Questions received during this symposium have been paraphrased
and the answers submitted by the panelists are presented.
How would you manage IV iron in an individual who developed rash and urticaria to previous IV iron sucrose 500-mg infusion?
Would you consider IV iron replacement in an individual with a hemoglobin of greater than 11.6 with a TSAT less than 10% and ferritin less than 200?
What about giving IV iron to patients with infection?
How would you manage iron in an individual who developed rash and urticaria to previous iron sucrose?
When giving iron sucrose IV push, if you start an IV, do you physically deliver the push over 2 to 5 minutes in the vein from a needle attached to a syringe?
How often does one need to dose IV iron to keep iron measures in the target range?
In the slide about the percentages about family practicioners' comfort level, do the percentages add up to 100?
What factors predict who will respond to iron therapy alone? How do you know upfront which one-third of patients will not need EPO?
Do you have any reasons why so many CKD patients are iron deficient, especially with no history of blood loss or malabsorption?
If oral and IV iron are equal, is there a benefit to giving both to patients having difficulty in maintaining good stores?
What type of iron therapy do you recommend for a patient who is very sensitive to IV iron, the patient is allergic to every IV iron on the market?
Here is a financial question: Some hospitals and corporations set up best practices for early diabetes and so forth in the years past. Many have closed because of expense, lack of profit. Is there a financial incentive for a primary care provider to support CKD clinics?
Questions here about pediatrics, and I am sorry we did not have any pediatrics in our study. We simply just do not work with children. There is a question whether or not we feel that our children are also at greater risk of death with anemia then progressing to ESRD.
In PD patients, do you use the same rate of administration in your practice?
Panelist Responses(Back to question index) How would you manage IV iron in an individual who developed rash and urticaria to previous IV iron sucrose 500-mg infusion?
Ms. Copeland: In my experience, reactions like that which you are seeing are based on the dose of IV iron and how it is administered. I would feel comfortable to give a lower, 250-mg dose. I might give a Benadryl ahead of time or something and then see how the patient does, but I think that with a lower dose, the patient would be fine.
(Back to question index) Would you consider IV iron replacement in the individual with a hemoglobin of greater than 11.6 with a TSAT less than 10% and ferritin less than 200?
Ms. Copeland: Hemoglobin over 11.6? Once you get those iron stores replaced, both hemoglobin and hematocrit are going to go shoot up. It is like putting gasoline on the fire. Usually we let the hemoglobin get under 11 before doing giving IV iron. So, I would give it a little leeway. I would be somewhat cautious just simply because they are going to need it. The Hb is going to start drifting down, especially if you adjust their EPO if they are getting EPO, but be cautious; it is amazing the response that you get. Once you get their iron stores in target, the Hb really can shoot out of target after that..
(Back to question index) What about giving IV iron to patients with infection?
Dr. Reed: Data about infection and iron is mostly in vitro and the evidence for that is really only for Staph aureus, and that is not our main bug. I cannot recall when we have had a Staph aureus infection back in the CKD clinic, but even in the hemodialysis patients, where there is positive literature, if you read those articles closely, these references to the injury from iron. In fact one of the authors that wrote it, one of them said he did not know what it meant because the dosages they used in the test tubes that showed impairment of various responses were superphysiologic, in fact, 10 times the amount of iron you should give, or 100 times. But the message I have gotten out of all of the above, is do not give too much iron and follow your protocol. We have limited giving IV iron in patients with ferritins greater than 800 at one time, and now over 500; but if you look at the data, most of the data on iron being harmful, it being deposited into tissue and relating to infection, it was in the transfusion days when we were looking at serum ferritin levels of 1100 and 1300. The committee ratcheted all this down to 800 - and where did they get this number from? I think they pulled it out of the sky - but much is being made about the infection risk. Currently, we only restrict IV iron if we have positive blood cultures that warrant treatment. I hope that answers your question.
(Back to question index) How would you manage iron in an individual who developed rash and urticaria to previous iron sucrose?
