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Sunday, February 09, 2014 12:54:19 AM
Well, 99% of clinicians out there would still treat patients with TG between 200-499. Worse, clinicians continue to prescribe fibrates, niacin and Lovaza to treat those patients despite laundry list of side effects and proven failure of outcome trials. Before Oct 16, 2013, FDA's thinking was TG between 200-499 should be treated. How do I know? Otherwise, FDA shouldn't have the need to design the ANCHOR SPA with Amarin back in 2011 and accepted the ANCHOR sNDA at end of 2012. Moreover, even FDA's own website says TG between 200-499 needs to be treated, LOL! So to not treat patients with TG between 200-499 from now on, the FDA needs to put forth a bulletproof theory to explain why TG between 200-499 shouldn't be treated because American lives and health is on the line here. FDA can't use ACCORD, AIM-HIGH or THRIVE as a valid theory because the test subjects of those trials have medium TG much below 200. In fact, the subgroup analysis of those trials further validates that TG between 200-499 needs to be treated. If I explain all these to a 10-yr old, he'll be able to comprehend my reasoning, but not the FDA.
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