Anemia in the News

FDA Calls for Reevaluation, Refined Methods for ESA Use in Kidney Disease

January 11, 2010

The authors, speaking on behalf of the FDA’s Center for Drug Evaluation and Research, highlighted the need to refine ESA guidelines through a variety of randomized clinical trials, notably to establish an optimal hemoglobin target, dosing algorithm and monitoring approach.

The research called for would explore dosing targets well below 12 g/dL, more frequent monitoring, and more cautious dosing algorithms to lower dosage amounts and reduce overshoots and oscillations in patient’s hemoglobin levels. The authors also advocated for evaluating the effectiveness of these various approaches.

Published results from the TREAT trial,2 despite some limitations, have renewed fervent debate over the safety and effectiveness of ESAs to treat anemia in kidney disease patients not on dialysis and contribute to growing concerns from previously suspended clinical trials like CHOIR and the Normal Hematocrit Study.3,4

Published online January 6th, the article Erythropoiesis-Stimulating Agents — Time for a Reevaluation can be viewed for free on the New England Journal of Medicine website.

References

  1. Unger EF, Thompson AM, Blank MJ, Temple R. Erythropoiesis-Stimulating Agents -- Time for a Reevaluation. N Engl J Med. 2010 Jan 21;362(3):189-92. Link.
  2. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R; the TREAT Investigators. A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. N Engl J Med. 2009 Nov 19;361(21):2019-32.
  3. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med. 1998 Aug 27;339(9):584-90. Link.
  4. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. Link.

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