Dr. Reed : The question there is basically did iron sucrose cause this, or was it the rate and the amount administered? I will tell you this that there are some 80 to maybe over 100 patients now that had intolerance to one drug or another, and that iron sucrose is yet to show a reaction. In my opinion, all reactions (due to iron sucrose) are due to rate of administration.
(Back to question index) When giving iron sucrose IV push, if you start an IV, do you physically deliver the push over 2 to 5 minutes in the vein from a needle attached to a syringe?
Ms. Copeland: Usually what our nurse says is, that she uses just a butterfly needle which she just hooks up to the syringe, and then, over 2 to 5 minutes, one just pushes it in; it is very simple.
(Back to question index) How often does one need to dose IV iron to keep iron measures in the target range?
Ms. Copeland: I guess that really gets back to the patient. We did have our protocol, depending on how deficient they were, how many weekly doses either x4 or x2, and then we would recheck. If the patients were in target range, and we felt comfortable where they were in the target range, we would recheck their iron stores quarterly and then from that point on, decide on further maintenance dosing.
(Back to question index) In the slide about the percentages about family practicioners' comfort level, do the percentages add up to 100?
Ms. Copeland: The percentages did not add up to 100 because it was one of those surveys where it said check all which apply; e.g., do not refer because you do not have communication. So they could check more than 1 choice. So, that is how that ended up more than 100 percent.
(Back to question index) What factors predict who will respond to iron alone? How do you know upfront which one-third do not need EPO?
Dr. Reed: I think I got this answer way back from my RN who has had so much experience with this. Betsy and I gave her the protocol. She kept coming back to us - you missed the iron saturation, ferritin is very low, hemoglobin is pretty low, GFR is under 45. A slide that I showed there showed the factors that predict the response, and these factors were present in most of those patients. I guess in some people, we might not have known they would respond, and that is the reason now that we do not start EPO until we have them iron-repleted. I think anecdotally we have seen those patients in the CKD clinic, and I am not talking about hemodialysis, where 98% of patients need EPO, but in the CKD clinic we have seen that if we give both, they are responding by the predictions. If they go to a Hb of 15 g/dL, the blood pressure may go up. We give the iron first, and there are patients as you said, one-third maybe, who do not need any EPO.
(Back to question index) Why are so many CKD patients are iron deficient, especially with no history of blood loss or malabsorption?
Dr. Reed: I think it is multifactorial. Having been a real doctor for 19 years of my 30 where I did both internal medicine and nephrology, there are an enormous number of people bleeding intermittently from NSAIDs and all the other things that people take and develop from this problem, and even hyperparathyroidism has been associated with ulcer disease and in this era of PPIs, where everybody has GERD and reflux, this group of patients are not that well treated and GI bleeding is often intermittent and is significant. We actually in our protocol when we find them deficient and they fall out for one reason or other, we have got an algorithm that we follow, but most of the time we will check to include the blood. If they are negative and they are terribly deficient, we will often send those people for GI workup, and we find something all the time - we find polyps -and these are regular people who have all these other problems too. We just gang them all up in one room. But I think absorption is another big issue and anorexia. As you know from your hemo experience, the people who are on EPO twice a week on hemo days tend to be more malnourished, and I think all those are factors - it is just absolutely a multifactorial issue.
(Back to question index) If oral and IV iron are equal, is there a benefit in giving both to patients having difficulty in maintaining good stores?
Dr. Reed : We have not found that oral iron adds anything. If you look at 6 or 7 weeks into this, you cannot get the ferritin up based on that slide I showed you with oral. And then the side effects -a substantial number of people drop out of those studies because of GI symptoms, and they are already having a significant amount of GI bleeding. It is always difficult to monitor this bleeding when the stool is already black. So all in all, I found that iron is not absorbed for various reasons, it has side effects, and I do not need the oral iron. I can give more IV, particularly when you label the 200.
(Back to question index) What type of iron therapy do you recommend for a patient who is very sensitive to IV iron, the patient is allergic to every IV iron on the market?
