Welcome. My name is Dr. Jean Elwing and I'm a professor of medicine and the Director of the Pulmonary Hypertension Program at the University of Cincinnati. We're going to be talking about measuring risk and the impact of Orenitram.

It's important to follow risk and reassess it routinely because otherwise you could possibly miss a change in patient status that could have been picked up earlier.

So if you see a patient and start them on a medication, it's not enough to ask them a few questions and see them six months later. We have to check in, and we can do that multiple ways.

We can do that virtually, we could do that face to face, but we need to do something in an organized way and see them back at a regular schedule, usually one to three months, depending on severity of illness and re-evaluate.

Those in between are the ones we have to watch with risk assessment. If they're having subtle functional capacity changes, decrease in their walk distance, increase in their BNP, changes on their echocardiogram, we need to pay attention. And when we're tracking that risk assessment, we can pick that up in a formal way.

The information from FREEDOM-EV can help us figure out when to add an oral prostacyclin to the medication regimen for our PAH patients. It is not something we want to go about doing when our patients have advanced hemodynamics and Functional Class IV symptoms. We want to think about Orenitram in our patients earlier in disease.

Adding Orenitram has been demonstrated to improve several key indicators of risk as well as overall risk. I think this is important because that is what we're watching in our patients with PAH and how medication is affecting them.

But when we looked at the secondary endpoints in FREEDOM-EV, we found other important risk modifications. 50 percent of patients taking Orenitram improved their walk distance by more than 25 meters at 36 and 48 weeks. 89 percent of them were able to improve or maintain their functional class at 24 weeks. 96 percent of the functional class II patients receiving Orenitram maintained three low risk criteria in the French assessment at 24 weeks, that was 27 out of 28 patients, as well as 36 weeks, 24 out of 25 patients.

So we're not just impacting worsening by adding Orenitram. We were impacting multiple non-invasive parameters that we use to assess risk globally in our patients.

So putting it all together, FREEDOM-EV was able to show us that Orenitram was able to impact multiple parameters of risk and overall disease progression in this long term study.