelis study , that we discussed on Jan. 30 , found a 19% relative risk reduction for a cardiovascular event by taking 1.8 gms of purified EPA for people with and without known heart disease or triglyceride problems.

I feel like a well informed consumer and had a simple goal of finding the smallest capsule with the highest amount of Omega -3 Fatty acids. My wife and I spent about 20 minutes reading labels using our calculator to find the pill that best met our goals. I have 3 different bottle setting in front of me now.

# 1 1200 mg of natural fish oil concentrate with 684 mg Omega -3 -Fatty acids
                              smaller print   EPA 410 mg
                                                     DHA 274 m
               Total amount /capsule---------  684

# 2   Fish oil 1400mg/980 omega-3
                                smaller print  EPA  647 mg
                                                     DHA 253 mg
                                                     other *****
               Total amount /capsule---------- 900 mg 

# 3   Cod Liver Oil    high in EPA and DHA /   Omega - 3 - Fatty acid 1100 mg
                                 smaller print EPA   400 mg
                                                      DHA  500 mg
                                                      Other *****
               Total amount per teaspoon          900 mg

I am not sure which omega -3 fatty acid is named  "other ".  I personally prefer to use EPA and DHA because they have been shown to be effective. We chose #2 because it  had a little more Mg / capsule than #1 and also had more EPA and less "other" than #3.  

I plan to take 2 capsules /day and my wife will take 5 capsules /day. We have lipid panels scheduled for next month.

What is in  that "Other " category ?   What is alpha  linolenic acid ?  Find out tomorrow.

                                                                                                          Happy shopping,
                                                                                                          David Calder, MD
My friend , a  fellow blogger and founder of 1  and Laffing at Life is shopping for Omega 3's today and  may have a comment  about his experience.


Fish is a good source of protein and, unlike fatty meat products, it’s not high in saturated fat. Fish is also a good source of omega-3 fatty acids.  Omega-3 fatty acids benefit the heart of healthy people and those at high risk of — or who have — cardiovascular disease.  Research has shown that omega-3 fatty acids decrease risk of arrhythmias (abnormal heartbeats), which can lead to sudden cardiac death. Omega-3 fatty acids also decrease triglyceride levels, slow the growth rate of atherosclerotic plaque and lower blood pressure (slightly).
AHA Recommendation
We recommend eating fish (particularly fatty fish) at least two times (two servings) a week. Each serving is 3.5 oz. cooked, or about ¾ cup of flaked fish.  Enjoy fish baked or grilled, not fried.  Choose low-sodium, low-fat seasonings such as spices, herbs, lemon juice and other flavorings in cooking and at the table. 
Fatty fish like salmon, mackerel, herring, lake trout, sardines and albacore tuna are high in two kinds of omega-3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which have demonstrated benefits at reducing heart disease.
We also recommend eating tofu and other forms of soybeans, canola, walnut and flaxseed, and their oils. These foods contain alpha-linolenic acid (ALA), another omega-3 fatty acid. Large-scale epidemiologic studies suggest that people at risk for coronary heart disease benefit from consuming omega-3 fatty acids from marine and plant sources. However, more studies are needed to show a cause-and-effect beneficial relationship between ALA and heart disease.
Increasing omega-3 fatty acid consumption through foods is preferable.  However, coronary artery disease patients may not be able to get enough omega-3 by diet alone.  These people may want to talk to their doctor about taking a supplement.  Supplements also could help people with high triglycerides, who need even larger doses. 
Patients without documented coronary heart disease (CHD)
Eat a variety of (preferably fatty) fish at least twice a week. Include oils and foods rich in alpha-linolenic acid (flaxseed, canola and soybean oils; flaxseed and walnuts).
Patients with documented CHD
Consume about 1 g of EPA+DHA per day, preferably from fatty fish.  EPA+DHA in capsule form could be considered in consultation with the physician. 
Patients who need to lower triglycerides 
2 to 4 grams of EPA+DHA per day provided as capsules under a physician’s care. 
Patients taking more than 3 grams of omega-3 fatty acids from capsules should only do so under a physician’s care.  High intakes could cause excessive bleeding in some people.
Benefits vs. Risks of Eating FishSome types of fish may contain high levels of mercury, PCBs (polychlorinated biphenyls), dioxins and other environmental contaminants. Levels of these substances are generally highest in older, larger predatory fish and marine mammals.
The benefits and risks of eating fish vary depending on a person’s stage of life.
  • Children and pregnant women are advised by the U.S. Food and Drug Administration (FDA) to avoid eating those fish with the potential for the highest level of mercury contamination (e.g., shark, swordfish, king mackerel or tilefish); to eat up to 12 ounces (two average meals) per week of a variety of fish and shellfish that are lower in mercury (e.g., canned light tuna, salmon, pollock, catfish); and to check local advisories about the safety of fish caught by family and friends in local lakes, rivers and coastal areas.
  • For middle-aged and older men and postmenopausal women, the benefits of eating fish far outweigh the potential risks when the amount of fish are eaten is within the recommendations established by the FDA and Environmental Protection Agency.
  • Eating a variety of fish will help minimize any potentially adverse effects due to environmental pollutants.
Potential exposure to some contaminants can be reduced by removing the skin and surface fat from these fish before cooking. Consumers should also check with local and state authorities about types of fish and watersheds that may be contaminated and visit the FDA Web site for the most up-to-date information on recommendations for specific subgroups of the U.S. population (e.g., children, pregnant women).
Top 10 Fish and Shellfish in the United States Based on Consumption – Omega-3 and Mercury Levels:

Omega-3 fatty acids
(grams per 3-oz. serving)
Mean mercury level in parts per million (ppm)
Canned tuna (light)
Salmon (fresh, frozen)
Flounder or sole   
* ND – mercury concentration below the Level of Detection (LOD=0.01ppm)
Fish with the Highest Levels of Mercury (about 1 ppm):

Omega-3 fatty acids
(grams per 3-oz. serving)
Mean mercury level in parts per million (ppm)
Tilefish (golden bass or golden snapper)
King mackerel
Five of the most commonly eaten fish or shellfish that are low in mercury are shrimp, canned light tuna, salmon, pollock, and catfish.    Avoid eating shark, swordfish, king Mackerel, or tilefish because they contain high levels of mercury.

1 comment:

  1. Great blog..... This is very useful and included many important things. Thanks for shearing this information.

    triglycerides levels


Your comments and questions are appreciated. David Calder,MD