A win for the triglyceride hypothesis!

REDUCE-IT™ CARDIOVASCULAR OUTCOMES STUDY OF VASCEPA® (ICOSAPENT ETHYL) CAPSULES MET PRIMARY ENDPOINT

Vascepa (purified eicosapentaenoic acid (EPA); Icoaspentyl ethyl) found to reduced 5-point MACE by 25%. This wasn't the strict 3-point MACE of BETonMACE and at this time we don't know which of the component(s) of the 5-point MACE were affected by Vascepa. This is 4 grams per day of purified EPA, not the unpurified fish oil that contains EPA, DHA and other non omega-3 oils or other purified preps that have both DHA and EPA. DHA, but not EPA, has actually been found to raise LDL. REDUCE-IT was a well designed trial with the proper patient population (high triglycerides), proper fatty acid (EPA), and proper dose (4g).

From the press release "Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 150-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort)."

Here's a published paper on the background of REDUCE-IT and here is the ClinicalTrials.gov listing.

I've posted a few times on Amarin before, so if interested you can look back at these threads for more info.

Amarin

The 3 inflection points: SSRA, Top-Line, Full Data

NIH Halts Large Cardiovascular Inflammation Reduction Trial (CIRT)

But from that most recent CIRT thread, here's a relevant bit on REDUCE-IT:

"Although apabetalone hasn't been shown to reduce plasma triglycerides like Amarin's Vascepa in the REDUCE-IT trial, both trials include diabetic/metabolic syndrome patients with hypertriglyceridemia. BETonMACE allows patients with up to 400 mg/dL baseline plasma TG (no minimum TG requirement); REDUCE-IT only allows patients in the 150-500 mg/dL baseline TG range. No overlap in mechanism of action between apabetalone (BD2-selective BET inhibitor) and Vascepa (purified omega 3 EPA). However, if apabetalone does improve insulin sensitivity and/or reduce liver fat accumulation, then apabetalone treated patients may experience a lowering of their plasma triglycerides. Personally, I'm cheering for REDUCE-IT to succeed and validate the TG hypothesis, but success or failure of REDUCE-IT really has no bearing on Apabetalone/BETonMACE."