Sephy Philip, PharmD: The ANCHOR Trial

Sephy Philip, PharmD, the senior director of medical affairs at Amarin Pharma, Inc., sat with MD Magazine at ACC.18 to discuss the results of the ANCHOR trial, which was presented at the conference. Philip also discussed the subgroup analysis of the ANCHOR data, which showed consistencies across databases.

Sephy Philip, PharmD:

So the ANCHOR trial, as you may or may not know, was a 700+ patient lipid trial looking at patients who have elevated cardiovascular risk as denoted by high triglycerides despite statin therapy. Some of these patients had an existing cardiovascular risk—they may have a heart attack or stroke—and other patients had diabetes plus one or more additional risk factors. So it was a high CV-risk patient population that received either prescription pure ethyl-eicosapentaenoic acid (Vascepa) at 4 g per day or placebo. We looked at triglycerides, other lipids, lipoproteins, and inflammatory biomarkers, and what the overall ANCHOR trial showed in this high-risk patient group is that 4 g of Vascepa significantly reduced triglycerides and other lipids, lipoproteins, and inflammatory biomarkers, including hsCRP.

What we'll be presenting on Monday is a subgroup of patients who had, at baseline, elevated inflammation. So these patients had hsCRP levels of 2 mg/L or greater. We know from epidemiology and, actually, even recent outcomes data, that patients with elevated inflammation as denoted by hsCRP are at higher risk of future cardiovascular disease. So that's the subgroup that we looked at, specifically because that subgroup will also be in a cardiovascular outcomes trial that we are conducting and will be finishing up called REDUCE-IT.

In addition to the ANCHOR subanalysis, we're also going to be looking at one particular risk group, which is patients who are controlled as far as LDL-C on statin therapy, but despite being controlled with statins and lower LDL-C (or at least less than 100 mg/dL) they are persistently high triglyceride groups. What we're looking at and the data we're presenting is cost and future cardiovascular risk data from both the Kaiser database as well as the Optum database. Optum is a pharmacy benefits manager that covers over 100 million lives—we looked at their data and Kaiser data.

It's not an interventional trial, it's really just looking at real-world data to show, over a 5-year time period, what is the future incremental cardiovascular risk in patients who are on statin therapy whose LDL-C is less than 100 mg/dL but they have persistently high triglyceride levels. We'll be presenting that data as well, we presented part of that data the past AHA meeting with patients who have triglycerides 200 mg/dL and over, and on Monday will be patients who have triglycerides of at least 150 mg/dL and greater.

What you see is that over a 5-year period, there is certainly an incremental increased risk in these patient groups with both elevated and high triglycerides. We looked at the major adverse cardiovascular events (MACE), which is a composite of heart attack, stroke, death from either cardiovascular or all causes, revascularization—so getting a stent in—or being hospitalized for chest pain or unstable angina. That was the composite MACE that we looked at in this real-world data, and what we saw, at least from the AHA data that we presented, is that there's a 35% greater increased risk of cardiovascular events in these patients who are on statin therapy, LDL-C less than 100 mg/dL, but have triglycerides of 200 mg/dL or more. That was primarily driven by heart attack, stroke, and revascularization for the Optum database, and similarly, for Kaiser, it was, again, an increased overall composite event rate in the high triglyceride group, driven very similarly, by heart attack and revascularization. So with both datasets, you see a consistent sort of increased risk that's driven by heart attack and procedures like having stents put in.