VIDEO: Opportunities for improvement in anemia management in CKD

Editor’s note: This is a previously posted video, and the below is an automatically generated transcript to be used for informational purposes. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription.

The major opportunity for improvement in the treatment of anemia in patients with chronic kidney disease is among those patients who are not yet on dialysis. As I might have mentioned before, most patients are on dialysis. They get their ESAs through the extracorporeal circuit if they're on in-center hemodialysis, they get IV iron, it's needed to replace the iron losses. So for the vast majority of those patients, the treatment is adequate if not optimal, but we don't see a lot of unmet need, except for that percentage of patients that I mentioned before, where perhaps a better mouse trap that can overcome EPO hyper-responsiveness would be welcomed.

But for patients with non-dialysis chronic kidney disease, there is really an epidemic of anemia that's not adequately treated. It's estimated there are over two million patients in the United States who have anemia related to chronic kidney disease, and we're defining it as a hemoglobin less than 12, that are receiving either no treatment or inadequate treatment. Part of that is because of the barriers related to pareneal administration of ESAs that I mentioned. Part of it is the barrier to either oral iron adherence because of side effects or other reasons, and the barriers to receiving intravenous iron, which can be burdensome if a patient has to come to an infusion center, as well as the perception that treatment of anemia in those patients is not worth it. It's dangerous. ESAs has have this black box warning, and a lot of primary care physicians nephrologists, diabetologists, cardiologists, those main subspecialties that care for the lion's share of these patients are spooked by that black box warning. And that black box warning, as I said, is very restrictive. You can't start the ESA until the hemoglobin is less than 10, you have to taper or discontinue the ESA when the hemoglobin is greater than 10. I mean, how do you negotiate that tightrope? It's almost impossible. And a lot of people basically throw their hands up in frustration and say, I just can't treat these patients. And we let their hemoglobins drift down. And that adversely affects their quality of life and increases the risk for a transfusion, may actually increase the risk of progression of chronic kidney disease. I mean, there's lots of things that we're really not sure that we're missing the boat on, in the undertreatment of these patients.

So again, I think the availability of a new class of agents that can be administered orally, that overcomes the functional iron deficiency that they may limit oral iron absorption decreases the need for IV iron and trips to an infusion center, as well as allows for an FDA liberalization of the target hemoglobin level. 'Cause almost all the phase three studies using this new class of HIF stabilizers use target hemoglobins of 10 to 12. So it is hoped that once these ages are approved, the FDA label will have, in fact, a target hemoglobin level of 10 to 12, not a target hemoglobin level of 10, no more, no less, which is what we have now with ESAs. And I think if the black box warning is toned down or eliminated, and you have this more flexible target hemoglobin level, I think you're gonna get a lot of other specialists on board besides nephrologists and hematologists, including primary care physicians, diabetologists, and cardiologists that may be willing to use these agents, so that patients don't necessarily have to be seen and followed by a nephrologist in order to benefit from the use of these drugs.