Esa dose adjustment in dialysis patients implications for esa prescribing information
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ESA Dose Adjustment in Dialysis Patients: Implications for ESA Prescribing Information. Robert Provenzano, MD DaVita. Cohort-1 (Hb 12-13g/dl) Hemodialysis Patients Hb 12-13 g/dL end of month, December 2006 Level of dose decrease in January 2007 10-25%, 26-50%, 51-99%, or 100%

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Esa dose adjustment in dialysis patients implications for esa prescribing information l.jpg

ESA Dose Adjustment in Dialysis Patients: Implications for ESA Prescribing Information

Robert Provenzano, MD

DaVita


Slide2 l.jpg

Cohort-1 (Hb 12-13g/dl) ESA Prescribing Information

Hemodialysis Patients

Hb 12-13 g/dL end of month, December 2006

Level of dose decrease in January 2007

10-25%, 26-50%, 51-99%, or 100%

Follow month-to-month Hb changes through June 2007

Cohort-2 (Hb >13g/dl)

Hemodialysis Patients

Hb > 13 g/dL end of month, December 2006

Level of dose decrease in January 2007

10-25%, 26-50%, 51-99%, or 100%

Follow Hb changes through June 2007

Relationship between degree of dose reduction and Hb outcomes in patients with initial Hb 12-13 g/dL or Hb > 13 g/dL


Slide3 l.jpg
Holding Epoetin alfa when Hb is 12-13 g/dL increases relative risk of both low Hb early and high Hb later

Source: DaVita internal data



Larger epoetin dose reductions are associated with higher epoetin dose requirements l.jpg
Larger epoetin dose reductions are associated with higher epoetin dose requirements

Source: Data from Thamer M et al. JAMA 297 (15):1667-1674, 2007, Table 2.


Better anemia management is also associated with higher epoetin dose requirements l.jpg
Better anemia management is also associated with higher epoetin dose requirements

Source: Data from Thamer M et al. JAMA 297 (15):1667-1674, 2007, Table 2.



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Administer Patients, 1985-2002 EPOGEN® at the lowest dose needed to achieve

a hemoglobin > 11g/dL. Decrease the EPOGEN® dose if

the hemoglobin exceeds 12g/dL or the hemoglobin rate

of rise exceeds 1g/dL per two weeks or 2g/dL per 4 weeks.


Conclusions l.jpg
Conclusions Patients, 1985-2002

  • Create Policies & warning specific to the CKD/ESRD population

  • Do not encourage withholding epoetin alfa as standard practice or making large dose decreases for Hb values above target:

    • Dangerous

      • Increases risk of early, serious anemia

    • Counterproductive

      • Increases risk of later, above-target Hb

    • May increase epoetin utilization

  • Current CMS regulations and Clinical Performance Measures

    • Are safe, sufficient, and well-supported by evidence

  • Do not underestimate or undervalue QOL…


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