Hemoglobin protocols

[fearless]

M3Riddler,

I probably never should have made this post.  I just want people to know that their doctors are still in control of their hemoglobin, because my doc had led me to believe that it was impossible for her not to cut me off at 11.  I'm very familiar with how the drug works as I've been completely dependent on it for a dozen years.  Not everyone on dialysis needs epogen consistently as I do.  When the practice was to simply increase or decrease the dose to keep me between 10-12 my hemoglobin was typically just above or below 11, sometimes dropping below 10.5, but never going above 12.  That's because my kidneys haven't been making erythropoetin for a very long time.  Then, when the practice of holding the drug completely if hg went above 11 started, my hemoglobin dropped off quickly and then took 3 weeks to climb back up (and if they check hg in the meantime it means they increase my dose, so then it goes too high and they cut me off again)  So, I'm on a see-saw, which research shows is more unhealthy than a stable hg at 10 or 11. 

I'm tired of people saying I should be OK at 9 or 10 because "people adjust".  I lived for a number of years at 10, 9, 8, and finally 4.  But that was before I started dialysis.  I've been on dialysis for 9 years and there's no "adjusting" left in my body.  Also, being on hemo means instances where you lose some blood, draw labs, etc.  I think it's important to have a doc that will work with me to try to maintain a level of quality of life.  If I'm too tired to do much outside of my dialysis, what's the point?

If you look at the research on the FDA page I don't think you'll find any support for keeping people ON DIALYSIS below 11.  Two of the three studies were done on patients who are not on dialysis.  The ESA's were competing with the patient's own body's ability to still produce erythropoeitin.  This is the same reason why athlete's who use epogen to pump up their Hg can suffer negative consequences.  I understand that caution is required, but I think it's cruel to say that dialysis patients should be left without epogen until their Hg drops so low that they would otherwise need a transfusion.  Maybe for starting patients who are still producing erythropoetin and can maintain a certain level without the drug that's acceptable.  But for me, I'm more interested in trying to live some sort of life while these years hooked to a machine pass.

The FDA can't tell doctors what to do.  But my doctor hasn't really been straight with me.  I've just been accepted by another doctor and clinic where it sounds like they'll help me to try to stabilize my hemoglobin somewhere around 11.   For me that means not cutting off the epogen when my Hg is 11.2, but rather adjusting the dose down a little so that I don't then need big doses to get up again.  To people who say I shouldn't need to be at 11, all I can say is: you don't have my history, you're not in my body, so you might want to think about simply supporting the right of a patient and doctor to work out what's best for each patient.  Do you really want to have the government restricting your doctor's ability to try to help you?  What about when all you can hope for out of life is simply some ability to perform the simply tasks of caring for yourself?  Let alone trying to work to pay for your own medical care.  If someone who's been on D for 9 years while at the same time has had a Hg below 7 and even 4 for 12 years wants to tell me I shouldn't want this for myself, then i will be more inclined to listen.  (but maybe not really, because research also shows that chronic anemia with a Hg of 10 or less also has its own risks)

This is also about Fresenius trying to save money.  If the quality of care standards are still 10-12, then there's no reason for my doc to try to make me think that there's some national restriction on prescribing an upper limit of say 11.5.  She's trying to go along with what the clinic wants her to do.  If she wants to do that it's fine, but I feel like I should know that that's what's going on.   I asked her how she felt as a doctor being told how she could prescribe medicine and she said "nobody likes it"  I asked her what I could do to help change the situation and she said "Write your congressmen".  When I asked her what I should say, she could never tell me.  I now realize it's because nothing's really changed in the way she's allowed to prescribe - what's changed is Fresenius policy - and my doc apparently doesn't want to have any of her patients outside what Fresenius wants.
I tend to get angry when somebody somewhere just doesn't want their own inflow of cash to suffer and is willing to sacrifice my ability to live a life in which I can find even a simple pleasure here and there, or just the satisfaction of being able to clean my apartment on my day off the machine.  or carry a bag of groceries up the stairs and not have to sit on the floor for 5 minutes until I can carry up the next bag.  And having that be it for the day.

