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3505 E. Frontage Rd.
Suite 315
Tampa, FL 33607
800-749-2257 phone
813-636-8122 fax
info@aakp.org
August 2007

Recently, AAKP testified before Congress regarding quality initiatives for kidney patients. In the testimony, one of the discussion items centered on the use of erythropoietin stimulating agents (ESA) or as formally known - EPO.

Due to current research regarding the safety of ESA usage in patients at higher levels, AAKP supported achieving a hemoglobin level of 11-12 grams per deciliter as indicated by the FDA label. AAKP believes, because of current literature, that patients should not remain at levels above 13 grams. However, AAKP testified that it adheres strongly to the principle that a physician and patient must be permitted to decide a care plan best suited for that patient. We emphasized that under dosing of ESAs is also a danger, as patients should not suffer the debilitating fatigue associated with anemia. AAKP certainly does not want to scare patients away from being treated with this valuable life-enhancing medication.

We also cited an AAKP survey done in 1997 regarding the then released National Kidney Foundation Dialysis Outcomes Quality Initiative. (NKF-DOQI). In the testimony we cited results that patients are willing to have subcutaneous administration of ESAs. Why did we provide this information? When the NKF Anemia Workgroup did their original review of more than 40 studies of 2,000 patients, it was found that only two thirds of the subcutaneous dose of EPO is required to produce the same outcomes as by intravenous. The reason is the drug is absorbed into the system slower and therefore has a more prolonged effect to stimulate the bone marrow to produce red blood cells.

AAKP has re-released the executive summary of the original patient survey in light of current ESA discussions. The summary can be found by clicking here. The survey included not only use of ESAs, but also vascular access placement, administration of iron and increase in dialysis prescription time. The study was designed, pilot tested and fielded in a self-administered mailed survey to 3,600 patients. Covance Health Economics and Outcomes Services, Inc. provided survey assistance and performed all data analysis. The survey was funded by Amgen.

Interestingly, findings included that 94 percent of the respondents felt it was "very" or "extremely" important that the doctor make the decision based on "how EPO works best for me." Furthermore, when asked their view on how important pain of receiving EPO was to their decision, 61 percent felt that there was "no," "little" or "neutral" importance to how painful it was to receive the medication subcutaneously.

An important finding of the survey was that at the time, 98 percent of peritoneal dialysis patients were already receiving their EPO subcutaneous, while only eight percent of hemodialysis patients received subcutaneous injections.

What does all this mean? AAKP most certainly is not endorsing a one size fits all type of treatment. However, it is important to talk to your physician about all of your treatment options, whether it is dialysis modality choice, medications or any other treatment matter. There are pros and cons to every decision and when armed with all the information, a patient can certainly be the leader of his healthcare.

Regards,

Kris Robinson
Kris Robinson
Executive Director/CEO


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