Preventing anemia is important to kidney disease patients' quality of life

Study indicates that FDA statements may need to be revised

13 nov 2008--Maintaining sufficient red blood cell levels is important to the physical and mental health of patients with chronic kidney disease (CKD), according to a study appearing in the January 2009 issue of the Clinical Journal of the American Society Nephrology (CJASN). The findings indicate that preventing anemia in kidney disease patients should be an integral part of their care.

Erythropoiesis-stimulating agents—medications that elevate red blood cell levels (hemoglobin)—have been a topic of controversy lately, and their use in patients with chronic kidney disease has come into question. Recent studies have shown an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when erythropoiesis-stimulating agents are given at higher than recommended doses. (Current recommendations indicate that treatment should not elevate hemoglobin levels over 12 gm/dl). Other studies have found a link between the recommended doses of these drugs and an increased risk of death in patients with cancer and an increased risk of blood clots in patients following orthopedic surgery. In addition, the US Food and Drug Administration stated that the benefits of erythropoiesis-stimulating agents have not been well documented, particularly as they relate to quality of life. These suggestions are disturbing to nephrologists, who believe that these drugs have significantly helped their CKD patients.

To help clarify the issue, Fredric Finkelstein, MD, of the Hospital of St. Raphael and Yale University in New Haven, CT, and his colleagues studied the relationship between hemoglobin levels and health-related quality of life (which includes both mental and physical components) in patients with CKD.

A total of 1,186 patients with stage three to stage five CKD participated in this study, and they were grouped into categories based on their hemoglobin levels (<11>

The study's findings suggest that maintaining hemoglobin levels is important to the health and well-being of patients with CKD. The authors recommend that additional studies should be done to document the changes in quality of life that occur when erythropoiesis-stimulating agents are used to elevate hemoglobin levels in patients with this disease.

More work also is needed to determine when treatment should be initiated and what the hemoglobin target level should be. "The impact of the answers to these questions for the health-related quality of life of chronic kidney disease patients may well be substantial," the authors wrote.

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The article, entitled "Health-Related Quality of Life and Hemoglobin Levels in Chronic Kidney Disease," is available online at http://cjasn.asnjournals.org and will appear in the January 2009 print issue of CJASN.