Implications of Potential Heparin Shortage - Episode 6
Manesh R. Patel, MD: More recently rivaroxaban has had this approval for medically ill patients based on a variety of clinical trial data. I wonder, what do you think about that? How compelling is that? Is this practice changing? [What] do you think about that?
Sarah A. Spinler, PharmD, FCCP, FAHA, FASHP, AACC, BCPS, AQ-Cardiology: When you look historically, the 2018 ASH [American Society of Hematology] medical prophylaxis guidelines did not recommend at the time extended duration. [If you look at] the data you had with APEX and betrixaban, and the data that you had with MAGELLAN and MARINER trials, and a meta-analysis, while there certainly was a nice reduction in their composite end points that include even symptomatic DVT [deep vein thrombosis], VTE [venous thromboembolism] death, as a composite end point of a large percentage, 40%, there was still an increased risk of major bleeding. So they did not recommend it at the time. What was interesting about their approach to the rivaroxaban approval is that they basically looked at, “OK, why don’t we try a more individualized approach?” Right now, it’s not something that’s widely available or in a paper that you look at. But certainly, when drugs get approved—and I think we learned this way back when dabigatran was approved—the FDA does things that no one would have suspected the FDA does.
When you look at this analysis, they basically looked at an analysis that said, let’s try and get rid of the patients [who] have the highest risk for bleed, since that seems to be the issue with all the DOACs [direct oral anticoagulants] necessary in medical prophylaxis—again, comparing [with] subcutaneous enoxaparin. Looking at extended prophylaxis versus in-hospital prophylaxis, again, you’re exposing the patient to a longer duration of an anticoagulant, so there’s certainly potential for bleed there.
Let’s look at the patients at highest risk for bleeding, exclude those from the analysis, and then look at it again. If you look in that regard for some of the high-risk features of bleeding, that’s kind of what made [it] into the product label. For now, that’s what we have: the information that’s in the product label that’s related to this analysis. And there’s information being presented at the AHA [American Heart Association Scientific Sessions] meeting, related to these in that patient group, specifically in heart failure. Again, we know how heart failure is very high risk for venous thromboembolism prophylaxis, especially in the need for extended prophylaxis, because [in] those patients their risk for a thrombosis actually extends for the duration of time that they have heart failure, which is…
Manesh R. Patel, MD: Is fairly large.
Sarah A. Spinler, PharmD: Yeah, it’s a long time. It’s a very chronic disease.
Transcript edited for clarity.