The anemia drug Aranesp, known generically as darbepoetin alfa, failed in clinical trials to treat heart failure and led to some participants experiencing serious adverse side effects, according to recent results of an Amgen drug trail.
The California based drug company revealed the results of its Phase 3 Aranesp RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial last week, which was a double-blind randomized study involving the effects of Aranesp in patients with heart failure and anemia. Aranesp is a common medication used to treat anemia in cancer patients.
While the study did not meet its primary endpoint and did not slow death or reduce hospitalization, many patients experienced multiple adverse effects including, cardiac failure, dyspnea, diarrhea, congestive heart failure and dizziness.
The placebo controlled trial, involving nearly 2,300 patients, hoped to slow the death rate or hospitalization for patients with anemia and worsening heart failure. Patients were categorized with New York Heart Association (NYHA) class II, III or IV heart failure and anemia in 2006 and had hemoglobin levels between 9 and 12 g/dL.
Amgen plans on reporting the full results of the study at an upcoming safety analysis meeting that will be shared with global regulatory agencies.
Illegal Promotions Led to Aranesp Settlement
News of the Aranesp trial failure follows a $762 million settlement reached in December to resolve an Amgen whistleblower lawsuit, which alleged the drug maker illegally promoted the medication.
The lawsuit claims Amgen encouraged doctors to use the drugs by overfilling vials by as much as 25 percent. It also alleges the drug company offered doctors discounts to use the drugs in large volume.
Other scandals surrounding the anemia drug involve Amgen offering false information regarding the safety of the drug. The company is reported to continue the use of lobbyists in congress to pressure lawmakers and the FDA to overlook claims of potential severe side effects, such as an increased risk of cancer and stroke.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of anemia associated with renal failure. It was also approved to treat anemia in patients with chronic kidney disease, who may or may not be on dialysis. Aranesp is also often used to treat patients with HIV and cancer to increase the production of red blood cells and to prepare patients undergoing major surgery, to reduce the number of transfusions necessary during surgery.
While the recent study found Aranesp not to improve the quality of life, fatigue or patient well-being during clinical testing, sales of the drug topped at $4.1 billion in 2006, and reached $3.1 billion in 2008 and $2.3 billion in 2011.