Trick or Treat? On Friday night, only hours before Halloween, the much-anticipated TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) will be presented by Marc Pfeffer as a late-breaking clinical trial as part of Renal Week in San Diego. CardioBrief will have full coverage of the trial at 8:40 PM.
However, CardioBrief readers may be interested to learn that some of the major results were released by Amgen in their third-quarter conference call on October 21. Here is the relevant paragraph from the company’s press release:
“Aranesp: The Company discussed the large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type-2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp(®) Therapy, or TREAT). Treatment of anemia with Aranesp to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment. The two primary endpoints were a composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) and a composite of time to all-cause mortality or chronic renal replacement therapy. Among the components of the TREAT outcomes measures, stroke, which has been noted in the Aranesp label since 2001, was more likely to occur in the patients who received Aranesp (101 patients [5.0 percent] vs. 53 patients [2.6 percent]; hazard ratio, 1.92; 95 percent CI, 1.38 to 2.68; P<0.001). Further, among patients with a history of cancer at baseline, there were 60 deaths from any cause in the 188 patients assigned to Aranesp and 37 deaths in the 160 patients assigned to placebo (P=0.13 by the log-rank test). In this subgroup, 14 of the 188 patients assigned to Aranesp died from cancer, as compared with 1 of the 160 patients assigned to placebo (P=0.002 by the log-rank test). Aranesp treatment was associated with a statistically significant reduction in blood transfusions. Additional data will be published soon and presented at the American Society of Nephrology Renal Week on October 30th and the American Heart Association scientific sessions in November.”
Click here for a PDF of the full Amgen third quarter earnings press release.