Replies to post #12388 on FDA Plays

[barefootrunner]

AMRN - same here. The closest thing I can find is mention that it is "available" in Japan. Will keep looking.

http://www.drugs.com/international/epadel.html

[olddogwithnewtrix]

Funny how some of the most basic stuff is the hardest to find. I can't see how it isn't. They have a ton of data on it. It will be available without script soon. EPA's dirty little secret is that it lowers HDL, this is why amrn did not mention this in the topline data. It was the one thing I did not like. But the lowering of TGs and 0 on the LDL is considered much more important than the 10-15% lowering in HDL. DHA raises HDL.

[io_io]

"do you know if Epadel is approved in Japan for those patients with triglycerides of =200 and <500 mg/dL ?"

No proof, but almost certainly yes, because of the 5-yr "Outcomes" trial (Jelis) that you see in the AMRN material. That trial was in TGLs as low as 150 I believe. That long-term stuff is the ultimate goal, the TGL stuff is only a marker of prediction for heart attacks and deaths.