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CG114 Anaemia management in CKD (update) Podcast with Dr Paul Stevens

Dr Paul Stevens, Consultant Nephrologist and Associate Medical Director from Kent and Canterbury Hospital and  clinical adviser for the Anaemia management in CKD guideline discusses implementation of the updated recommendations in clinical practice.

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This podcast was added on 9 Feb 2011

Podcast transcript

Podcast with Dr Paul Stevens: NICE clinical guideline CG114 on Anaemia management in chronic kidney disease (update)

Interviewer: Thank you for choosing the podcast on the updated guideline Anaemia management in chronic kidney disease, for short we will be referring to chronic kidney disease as CKD. This podcast will focus on the updated recommendations for clinical practice.

I am Mandy Harling the Implementation Adviser for this guidance and with me is Dr Paul Stevens, Consultant Nephrologist and Associate Medical Director from Kent and Canterbury Hospital. Paul is a clinical adviser for the guideline development group for the original and updated Anaemia in CKD guidelines and a co-chair of the development group for the NICE CKD quality standard. Paul was also a clinical adviser for the NICE guideline on CKD.

Q1 Interviewer: So Paul, could you explain why this guideline has been updated?

P.S: Yes, at the time of publication of the original guidance we were aware that there were two large randomised control trials in anaemia management in chronic kidney disease that were going to be published. One of them generated a fair amount of discussion that was a trial predominantly from the States called CHOIR which used a lot higher doses of erythropoiesis stimulating agents than the other large trial. And there was a question raised about patient safety with achieving higher levels of haemoglobin in that trial. Sufficiently in fact for the US FDA organisation to issue what is called a black box warning and subsequently our European Medicines Agency and our own medicines health regulatory authority issued a similar warning about treating people with anaemia to too high haemoglobin levels.

Since then there has been a third and the biggest randomised control trial in anaemia management in chronic kidney disease to date published that also raised some concerns for patient safety, with people driven up to higher haemoglobin levels. So we wanted to go back and look at the recommended aspirational ranges for treatment. Partly to assess whether or not we should be changing the original recommendation, but also because there was a very real concern amongst clinicians who spanned the time before erythropoiesis stimulating agents were introduced and afterwards. Because before this sort of treatment was available to us we had a population of people on dialysis with anaemia who had haemoglobin levels of about 5 to 6 grams per decilitre. They were heavily iron overloaded, so much so that far from iron supplementation that we do these days we were having to undertake strategies to remove excess iron from their bodies. So the key thing in my lifetime in kidney disease which has changed has been anaemia management and symptom control and we were quite keen that the benefits that have been achieved in the years since the introduction of erythropoiesis stimulating agents weren’t lost.

Q2 Interviewer: Advice on the diagnostic assessment of anaemia has now changed. What do clinicians need to be aware of regarding these changes?

P.S: The changes are not huge, the actual level of haemoglobin at which people should start considering working someone up for anaemia management hasn’t changed for example, so that’s still 11 grams per decilitre. But the change is to perhaps to try and get people more aware of the kinetics of the situation. In other words when we are talking about people falling what we are doing is talking about people who are falling to a level of haemoglobin below 11 grams per decilitre who are quite clearly going to continue to have a falling haemoglobin unless there is an intervention.

And we are also quite keen to particularly draw people’s attention to  those patients who actually had symptoms from their anaemia, in other words were clearly having problems caused by the anaemia itself as opposed to just being coincidental.

Q3 Interviewer: How have recommendations on the treatment range for haemoglobin altered in the updated guideline?  

P.S: The updated aspirational range and I use the word aspirational perhaps slightly advisedly because when we are talking about treatment ranges and in particular when we are talking about targets - targets are something that we aim at – what we are trying to do with correction of anaemia in people with kidney disease is to aspire to get them within a certain range of haemoglobin. So the original range was 10.5 to 12.5 and that’s just been readjusted slightly down to between 10 and 12 grams per decilitre. The same recommendations in terms of how you would react to a haemoglobin level that is changing are there in the update as were in the original guidance, so in other words, don’t wait until someone gets outside the aspirational treatment range before you start adjusting treatment.

The other key change is not so much in terms of the actual aspirational range that is recommended, but to get people to apply them to people as individuals rather than as a one size fits all. For example a young physically active person who will respond very easily to anaemia therapy and actually does a lot better with a haemoglobin level which may be above the upper limit of the target range. There may equally be people who are not responding to anaemia therapy in whom you would accept a lower level of haemoglobin because driving the haemoglobin up to higher levels, a, is not going to be successful and b, is going to expose those patients to high doses of erythropoiesis stimulating agents and potentially to harm as a result of that.

Q4 Interviewer: So what may this mean for clinical practice?   

P.S: The main thing is to be aware that using high doses of erythropoiesis stimulating agents may not be in the best interests of the patient. The realisation that driving people to try and achieve a haemoglobin level when they are clearly not able to respond to it is certainly not cost effective, and may well expose a patient to harm.

Within the updated guidance we have put in a footnote that gives some guidance to people about what a high dose of erythropoiesis stimulating agent might be for someone on haemodialysis, for someone on peritoneal dialysis and for someone who is not on dialysis. And those doses are largely derived from current UK clinical practice, so they are pertinent to our own county’s practice. 

Q5 Interviewer: What do clinicians need to be aware of when initiating or escalating ESA therapies?

P.S: The key thing is what you do before you actually start the erythropoiesis stimulating agent or before you think about changing the dose and the biggest area there is always going to be about optimising iron status. What we were able to do was emphasise that optimising iron status before starting an erythropoiesis stimulating agent and making sure that in maintenance therapy that iron status remains optimised is certainly a key thing in anaemia management.

Q6 Interviewer:How does this reflect on current clinical practice?

P.S: The useful thing that has happened at the same time as the NICE guidance being updated is that Renal Association clinical practice guidelines on anaemia management have been updated at the same time.

And the ranges that are recommended in the NICE guidance are also the same ranges that are recommended in the Renal Association clinical practice guidelines.

Q7 Interviewer:The benefits of engaging patients with their treatment plans are well recognised. How could these changes be best explained to patients?

P.S: As with any other form of patient management, it is important to explain to an individual patient what it is that is wrong with them and why you want to introduce a treatment that is aimed at improving things. The way that anaemia management has changed for patients who are already on anaemia therapy also needs to be explained to them and the reasons behind why in particular why we changed the treatment range to drop it down a little bit needs to be explained. There is no additional benefit to be gained from raising the haemoglobin levels above 12grams per decilitre and we know now from the latest trial data that there is potential harm in pushing haemoglobin levels above that level, particularly if   in order to get there you need to give very high doses of erythropoiesis stimulating agents.

Q8 Interviewer:Who are the likely population to be affected by anaemia in CKD?

P.S: All people with kidney disease who are dialysis dependent will require some form of anaemia management. And in by far the majority of those this will be with both intravenous iron and erythropoiesis stimulating agents, although there is a small proportion of people on dialysis, particularly peritoneal dialysis who may get away with just intravenous iron alone.  People in stage 3a and stage 3b chronic kidney disease would be unlikely to have anaemia associated with chronic kidney disease and much more likely that their anaemia would be due to something else. Having said that certain treatment groups tend to develop anaemia at higher levels of kidney function, and people with diabetes in particular will tend to develop anaemia at a higher level of glomerular filtration rate than people without diabetes.   

Interviewer: Thank you very much Paul. We hope that you have enjoyed this podcast and found the information useful and that it will help you when putting the guidance in practice. For more information about the updated Anaemia in chronic kidney disease guidance and for access to the implementation tools please visit the NICE website. 

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.