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Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today
Date:10/18/2010

Aranesp to a target hemoglobin of 13 g/dL or placebo. Due to the increased risk of negative outcomes associated with low hemoglobin levels, patients in the control arm whose hemoglobin fell below 9 g/dL were given Aranesp as a rescue medication until their hemoglobin level reached 9 g/dL. Investigators were blinded to this intervention.

The key findings from TREAT include:

  • The study failed to meet either of its primary endpoints of:
  • improving mortality and CV morbidity or
  • extending time to death or ESRD

  • TREAT showed:
  • An almost 2-fold increased risk of stroke (HR = 1.92 [95 percent CI: 1.38-2.68], annualized incidence rate 2.1 percent vs. 1.1 percent) in the Aranesp arm
  • Among patients with history of malignancy, a higher number of deaths due to any cause and of death adjudicated as due to malignancy in the Aranesp arm
  • Aranesp therapy significantly reduced the need for transfusions
  • A statistically-significant but clinically modest improvement in patient-reported outcomes for patients in the Aranesp arm

  • Chronic Kidney Disease: Impact and PrevalenceCKD affects more than 26 million Americans and millions more worldwide. The disease is characterized by progressive kidney damage and impaired kidney function and is most often caused by type-2 diabetes or high blood pressure. When CKD progresses to kidney failure, chronic dialysis or a kidney transplant are required to sustain life. Anemia is a common complication of CKD that may begin in the early stages of the disease and becomes more common and severe as kidney function declines.

    About AranespAranesp was approved by the FDA in 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. The European Commission granted marketing authorization for the same indication in 2001 and subsequently updated it for CRF patients with symptomatic anemia in 2008.

    In 2002, the
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    SOURCE Amgen
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