Origin 6 years study for Fish Oil sponsored by Fish Oil producers--failed to show the long term benefits of reducing Cardiac events(Heart related).
Recently Merck study in Europe and China failed to show benefits of Niacin.
Last year NIH sponsored study failed to show the benefits of Niaspan in reducing Cardiac events.
So the Cardiologists and other doctors are confused what to prescribe to prevent Heart attacks.
So here is 100% consensus:
1) Lipitor,Crestor,Zocor,Pravachol do reduce LDL and Cholestrols and long term studies have proven their effectiveness in "Reducing" Cardiac events.
2) Crestor is shown to be effective--if C-reative Protein is greater than 2.0. There is a test for C-rp and it is an indicator of inflammation in arteries. Dr.Topol,the top Cardiologist --formerly Chief of the Cleveland Clinic--liked C-rp test as a good indicator of on-coming heart -attack.
3) Lipitor was the top selling drug in the World--for its effectiveness in lowering LIPID Profile.
Niacin was used for people with high Trigylcerides for many years although it causes-"FLUSHING" and many people don't like it.
Fish Oil was used for lowering TRIGYLCERIDES and LOVAZA sold by Glaxo Smith Klein Beecham is approved by FDA for people with TG greater than 500mg./dl.
So what's the problem and why studies failed.
1) LOVAZA which contains EPA and DHA-- lowers TG by 51.6%,but raises LDL-C by 49.3% if you read its label(FDA) and it can cause Heart Atrial Fib.
So you trade lower TG for higher LDL-C.
2) LDL-C is proven to be bad for Cardiac events in many studies and that's why Lipitor became the best seller achieving 12.8 billion$ sales in 2011. Crestor also reduces LDL-C as do Zocor and Pravachol--but not as much as Lipitor or Crestor.
3) There is one very large study of 18645 Japanese men and women done in 1999-2005 that proved beyond doubt that 98% pure EPA with NO DHA reduces cardiac events. Dr.Saito took this 18645 persons data and looked at 14,981 persons with TG greater than 150 and HDL less than 40mg./dl. They found that the Cardiac events for this group dropped by 53% over 5 years.
Now Dr.Mitsuhiro Yokoyama,MD,Ph.d is a top Cardiologist in Japan who conducted this study with a few others at Kobe University. Dr.Saito of Chiba University is also a top Cardiologist . Dr.Yokoyama used 1800mg or 1.8gram/day of 98% EPA for their studies.In control group(Placebo),they used Zocor or Pravachol and for EPA group,they used 1800mg./day of EPA in addition to Zocor or Pravachol.
Dr.Darius Mozaffarian of Harvard commented on JAPENESE study--that on average Japanese consume 250mg./day of EPA thru their daily diet--which is far higher than Westerners. So basically to be effective--2grams/day of EPA is needed to lower Cardiac events.
EPADEL which was approved by Japanese FDA--has been used in Japan for many years in addition to STATINS. For some reason Mochida Corp. did not spend the money to sell it in USA as cost of FDA required studies is very expensive and time consuming.
If that is true,then how come American Cardiologists have wasted 5 years--after Dr.Yokoyama published the results in British journal LANCET?
It has to do more with SPONSOR-- Fish Oil and Lovaza has sponsors--but 98% pure EPA has NO sponsors. These studies are costly--can easily exceed 125 million$ over 5 years for 8000 persons. Also there is a company that holds patents for 96% pure EPA pills in USA and Europe.
There is one company in USA(that hold the patents) that has done its own studies for 729 persons for 12 months with 96% EPA and no DHA. FDA has approved their drug -VASCEPA for TG greater than 500mg./dl. persons and has asked them to do a long term study to prove its effectiveness in Reducing Cardiac events for people with TG of 200-500mg.
This study for 4 grams/day in addition to Statins is being done in USA,Europe and close to 4000 persons are enrolled and eventually 8000 will be enrolled by the end of 2013. This study called--REDUCE-IT is being conducted by a top cardiologist from Harvard--Dr.Deepak Bhatt--trained at the Cleveland Clinic and a full professor at Harvard. He is hopeful that VASCEPA may reduce Cardiac events like Japanese study--but we may have to wait till 2015 or 2016 to be 100% sure.
So while this study is going on --one could trust Japanese Study results and take VASCEPA which is 96% EPA with NO DHA.
VASCEPA(FDA label) says it reduces TG by 33% and reduces LDL-C by 2%(Statistician say-- VASCEPA does not raise LDL--as LOVAZA does raise it by huge 49.3%.).
VASCEPA is listed by FDA in Cardiac drugs.
So if your TG is high--talk to your Cardiologist or doctor about VASCEPA.