When I started dialsyis, and even 2 years into it, I was still quite physically active.  I remember shoveling the driveway and traveling for my job and carrying my Baxter machine up flights of stairs in a hotel.  But those days are gone.  It is perhaps declining overall health that makes the Hg issue more important to me.  i don't like it that epogen is a risky drug.  I don't like it that doing dialysis itself is risky.  I'm just trying to keep it together emotionally and mentally so that I can keep living as long as I keep living.

The FDA is invaluable to our health and safety.  I'm glad they've taken note of the risks of ESA's.  There is a population of patients who need to be kept OFF these drugs.  They're mostly cancer patients and pre-dialysis kidney patients.  They're not people like me who have been dependent on the drug long-term to maintain a quality of life. 

people may be interested in what the UK guidelines are:
http://www.kidney.org.uk/Medical-Info/other/know_nos.html

my doc said that the 11 cut off was international!!! (it's not even national to US)
Maybe you can begin to understand my anger.  It's just as much about being misled by my doc for 5 months as it is having to feel like crap.

I think that people here are concerned that I might be trying to do something that would actually not be a healthy thing to do.  But I'm going to just trust my new doc to work within the 10-12 range to try to get me stable at the lowest point from which I can still meet the physical requirements of my life.

Part of my motivation for saying something about Fresenius cutting people off at eleven and not starting them up again until they fall below 10 (which means they're going to spend time at even lower levels if they're like me) is that I've done D in-clinic, and I've seen what the majority of patients there were like.  They obviously felt like shit most of the time, but some of them seemed to be doing ok.  They are older people as a rule, and I doubt that they are very involved with their labs and meds.  They're not going to know why they feel worse than they did before, and they're not going to know why they don't feel like having their grandkids visit, etc.   They're already old, they're probably going to die of complications of CKD and dialysis, but they're going to be prevented from feeling as well as they possibly can due to ineffectively-treated anemia.

...and lastly...for those who think there's no "revolving door" between government regulatory agencies and private industry, you may find this interesting:
http://www.cptech.org/ip/health/politics/revolvingdoor.html

thanks M3Riddler.  I always appreciate anything you're willing to share with me because I know that you have long-term experience.  Did you read my later posts on this thread?  I don't want a hemoglobin above 12.  I just don't want to get cut off at 11 and left to keep falling until I'm at 9.7, 9.5, etc.  Do you use an esa?  How many years? What is your current hemoglobin and how long has it been there?  Were you very anemic when you started D?  Research shows that men who aren't anemic when they start D often don't need an esa for a long time. 

This is from the U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES:
"The U.S. Food and Drug Administration (FDA) recommends that patients treated with EPO therapy should achieve a target hemoglobin between 10 and 12 grams per deciliter (g/dL).
People who take EPO shots should have regular tests to monitor their hemoglobin. If it climbs above 12 g/dL, their doctor should prescribe a lower dose of EPO."

it doesn't say anything about cutting off the dose at 11

and from Wolters Kluwer:
"Anemia has emerged as an important, independent risk factor for the development and progression of LVH and HF in CKD, and of adverse cardiovascular outcomes, including mortality"
http://kidney.niddk.nih.gov/kudiseases/pubs/anemia/#points
and
"The target Hgb or Hct levels for patients treated with ESAs are the subject of regulation by the FDA and health-care payers, quality assurance programs in dialysis units, and clinical practice guideline recommendations. Ideally, the target Hgb or Hct in patients with CKD, including end-stage renal disease (ESRD), treated with any erythropoietic agent would be defined as that value that is clinically optimal for each patient, based upon their special circumstances, such as general level of function and employment, and comorbidities, such as ischemic coronary disease and heart failure."

so, the clinics can set low limits if they want to, but it's not necessarily the best level for ALL  patients.

[fearless]

and, just to really overdo it:
this study shows why dosing should be diiferent for ckd on dialysis vs not on dialysis, and why anemia is just as bad as keeping Hg artificially high (and for those of you who aren't familiar with the abbreviations, Hct is hematocrit, which is a count of the RBCs and is another indicator of anemia.

