On January 16, 2013 Amgen announced recent clinical trial results that showed the failure of the anemia drug Aranesp (darbepoetin alfa) to meet primary endpoints for the treatment of symptomatic systolic heart failure and anemia. Aranesp was unsuccessful at reducing the time to death from any cause or first hospital admission for deteriorating heart failure. Researchers stated that no other safety findings were discovered through the study.
The trial included 2,278 patients with systolic heart failure and anemia who were assigned to receive either treatment with Aranesp or placebo. The most commonly reported adverse events during the study were cardiac failure, dyspnea (shortness of breath), diarrhea, congestive heart failure, and dizziness.
Aranesp (darbepoetin alfa) is indicated for treatment of anemia caused by chronic kidney disease (CKD). It is indicated for treatment of anemia caused by chemotherapy that will be used for at least two months after starting Aranesp treatment. Aranesp was FDA approved on September 17, 2001 and is manufactured by Amgen Inc.
FAERS data (from 11/01/1997 to 06/30/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 450 serious adverse events which listed Aranesp as the primary suspect in patients with cardiac failure and anemia. We identified 129 hospitalizations and 29 patient deaths where Aranesp was determined to be the primary suspect.
The most top three adverse events were therapeutic response decreased, hemoglobin decreased, and aplasia pure red cell (red blood cell loss).