Erythropoiesis Stimulating Agents (ESAs) in the Treatment of Anemia by variablepitch342

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									Erythropoiesis Stimulating Agents (ESAs) in the Treatment of Anemia Associated with Chronic Renal Failure (CRF)
FDA Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee
Dwaine Rieves, MD Director (Acting) Division of Medical Imaging and Hematology Products

September 11, 2007

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Background ESAs: modified forms of erythropoietin Products:
– Epoetin alfa: Epogen/Procrit – Darbepoetin alfa: Aranesp

Indications: “treatment of anemia associated with CRF, including patients on dialysis and not on dialysis” Other indications
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Safety Concerns for CRF Patients
“Normal Hematocrit” Study
– On dialysis

CHOIR Study
– Not on dialysis

Both showed increased risk for targeting higher hemoglobin levels, compared to lower
Dose optimization
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Dose Optimization: Safety and Efficacy Considerations Efficacy: increase in hemoglobin level sufficient to avoid red blood cell transfusion

Patient-reported and Physicianassessed outcomes under re-evaluation:
– Instrument deficiencies

– Study design deficiencies
– Inconsistent or incomplete results
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Topic 1: Hemoglobin Goal When Using ESAs
Current: “lowest dose…that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for RBC transfusion” and “…not exceed 12 g/dL.” Discuss or develop a new proposal: – Efficacy, with – Safety considerations from NCT and CHOIR

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Topic 2: Identification and Management Of ESA “Hypo-responders” Current:
– “Lack or Loss of Response”
Identifies causes and need for treatment No ESA dose recommendations

Discuss or develop a new proposal:
– Existing information, with

– Dose and achieved hemoglobin data from NHCT and CHOIR
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Data Sources & Evidence for Drug Effects
R,C studies Observational studies

Randomization: helps establish drug effects Observational: detects associations Quality of evidence: “..was high if the evidence consisted of RCTs, low if it consisted of observational studies…”
http://www.kidney.org/professionals/KDOQI/guidelines_anemia/guide5.htm

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Agenda

Guest speakers
– Ajay Singh, MD

– Medical Technology and Practice Pattern Institute Representatives

Amgen/Ortho Biotech FDA Summary Afternoon:
– Public comments – Questions
Return to Rieves 8


								
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