Target Hemoglobin/Hematocrit for Epoetin Therapy

The target range for hemoglobin (hematocrit) should be Hgb 11 g/dL (33%) to Hgb 12 g/dL (36%). (Evidence) This target is for Epoetin therapy and is not an indication for blood transfusion therapy. (Opinion)

Rationale   A Hgb of 11 g/dL (Hct 33%) is at the lower limit of the normal range for pre-menopausal females and pre-pubertal patients; a Hgb of 12 g/dL (Hct 36%) is just below the lower limit of the normal range for adult males and post-menopausal females (see Guideline 1: When to Initiate the Work-up of Anemia). Because the anemia literature in CKD patients does not distinguish between sexes, subsequent Hgb/Hct levels will apply to both males and females.

There are several pieces of evidence suggesting that patient outcomes are worse when the Hgb is ñ10 g/dL (Hct ñ30%):

1. Survival of dialysis patients declines as the Hct decreases below a range of 30% to 33%.25,81 Survival was also shorter in dialysis patients with chronic glomerulonephritis whose mean Hgb level was 9.9 g/dL, compared to patients with polycystic kidney disease whose mean Hgb level was 11.3 g/dL.82 Whereas one study failed to note any improved survival at a Hgb >11 g/dL compared to an Hgb 10 to 11 g/dL,83 several other reports have shown improved survival at higher Hgb/Hct levels. Survival was improved in Italian hemodialysis patients when the Hct exceeded 32%, either spontaneously or following Epoetin therapy, when compared to Hct <32%,84 and in the United States an Hct of 33% to 36% reduced the risk of death from any cause by 10% when compared to patients whose mean Hct was 30% to 33%.85 Survival has been noted in one study to be better in patients with cardiac disease who attained and maintained a normal Hct compared to similar patients who did not attain and maintain a normal Hct.80 In fact, within both the normal Hct group and the control group, the mortality decreased at higher Hct levels.80 In those 200 patients who achieved and maintained a normal Hct for 6 months, mortality decreased to approximately 15% per year, versus 40% per year in those maintained at an Hct of 30%. There were no convincing factors that appeared to explain why those patients that did not achieve and stabilize at a normal Hct had a greater incidence of non-fatal myocardial infarctions or death than did the control group.80

2. Left ventricular hypertrophy (LVH) is more likely in CKD patients with anemia (Hct ñ33%)86-88 and in patients with ESRD89; in such patients the risk of death is increased 2.9-fold (Endnote c).90 Partial correction of anemia (Hgb 6.3 ± 0.8 to 11.4 ± 1.5 g/dL) with Epoetin resulted in partial regression of LVH in dialysis-dependent patients.91 Angina was significantly decreased in patients with progressive CKD when Epoetin therapy increased the Hct to 31% ± 4% versus 23% ± 4%.92

3. Quality of life either is not improved, or improved only slightly, when the Hgb/Hct is increased from 8 g/dL/25% to a level no higher than 9 to 10 g/dL/28% to 30%.93-95 However, quality of life of dialysis patients, as assessed by standardized patient questionnaires, increases as the Hgb/Hct increases above 10 to >12 g/dL and 30% to >36%.96-98 When the results of the Amgen Phase III (mean Hct 35%) and Phase IV (mean Hct 30%) studies were compared, it was concluded that patients with Hct levels of 35% had better quality of life as measured by Karnofsky scores than those maintained at a Hct of 30%.99 Both quality of life and various physiological parameters in predialysis patients have been shown to be significantly better at a Hct of 36% to 39% than at 27% to 29%.100-107

4. In hemodialysis patients, exercise capacity (VO2) increased when the Hct increased from 30% to 35% to 40%.108

5. In hemodialysis patients, the incidence of hospitalization was lower when the Hct was 33% to 36% in comparison to patients with lower Hct values.109

6. There are a number of studies in dialysis patients (reported initially only in abstracts) that indicate that quality of life, maximum exercise capacity, number of meters walked in 6 minutes, cardiac output, cognitive function, amino acid levels, sleep dysfunction with daytime sleepiness, insulin resistance with hyperlipidemia, and survival improved when a normal Hct was achieved,76-78,110-118 and that there were no adverse effects observed at a normal Hct.110,111 Several of these studies have now been published in peer review journals, and demonstrate that a normal Hgb/Hct is associated with better physical performance,79 better cognitive function,119 improved brain oxygen supply,120 and improved sleep patterns121 compared to lower Hgb/Hct levels.

