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New York, NY
August 30, 2007
After an extensive review of results from six new randomized controlled trials comparing risks and benefits of a range of target hemoglobins (Hb) in chronic kidney disease (CKD) patients, a National Kidney Foundation Kidney Disease Outcomes Quality InitiativeTM (KDOQITM) work group is today issuing an official update of its 2006 Clinical Practice Guidelines on Anemia and CKD.
A key aspect of the update, which includes a new meta-analysis of all published trials, is its emphasis on clinical judgment and the needs of the individual patient receiving Erythropoiesis Stimulating Agent (ESA) therapy. In the new statements, the work group recommends what factors should be considered in selecting a Hb target and states that the selected Hb target should generally be in the range 11.0 to 12.0 g/dL. They point out that because of natural fluctuations, actual Hb results will vary widely from Hb targets.
Based on their analysis, the work group upgraded one of its opinion-based statements to an evidence-based guideline recommending that, in dialysis and non-dialysis CKD patients receiving Erythropoiesis Stimulating Agent (ESA) therapy, the Hb target should not be above 13.0 g/dL.
The work group -- made up of 16 volunteer experts in nephrology, hematology, epidemiology, nutrition, pharmacology, nursing, internal medicine and pediatrics -- previously worked for two years analyzing peer-reviewed data on diagnosis and treatment of anemia at all stages of CKD. Their initial Guideline was published last May.
Anemia in end-stage renal disease (ESRD) is associated with increased mortality and hospitalization, decreased mental acuity, cardiac enlargement, heart failure, reduced health-related quality of life and impaired rehabilitation.
The work group carefully reviewed data available since the publication of the last anemia update to develop this new set of clinical practice recommendations and guidelines,” says Dr. Michael Rocco, Vice-chair of KDOQI.
The recommendation to keep Hb targets below 13.0 g/dL is based on a review of all-cause mortality and adverse cardiovascular events in clinical trials where patients were assigned to Hb targets exceeding 13.0 g/dL. Evidence showing a trend toward greater number and severity of cardiovascular events in dialysis and non-dialysis patients assigned to Hb targets above13.0 g/dL was rated to be of moderately high quality for showing harm, and of high quality for showing lack of benefit.
To provide the best balance between the benefits of anemia treatment and the risks associated with Hb targets above 13.0 g/dL, the work group recommended that the selected Hb target should generally be in the range of 11.0 and 12.0 g/dL” says Dr. David Van Wyck, Co-Chair of the Work Group. He pointed out that benefits of ESA therapy include both transfusion avoidance and quality of life gains. The work group agreed, however, that further research is needed and should be encouraged.
The US Food and Drug Administration (FDA) has placed an upper limit for target Hb at 12.0 g/dL. Recently, the agency issued a black boxed warning for ESAs in light of new data that suggested non-dialysis CKD patients who were taking ESAs at doses designed to raise Hb to above 13 g/dL had a higher risk of death, blood clots, strokes, and heart attacks.
About the National Kidney Foundation and KDOQITM
The National Kidney Foundation is dedicated to preventing kidney and urinary tract diseases, improving the health and well being of individuals and families affected by these diseases, influencing public policy in support of the kidney community and increasing the availability of all organs for transplantation. KDOQITM is dedicated to improving the quality of care for patients at every stage of the disease – from the onset of chronic kidney disease through kidney failure. The KDOQITM guideline on anemia management was reviewed by over 1,000 individuals, organizations, companies, government agencies and members of the lay public. For more information visit www.kidney.org