Patients Feel that Appropriate Hemoglobin Levels are Vital to Quality of Life

[okarol]

Patients with Kidney Disease Feel that Appropriate Hemoglobin Levels are Vital to Ensure a Good Quality of Life

GLENDALE, CA—Patients with chronic kidney disease (CKD) typically suffer from debilitating anemia that is characterized by low hemoglobin levels, fatigue, and a poor quality of life. Severe anemia may also necessitate blood transfusions, which can limit the options for future kidney transplantation. Testifying in front of a joint committee of the Food and Drug Administration (FDA), Lori Hartwell, founder and president of the Renal Support Network, provided compelling first-hand insights on why appropriate anemia management is vital to the quality of life of patients with CKD.

The FDAs joint Advisory Committee, composed of members from the Cardiovascular and Renal Drugs and Risk Management Advisory Committees, was convened to discuss the use of erythropoiesis stimulating agents (ESAs) and target hemoglobin levels in patients with chronic kidney disease (CKD). ESAs have been used to treat anemia in patients with CKD for almost 20 years.  For the past 10 years, the typical target hemoglobin level for patients with CKD has been approximately 11 to 12 g/dL. Recent clinical trials in patients with CKD or cancer revealed potential safety concerns when hemoglobin was targeted to exceed the 11 to 12 g/dL threshold (for example, 13 g/dL or above). As a result of these data, the FDA Advisory Committee debated whether hemoglobin targets for patients with CKD should be decreased to 10 or 11 g/dL

Testifying on behalf of patients, Ms. Hartwell asked the committee to consider both the risks and benefits of ESA therapy and appropriate hemoglobin levels. “I am not downplaying the safety risks of the trials that have been published,” stated Ms. Hartwell. “All drugs carry risks, and patients deal with these risks every day in every facet of medicine. However, patients are also acutely aware that the potential risks associated with drug therapy need to be weighed against the benefits.”

Ms. Hartwell explained why the hemoglobin target of 11 to 12 g/dL currently recommended by the
National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative helps improve the quality of life for patients with CKD. “Many studies have shown that treatment outcomes and quality of life suffer when hemoglobin levels fall below 11.0 g/dl, and my own experience confirms these data,” Hartwell stated. “ At a hemoglobin at 11 g/dL I can feel the difference. Daily activities become difficult or impossible to perform.  Shortness of breath and fatigue are constant reminders that I am chronically anemic.” 

Ms. Hartwell went on to read a sampling of quotes from other patients to emphasize the impact of anemia on patient quality of life. “I urge the committee to consider how the quality of kidney patient’s life will suffer if your decision forces us to ignore twenty years of progress and regress to hemoglobin levels where it is near impossible for us to remain productive citizens,” she stated. “I would contend that regaining our quality of life is as important as preserving our lives.”

Hartwell also discussed the increased risk for blood transfusions in patients with lower hemoglobin levels. Before ESA therapy was available, about 16% of patients on hemodialysis required a blood transfusion each quarter of the year. That pattern has changed significantly since the advent of ESA therapy, and currently less than one-half percent of patients on hemodialysis require blood transfusions. Hartwell pointed out that, “Blood transfusions can have a significant and long-lasting negative impact on our health and even increase our risk for death.  Blood transfusions can severely affect a patient’s ability to receive a kidney transplant.  The reactive antibodies received from blood transfusions result in fewer potential kidney matches from donors…As a result of blood transfusions, the number of potential kidney donors that are a compatible match is severely limited.”

In closing her testimony, Hartwell asked the committee to consider the patients perspective, and include an assessment of the impact of their decision on patient quality life.  She stated,  “Quality of life is measurable.  Patients measure it every day.” 

On the basis of the testimonies provided by clinical and technical experts from the nephrology community, as well as Ms. Hartwell, the FDA’s Advisory Committee recommended a hemoglobin target range of 10 to 12 g/dL for patients with CKD. Additional recommendations regarding ESA dosing recommendations and how to identify patients who exhibit hyporesponse to ESA therapy are forthcoming.
 


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(September 13, 2007)

 Renal Support Network
(866) 903-1728 Ext. 105
heidi@rsnhope.org

[paris]

Thanks Karol for this article.  This is what I have been going through at my nephs office.  When my hemoglobin was 13 or 13.5 I felt so much better. More energy, just overall better.  Last year, that was werer they were trying to keep my levels.  Now they are keeping it at 11.5 or so. Under 11 and they adjust my dosage .  I hate it and would love to be at 13 again. It made such a difference.   It is always something, isn't it?  Thanks for working so hard for all of us at IHD

[paddbear0000]

 “Many studies have shown that treatment outcomes and quality of life suffer when hemoglobin levels fall below 11.0 g/dl, and my own experience confirms these data,” Hartwell stated. “ At a hemoglobin at 11 g/dL I can feel the difference. Daily activities become difficult or impossible to perform.  Shortness of breath and fatigue are constant reminders that I am chronically anemic.” ....

....Blood transfusions can severely affect a patient’s ability to receive a kidney transplant. 

  I HATE my f**king doctor!!! My hemoglobin is at 10.7! What is he waiting for?! Me to be bedridden because I can no longer walk 2 feet?!!! I'd also like a new, functioning kidney some day!

 

[Black]

OMG!  10.7    That's awful.  Give them hell until they do something!