Mohamed Eid, MD, MPH, MHA: EMPRISE Data at AHA 2019

This week at the American Heart Association (AHA) 2019 Scientific Sessions in Philadelphia, Boehringer Ingelheim (BI) will share new data from the EMPRISE study—a database comparative assessment of empagliflozin (Jardiance) versus DDP4 inhibitor therapies in real-world patients with and without type 2 diabetes.

The findings, as Mohamed Eid, MD, MPH, MHA, suggested to MD Magazine®, complement the pivotal findings of EMPA-REG in a clinical setting, and add context to the SGLT-2 inhibitor therapies’ effect on comprehensive patient care, relative to its competitors.

In an interview with MD Mag while at AHA, Eid, vice president of Clinical Development & Medical Affairs, Cardiometabolism & Respiratory Medicine for BI USA, explained the focus of the EMPRISE study, and its implications in the field.

MD Mag: What were the findings of the new EMPRISE data being presented at AHA 2019?

Eid: The EMPRISE data is one that actually comes from a significant US claims database, as well as a Medicare database in the US. It actually describes, very widely, a significant number of people with cardiometabolic conditions that actually live with these conditions every day.

The aim of the EMPRISE dataset is to really try to replicate or validate the results we have seen in controlled, clinical trials in the landmark EMPA-REG study. It actually showed that empagliflozin (Jardiance) not only can improve diabetes outcomes, but also it could improve the outcomes of cardiovascular death in people with type 2 diabetes and established cardiovascular disease.

So, it's very important for us to try and see how and to what extent the effects we have seen in the clinical settings are ones that actually can translate into routine practice. And that's the whole idea of the EMPRISE database. It's a very large, observational study that will include over 150,000 records from those database sources.

We'll be looking at 2 main areas of interest. One is to look at the clinical outcomes that will describe the effects of empagliflozin compared to other medications that actually are being treated to help improve outcomes or conditions such as diabetes, such as DPP-4 inhibitors.

Also, it will compare Jardiance to the other medication class, GLP-1 receptor agonists. The comparisons here will be real-world, so they will actually integrate all data from all sources. But we'll look at 2 main domains. One is clinical outcomes, and another is the healthcare utilization—to what extent does clinical outcomes actually have impact on what we consider as healthcare resources such as hospitalization, emergency room visits, length of stay in the hospital, doctors visits, and so on.

At the same time, we also want to look at the total cost of care—not only to replicate the clinical outcomes and look at the healthcare utilization. We could plug this into some modeling to give us a sense of what impact this might have in terms of healthcare budget and costs.

MD Mag: What is the significance of comparing the three heart failure drug classes in real-world patients?

Eid: Of course, as you know, there are many options now, as we are pleased to see, for type 2 diabetes that physicians can choose from to try to customize therapy. Jardiance is the most commonly prescribed SGLT-2 inhibitor in the US, and it's important to us to understand how it fares against some of the other widely used medications.

The DPP-4 inhibitor class is the one that is also very widely used to treat type 2 diabetes, even though the effects on cardiovascular outcomes has been shown to be safe. But the studies have not really shown the impact that Jardiance has seen in a controlled setting, even though there were no direct head-to-head comparison studies.

So, it's important that we have a bit of a parallel to understand how Jardiance could actually perform in the clinical setting, compared to one of the other widely-used clinical classes.

In terms of the GLP-1 receptor agonist class, it's also one that has been more widely used, but one that shows some benefit in cardiovascular outcomes in people with type 2 diabetes as well. And it's important for us to, again, see how they fare in the clinical setting, where you have many other factors that perhaps didn't play a role in the controlled, clinical trial environment.