Peginesatide May Increase Risk Of CV Events In CKD Patients Not Undergoing Hemodialysis.

MedPage Today  (1/24, Gever) reports, "The anemia drug peginesatide (Omontys) in chronic kidney disease patients not undergoing hemodialysis may carry an increased risk of cardiovascular events, results of two paired trials suggested." Investigators reported that "pooled data from two studies enrolling such patients - dubbed PEARL-1 and PEARL-2 - yielded a hazard ratio of 1.32 for a composite safety endpoint that included all-cause mortality, stroke, myocardial infarction, congestive heart failure, unstable angina, and cardiac arrhythmia (95% CI 0.97 to 1.81) with peginesatide relative to darbepoetin alfa (Aranesp)." Meanwhile, "no such increase in cardiovascular risk was seen in two other trials labeled EMERALD 1 and 2 that used the identical composite safety endpoint but enrolled patients who were on dialysis." The findings were published in the New England Journal of Medicine.