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TREAT: Darbepoetin alfa does not reduce outcomes of death, cardiovascular events or end-stage renal disease
The researchers also reported elevated rates of stroke in patients receiving darbepoetin vs. placebo.
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American Heart Association Scientific Sessions 2009
The administration of darbepoetin alfa was not associated with a reduction in death, cardiovascular events or end-stage renal disease, according to results of the TREAT trial.
Researchers for TREAT enrolled 4,038 patients with type 2 diabetes, chronic kidney disease and concomitant anemia in the study and randomly assigned them to either receive darbepoetin alfa (n=2,012) or placebo (n=2,026). The primary study endpoint was a composite of death, myocardial infarction, unstable angina, heart failure or stroke, as well as a composite renal endpoint that included death or end-stage renal disease.
According to the study results, the composite of death, MI, myocardial ischemia, heart failure and stroke was similar in the darbepoetin alfa group vs. placebo (31.4% vs. 29.7%; HR=1.05; 95% CI, 0.94-1.17). Component endpoints were also similar between the darbepoetin alfa group and placebo, including for death (20.5% vs. 19.5%, P=.48), heart failure (10.2% vs. 11.3%, P=.24), MI (6.2% vs. 6.4%, P=.73) and myocardial ischemia (2.0% vs. 2.4%, P=.40). For the component endpoint of stroke, however, there was an increase in the darbepoetin group vs. placebo (5.0% vs. 2.6%, P<.001). There was no difference in the composite renal endpoint between the darbepoetin alfa and placebo groups (32.4% vs. 30.5%, P=.29), and there was no difference in end-stage renal disease (16.8% vs. 16.3%, P=.83). There was no statistical difference in the incidence of cancer between treatment groups (P=.53).
“In patients with type 2 diabetes and chronic kidney disease who are not on dialysis and who have anemia, the strategy to treat their anemia with darbepoetin did not reduce either of the composite endpoints,” Marc A. Pfeffer, MD, PhD, a professor of medicine at Brigham and Women’s Hospital in Boston, said in his presentation. “We did observe fewer patients needing red blood cell transfusions and did observe a rather moderate improvement in FACT-fatigue, but we also observed higher rates of stroke.” – by Eric Raible
For more information:
- Pfeffer M. LBCT 02 #114. Presented at: American Heart Association Scientific Sessions; Nov. 14-18, 2009; Orlando, Fla.
In order to move forward in this patient population, we might consider using a lower hemoglobin threshold for erythropoietin-stimulating agents, as has been done in cancer populations. We may also consider individualized hemoglobin targets based perhaps on age, race and sex. We could consider new goals of treatment, such as preventing hemoglobin declines to levels that are relevant for functional or chronic disease outcomes in these primarily older patients. There are also other primary outcomes to consider such as fatigue, which can be even more devastating than cardiovascular disease or stroke to our patients. We need to figure out ways to measure it carefully and assess it well. Should we give up on erythropoietin-stimulating agents in this population? That is for the community to decide, and I am not sure that would be a good idea.
– Mary Cushman, MD
Professor of Medicine and Pathology
University of
Vermont, Burlington