Tuesday, June 26, 2012

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

1 comment:

  1. If mangoes can really lower your tryglyceride level, they might be the next superfood. But the experts behind the study explain that a lot more experiments are required to say for sure, and it's too soon to tell if mangoes will assist individuals who already possess high triglyceride levels.

    triglycerides diet


Your comments and questions are appreciated. David Calder,MD