Balancing Benefit and Risk in Treating Anemia in Chronic Kidney Disease:

New York, NY (September 10, 2007) - The care of America’s kidney patients, especially those on dialysis who receive expensive, yet important therapy to treat their anemia, has recently been the focus of a great deal of attention in both the popular and scientific press. Anemia in kidney failure or end stage kidney disease is associated with increased mortality and hospitalization, heart failure, reduced health-related quality of life and impaired rehabilitation.

The treatment of anemia experienced by chronic kidney disease patients, both on and off dialysis, requires advanced scientific perspective as well as a commitment to patient wellbeing and responsible investment of scarce resources.

On behalf of the 50,000 patients and health professionals who comprise our membership, we at the National Kidney Foundation wish to commend the Food and Drug Administration for its concern about the safe and effective use of treatments for anemia affecting Americans with CKD. Especially since 1989 when the FDA first approved the use of erythropoesis-stimulating agents, or ESAs, this drug therapy has proven to be invaluable for treating the underlying anemia experienced by hundreds of thousands of people with kidney failure.

Last week, after an extensive review of results from six new randomized controlled trials comparing risks and benefits of a range of target hemoglobins in CKD patients, a National Kidney Foundation work group issued an official update of its 2006 Clinical Practice Guidelines on Anemia and CKD. The work group that produced the update was comprised of 14 recognized experts organized as part of the Kidney Disease Outcomes Quality Initiative (KDOQI). The update, which includes a new meta-analysis of all published trials, emphasizes clinical judgment and the needs of the individual patient receiving ESA therapy. To provide the best balance between the benefits of anemia treatment and the risks associated with hemoglobin targets above 13.0 g/dL, the work group recommended that the selected hemoglobin target should generally be in the range of 11.0 and 12.0 g/dL

Improvement in every patient’s quality of life, in addition to quantity of life or survival, is a key consideration of the work group’s guidelines. So, too, are patient empowerment and the maintenance of strong patient-doctor partnerships that will be able to weigh risk-benefit factors and make decisions on a personalized, case-by-case basis.

Celeste Castillo Lee would agree. In the mid-1980s, when she was a college student with kidney failure, Ms. Castillo Lee recalls “on those days when I would be transfused, I would go out partying with my friends, but most of the time, all I can remember was being cold, tired and out of breath.”

Having been on and off dialysis since 1983, she believes that the “only real advancement” in the process and technology for dialysis over the last 20 years has been the effectiveness of the medication she takes to treat her anemia. Now at 42, Ms. Castillo Lee leads a full, active life as a Duke University administrator despite undergoing dialysis three times a week. She says her hemoglobin level of approximately 11.5 g/dL has been “a crucial factor for my quality of life and my ability to sustain full-time employment.” Ms. Castillo Lee acknowledges that dialysis still keeps her on the “sidelines” some of the time but her anemia-medication therapy “allows me to play in the game.”

Indeed, in a National Kidney Foundation patient survey last month, 71% of dialysis patients strongly agreed that their anemia medications “make a noticeable difference in how they feel.” And one patient added, “It has made a HUGE difference in my life…I have been able to work full time for the past 14 years.”

The National Kidney Foundation (NKF) agrees that hemoglobin targets should be designed to virtually eliminate blood transfusions in the CKD patient population. We are committed to helping physicians and their kidney patients design a strategy that will optimize each patient’s anemia management. That strategy must be based on the scientific evidence and take into account variations in risk and benefit based in the individual patient’s need and choice.

The recommendation to keep hemoglobin 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 hemoglobin targets exceeding 13.0 g/dL. The US Food and Drug Administration (FDA) has placed an upper limit for target hemoglobin at 12.0 g/dL. Significantly, in the same patient survey noted above, 86% of the respondents agreed “how medications are taken should be a decision that is made by me and my doctor.”

The NKF stands ready to assist the Federal Drug Administration in achieving the goals of improved health care based on available scientific evidence and knowledge while maximizing patient wellbeing.