Paul Dobesh, PharmD, FCCP, BCPS, discusses the data regarding the use of DOACs in obese patients with VTE.
Jessica Kerr, PharmD, CDE: I would like to just switch gears with another obese population when we’re looking at treatment for acute DVT or VTE of any sort. Paul, give us some takeaways from those trials of DOACs and whether they support their use and how they are in comparison with other gold standards or older gold standards.
Paul Dobesh, PharmD, FCCP, BCPS: Sure, that’s a great question. I’ll tell you this: There are a lot less data with VTE than there is with A-fib. If you were to do a literature search and try to figure out, what do we know about obesity in the setting of A-fib with DOACs? We were just running through 4 or 5 studies. In the setting of each VTE, the data are much more limited. That kinetic study still holds true. The drug concentration with rivaroxaban in heavier patients will stay the same. That’s not consistent with other DOACs. One of the major papers in this section once again comes from those same authors from the University of Connecticut, Costa and Coleman. They did an electronic medical record study, with long follow-up of 2 years. Basically, we’re able to show a significant reduction in recurrent VTE events in obese patients versus using warfarin. These are real-world data. This isn’t a randomized controlled trial. Because they didn’t use claims data, they actually used electronic medical records. They were able to accurately get good BMIs at the start of therapy. They did a nice job of splitting patients up, as Matt described earlier: class 1 obesity of being 30 to 35, then 35 to 40, and then greater than 40. What was really interesting is that the magnitude of benefit of rivaroxaban over warfarin was consistent even in the patients with BMIs over 40. In fact, the point estimate there was actually the smallest of the 3 groups. Obviously the number of patients in that group is going to be less than some of the others. The data were very consistent across all levels of obesity for this benefit. They found that safety was consistent with that of warfarin therapy, once again, consistent across all the BMIs. When I was analyzing those data, it was not only, “OK, there is a benefit.” I was trying to figure out, was there a trend moving in 1 direction versus the other based on different BMI classes? Not at all. That’s actually very reassuring for me. I’m not personally familiar with obesity data with the other DOACs in the setting of VTEs. We’re just continuing to wait for evolving information there.