Dr. Reed : I have actually looked at those patients in our own practice some years ago when we only had iron dextran available. As the newer agents came out, as I mentioned, there is an ongoing group of probably over 100 patients found that have been able to tolerate iron sucrose but could not tolerate the others. At the end of the day, it is rate of IV iron infused and amount. The body simply cannot take up IV iron that quickly, and this anaphylactoid reaction is due to that transient excess iron.
(Back to question index) Here is a financial question. Some hospitals and corporations set up best practices for early diabetes and so forth in the years past. Many have closed because of expense, lack of profit. Is there a financial incentive for a primary care provider to support CKD clinics?
Dr. Reed : That is good question. I tell you we have made it work. I will tell you I used to sell cards, Christmas cards, and all sorts of things, and we have a small crew of people who work with us. We have been able to maintain a lower overhead. We are not so interested in making money with CKD, but if you can put that with your hemo population from a physician standpoint or nephrology office practice perspective, if you bring people to dialysis who are well, they are with you much longer. You have to put it all together. There is the profit there and certainly in our case, we have passion for this work, and we know it is the right thing to do. I think that is what drives us. But, in answer to the question more directly, no we have not lost a bunch. For instance, we see these patients once every 3 months and we get reimbursed for the visit, for the infusion, and all the fees that go with it. If you have got so many CKD patients, they could go on hemo, and I will be glad to share that if somebody wants to know in detail.
One other issue that I am working on is, I have become a lobbyist, among other things, late in my career, and I am working very passionately with the legislature. I have been to Washington a couple of times, and we are lobbying for more support to this group of people. Take this variable out of the question, just take it out of the formula - the people need care. They are largely an underserved group. There are all sorts of problems with them. Yes, we could use the added support in our office. Our RN functions as my social worker as well. I think that this will come to pass, maybe not in my career but we are collecting data now to prove our work, and we can prove in any way you want to look at it, if we get to see the predialysis patient over a period of time, the billions of dollars spent on access, the billions spent on hospitalization are saved, and we would hope to be there at some time in our future.
That is a very good question, and I think that if you make the commitment, you can make this work. I will be glad to talk to anybody or a doctor who wants to call me, I am available. We have done followup through nephrologists on this issue of how do you make it possible. Even standing alone, there is a plus sign at the bottom of the numbers, but when you put it with your total picture, there is no question - it is the right thing to do.
(Back to question index) There are a couple of questions here about pediatrics, and I am sorry we did not have any children in our study. We simply just do not work with children. There is a question whether or not we feel that our children are also at greater risk of death with anemia then progressing to ESRD.
Ms. Copeland : I would just say that they would also have anemia, then be progressing, but I do not have any actual statistics on that, so I apologize.
(Back to question index) For PD patients, do you use the same rate of IV irion administration in your practice?
Dr. Reed : First, we have to label for the use in the nondialysis group, which is basically not the CAPD patient. There is a label for that, and we have done studies in our hemo population. Since you asked the question, I can answer it. We are very comfortable with both hemo and PD and for 3 years now, we have been giving the 5-minute push of 200 mg for PD, and we do have a more clearcut algorithm on how to give that. In fact, we draw the blood out of the needle based on the iron studies of the previous month since access is a problem in a lot of these people. We will take a blood sample and push the iron through the same needle and try to limit venipuncture as much as possible. Admittedly, we are running a little late there. We will try to give iron. When we first started this with infusion, the PD nurses wanted to kill me in their clinic because I was ordering iron based on the lab 3 days ago and giving the push now is much less problematic, but I have agreed that the local patients who are not out of town, can come in another day, just to keep the clinic running. For rural America, I think, for those who come in many hours to the clinic, I would consider infusion. I think the question was do I change it any, and I do not.
There is a study that is coming out very soon that will prove the PD, and I have one already that I could show you. This is one that has been done that looked at 126 PD patients who were all on EPO, and they were given IV iron infusion as opposed to push, and they did very well, with remarkable improvement in serum hemoglobin, for example, 59% had a rise greater than 1 g/dL. We feel the same way about oral iron in PD patients - I know there are PD patients who can be made to take oral iron, but it's not that many.
Thank you for your questions. We enjoyed it very much.
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