[fearless]

if someone you love is on dialysis, or if you are and you can't take a walk now and then due to anemia (instead of some other problem like heart failure) or if you have CKD and you're not on dialysis yet, this issue should concern you.  If you're being taken care of by a for-profit health provider your esa may be restricted beyond what might be medically best for you simply because the company isn't being reimbursed as before and the black box warning on the drug provides an excuse to cut.

You should try to manage with the lowest possible dose that allows for exercise tolerance.  And keep in mind that for patients on dialysis anemia increases the risk or LVH.  Also "see-sawing" of Hg levels as opposed to a maintenance dose carries its own risks (can't find that link sorry)

The news about these esa studies is not being interpreted properly for patients and the public.  The popular understanding seems to be that less is more.  But that isn't completely true.  Sometimes when you repeat something enough people think it's true.  You should care about this issue because you may find yourself in a position where the risk of a higher dose of an esa would outweigh the risk of a chronically-low Hg.

OK, I'm done lecturing everybody 

[JasonEb]

I would like to add that my experiences with epo have been very similar to fearless' over the years.  The protocol at the unit I was at would give doses of epo until my Hgb would reach 12, then cut it off until it plummeted down to once as low as 6 before starting it up again, since they would only check the Hgb levels monthly.  I, also, would begin to feel like I was pushing through sludge once my Hgb got below 11.  My neph had prescribed my Hgb to be at (or around) 12, but everytime it hit 12, BAM!, the unit would cut it off.  He would then write an order for them not to cut off the epo, but after six months or so, that order would get buried in the billion pages of orders that they write and some new nurse who was in charge of meds wouldn't know it was there and BAM! cut me off again.  Occasionally I would catch it pretty quick, noting that I wasn't getting the epo each treatment, sometime it would slip past me for awhile.  Eventually I would catch it, tell whoever needed to be told, they'd call the doctor, he'd rewrite the order, rinse and repeat.

When this happened the most recent time, a(n awesome) nurse asked my neph to write an order to take me off the protocol which automatically cuts the ordering of epo off when it reaches 12, but will instead lower the dose in order to perhaps keep my Hgb in the mid-11's.  Worked so far, but we'll see what happens when that order drifts to the back pages.

Now, people cite the dangers of higher Hgb, but I've always held this philosophy:  I would rather live 10 years actually being able to function (relatively) like a human being, than spend 20 years just existing.  That seems to be the goal of the business and government regulated side of this industry.  They only care if we exist, not thrive.  There seems to be very little consideration given to the quality of life a dialysis patient has, merely the quantity.

[MightyMike]

My clinic is the same they won't go past 10.5 because of chances of blood clots and strokes.  Mine drops down to the 8's and it takes them months to get back up to around 10.5 which I still feel exhausted.  Then they stop it and eventually it drops back down into the 8's again and so the cycle repeats.  I read one of my bills once and it said EPO cost around $1,200 for one dose.  That in my opinion is ridiculous.  I did better with procrit and aeronesp when I was administering it myself.

[fearless]

Please be sure to communicate to your neph and social worker if you are feeling overwhelmed by being tired. 
The social workers at Fresenius are trying to address this with their "Quality of Life" surveys because a lot of patients are complaining about the new restrictions.
I don't think there's any research that shows it's good to see-saw between 8 and 10.5.  The seesawing is bad enough, but when you're spending a lot of time that low there may be other complications besides clots or strokes.
Hope you can get some help.
My doc said that Fresenius is doing its own research to see what's what.  Are they doing that by letting people drop too low?  It's much harder to be at 8 when you're on dialysis than when you're pre-D.  I can say that from experience, and maybe you can too depending on what point you were at when you started D.
I hope we patients can get together on this and speak with a united voice.  Those who don't find this to be a problem now may very well find it to be a problem in their future if they end up on dialysis for very long.
I used to shovel the driveway and mow the lawn after I got on D, and my hemoglobin wasn't any better than it is now.  And my iron is actually better now.  I think it's just that your body gets worn out in many different ways.  Anyway.  My clinic cuts me off and then gives me big doses because I drop down and when they check it again after they start the dose back up it's still low, so they increase the dose.  This time I shot up quick and I have noticed a higher blood pressure, so I'm hoping that comes down as the blood count drops.  It's really crazy. 
I hope my new clinic will work with me to try to get it stable.
I honestly hope you can get some help to improve your situation as well.

