Aranesp flunks heart-failure trial, raising new questions about use
|Aranesp--courtesy of Amgen|
Is Aranesp becoming an Amgen ($AMGN) jinx? Less than a month after the company made headlines with a $762 million marketing settlement with the U.S. government, focused largely on Aranesp, Amgen says the anemia drug fell short in a trial in heart failure patients.
The trial followed 2,278 heart failure patients who also had anemia. One arm received placebo; the other, Aranesp. The goal was to show that treating that anemia with Aranesp would also improve patients' cardiovascular outcomes. But the drug didn't delay death (from any cause) or hospitalization for heart failure.
The one bright spot in the study was that it didn't uncover any new safety issues with Aranesp. At this point, however, the anemia drug has been associated with a variety of serious side effects in patients with chronic kidney disease (CKD), including heart problems and an increased risk of death, particularly at higher doses.
Dr. Sanjay Kaul, the Cedars-Sinai cardiologist, tells CardioBrief that the new study should give regulators and payers pause. "The null results ... together with the negative results of Aranesp for CKD reignite the debate around the continued use (and abuse) of Aranesp," Kaul told CardioBrief (via Forbes). "An agent that has not been shown to have any positive impact on patient-related outcomes continues to be a blockbuster with over $1 billion in annual sales in the U.S."