Erythropoietin-stimulating agents (ESAs) continue to be widely prescribed despite the absence of evidence demonstrating benefit. TREAT– the first and only large trial to test clinical outcomes with the drugs–showed that ESAs did not reduce clinical events, though it did raise concerns that the drugs might increase the risk of stroke. Critics say that the drugs…
Study Raises Questions About Transfusions In PCI Patients
February 25, 2014 by Leave a Comment
A very large observational study raises important questions about the role of transfusions in PCI patients in the US. In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study…
New Guideline Recommends Conservative Treatment for Heart Patients with Anemia
December 2, 2013 by Leave a Comment
The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions. “Overall,” wrote the authors, “despite the epidemiologic and…
Another Negative Trial With Darbepoetin Alfa
March 10, 2013 by 1 Comment
Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 2278 patients with systolic heart failure…
Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients
January 16, 2013 by Leave a Comment
The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said the trial had failed to meet its primary endpoint. The RED-HF…
Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp
December 18, 2012 by Leave a Comment
Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement…
Severe Blood Conservation Appears Safe In Cardiac Surgery For Jehovah’s Witnesses
July 2, 2012 by Leave a Comment
Severe blood conservation in conjunction with cardiac surgery is not associated with long-term adverse consequences, according to a new study published in Archives of Internal Medicine.  Investigators from the Cleveland Clinic and the NHLBI compared 322 patients who were Jehovan’s Witnesses with an equal number of matched controls. Due to their religious beliefs Witnesses…
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