[lmunchkin]

John is like Grumpy, he seems to function better at 12.  The perameters the clinic use is 10.0 to11.0  Last month J was 12.3 and this month he was 12.2.  He seems to be just fine and no epo for now. More importantly, his iron levels are normal!

God Bless,
lmunchkin

[Fatkidney]

This is all so interesting.  I'm pre-D.  Have only been on epo shots since January.  Like others my doc stops them if my hgb goes above 12.  He cited the cardiac risk for this.  But I get a shot if my number is below 11.  I'm checked once a month. Number is usually around 10 by then.  I'm feeling pretty crappy by that point.  I feel like I can tell when it goes below 11, because of how tired I get.   You guys who are down in the single digits.  I can't even imagine. 

As for the money, yes the shots are uber expensive. My doc had to go through a laundry list of things to make sure they weren't causing my low hgb before he would let me have the epo because the insurance companies are apparently very touchy about epo.  A nurse friend calls it liquid gold.

[wvgirl]

I started dialysis in center hemo in May but have been on epo for a few years. I started feeling tired just folding laundry about 7 years ago!! Hb was around 10.5. It stayed between 10-11 for 5 years untill dropping to 8 suddenly, which is when I started injections. At 8, I was so pale, that even my gums were pure white!!  I felt great at 12, but any lower than 11 and I could tell a big difference. Now on d, it went to 11.2 about 6 weeks ago. I didn't even realize that they had stopped it, but started getting that familiar tired feeling. Found out when I got my labs it was 10.2 and they started the epo again. After 3 weeks, now it is 10.3. I didn't realize there was this protocol now. Also, I think just like everything else with this disease everyone seems to be different in their symptoms. I know, when I was at 8, even friends noticed how I looked, and the fact I had a winter coat on in warm weather. I was so so cold!! I want to be at least 11, but prefer closer to 12.

[Grumpy-1]

they are finally starting to listen to me.  I've been put on a weekly shot of EPO (low dose) just to maintain instead of the roller coaster effect of high then low then high then low.  I hope they will continue this method.  Grumpy

[Joe]

I'm working with them to figure out where the maintenance should be. I was down to 10k units a week, but that brought my Hemoglobin count up to 14, made them a bit cautious. Have been holding for two weeks and taking an H&H lab every week to see when it gets down. Geez, it would be nice to not have to bother with this stuff anymore.

[amanda100wilson]

why can we not be partner in our care?  tell us the benefits and risks, and not just from high epo doses but also the risks of having a low Hb, and let US be involved,in the decision-making process.  As an individual, If I feel like crap the whole time because of a low Hb, as long as I know the risks and my consent is documented, why can I not elect to take the risk of taking more Epo?  When my Hb is lower I get palpitations and I can feel my poor old heart working overtime ?  sure as hell that ain't good for me either.  however that is ok because At least I am costing less.

[Grumpy-1]

I agree Amanda.  I'm lucky in that the nurses at the clinic do listen to me and understand that I know my body and how I feel better than anyone else.  Of the 5 nephs, 2 listen and will discuss with me options, concerns, and even treatments.  The other 3 (and I try to avoid) give the sense of "I know more than you".  Sorry Charlie, I know what I'm feeling and sometimes it doesn't match the text books.  I have no problems TRYING to interject my comments into conversations with the Dr and nurses.  I've learned a lot here and don't mind giving others my opinions and feelings.  At the first, I didn't just let the Dr and everyone tell me what they thought I should know.  NOT NOW!!!  I'm in the game and calling the shots.  Grumpy