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In This Issue:
Hicham Skali, MD, and Marc A. Pfeffer, MD, both of BWH's Cardiovascular Division, look over information about the TREAT study, which found the drug Aranesp doubled the risk of stroke
in patients with diabetes and kidney disease without substantially improving their quality of life.
BWH researchers and international collaborators discovered that patients with diabetes and chronic kidney disease who took a popular drug to treat anemia were just as likely as those who took a placebo to develop cardiovascular problems or even death. Previously thought to help boost hemoglobin levels and reduce cardiovascular events, the drug darbepoetin alfa (Aranesp) actually also increased patients’ risk of stroke.
“Chronic kidney disease can be associated with anemia, and both of these factors greatly increase the risk of a patient with diabetes having premature adverse cardiovascular events and progressing to dialysis,” said Marc Pfeffer, MD, PhD, lead investigator and senior physician in Cardiovascular Medicine. “We tested whether the treatment of anemia with Aranesp would reduce the dreaded complications of diabetes: heart failure, myocardial infarction, stroke, end-stage renal and death.”
Prior to TREAT, or the Trial to Reduce Cardiovascular Events with Aranesp Therapy, the assumption of the drug’s benefits was so strong that many studies did not use placebo, according to Pfeffer. “Previous studies used two groups at different levels of treatment,” he said. “We stepped back and asked the most fundamental question: will this treatment improve outcomes?”
TREAT launched in 2004 as a randomized, placebo-controlled study of more than 4,000 patients with type 2 diabetes, chronic kidney disease and anemia. It is the largest trial to date to examine the use of erythropoiesis stimulating agents, a class of drugs approved to raise hemoglobin levels, and the only study to compare morbidity and mortality outcomes against placebo.
“The predominant findings are that the risks of Aranesp were higher than we thought and the benefits lower, which will impact how physicians and patients decide to use this mode of therapy,” said Pfeffer.
Pfeffer added that Aranesp did have some benefits for the patients studied, but that those benefits were outweighed by the increased risk of stroke in most patients.
“The major recommendation is for physicians and patients to use this vital information to make more accurate, informed decisions about their care together,” said Pfeffer.
The research was supported by and conducted in collaboration with Amgen, which makes Aranesp.
The findings, which were published online in the New England Journal of Medicine, were presented at the Annual Scientific Meeting of the American Society of Nephrology in San Diego Oct. 30.