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| |  Darbepoetin Alfa Risky for Type 2 Diabetics With Kidney Disease: Presented at AHA By Bruce Sylvester ORLANDO, Fla -- November 17, 2009 -- The risks outweigh potential benefits in using darbepoetin alfa to treat anaemia in type 2 diabetics with kidney disease, researchers reported here at the American Heart Association (AHA) Scientific Sessions 2009. “The effectiveness of treating these patients was less than we anticipated,” said Marc Pfeffer, MD, Brigham and Women’s Hospital/Harvard Medical School, Boston, Massachusetts, speaking here on November 16. “And the risk to these patients from the treatment was greater than we anticipated.” In the randomised, double-blind, placebo-controlled Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) initiated in 2004, Dr. Pfeffer and colleagues aimed to increase haemoglobin levels to 13 g/dL, expecting that such a level would reduce the likelihood of study subjects experiencing adverse coronary and renal endpoints. Eligible subjects were diagnosed with type 2 diabetes, chronic kidney disease (defined as an estimated glomerular filtration rate of 20 to 60 mL/min/1.73 m2), and anaemia (defined as haemoglobin levels <=11g/dL). Dr. Pfeffer reported that darbepoetin alfa therapy (n = 2,012) was more effective than placebo (n = 2,026) in improving haemoglobin levels over a 4-year period, but that improvements in control of anaemia did not translate into a lowering of the composite trial endpoint -- death, myocardial infarction, myocardial ischaemia, heart failure, or stroke. He added that 31.4% of the patients on darbepoetin alfa experienced the endpoint compared with 29.7% of the patients on placebo (P = .41). There were also no significant differences between the renal composite endpoint of death or end-stage renal disease, with 32.4% of patients on darbepoetin alfa experiencing that endpoint compared with 30.5% of placebo patients (P = .29). Dr. Pfeffer noted that a clinical trial testing darbepoetin alfa against placebo had not been performed before clinicians had begun using the drug off-label to correct anaemia in diabetics with kidney disease, since doctors were “sure” they were doing the right thing. “In the TREAT trial, we were trying to confirm that,” he said, “but we were unable to do it.” A major problem that appeared in TREAT was a significant increase in stroke. Of the 2,012 patients assigned to darbepoetin alfa, 101 (5%) had a stroke compared with 53 (2.6%) of the 2,026 placebo patients (P < .001). Venous thromboembolic events were reported in 41 (2.0%) patients in the darbepoetin alfa group compared with 23 (1.1%) patients in the placebo group (P = .02). Arterial thromboembolic events (some of which were adjudicated as cardiovascular events) were also reported more frequently in the darbepoetin alfa group. Dr. Pfeffer said 178 (8.9%) patients on darbepoetin alfa experienced arterial thrombotic events compared with 144 (7.1%) placebo patients (P = .04). Adjusted fatigue scores were not significantly different between the study cohorts. Spokesperson for the AHA, Raymond Gibbons, MD, Mayo Clinic, Rochester, Minnesota, concluded, “We made the assumption that more care is better care, and it didn’t turn out that way.” Funding for this study was provided by Amgen. [Presentation title: Trial to Reduce Cardiovascular Events With Aranesp Therapy. Abstract 09-LBCT-13782-AHA]
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