Peginesatide is noninferior to epoetin for anemia in hemodialysis patients [EMERALD Trials]

1. Hemodialysis patients who received peginesatide had similar hemoglobin levels and similar rates of adverse events as patients who received traditional epoetin treatments.

Published today in NEJM, The EMERALD 1 and 2 trials evaluated the safety and efficacy of peginesatide for treatment of anemia in hemodialysis patients.

The study effectively demonstrated that peginesatide administered once a month was non-inferior to traditional erythropoiesis stimulating agents (ESAs) in maintaining hemoglobin at target levels.  This was found to be true for chronic kidney disease patients not on dialysis as well, albeit with a higher adverse event rate, in the PEARL trials published in the same issue. Adverse effects were similar in both groups in the EMERALD trials.

The study was appropriately powered to show safety and efficacy; however, a large proportion of patients prematurely discontinued the study, which may have skewed the results.  Additionally, the study’s exclusion criteria, which included hypertension or blood transfusions, weaken the study’s generalizability.

Click to read the study in NEJM

 

These [randomized controlled trials]: The EMERALD 1 and 2 trials, compared mean hemoglobin levels of hemodialysis patients who received either peginesatide or a traditional erythropoesis-stimulating agents (ESA) as treatment for anemia over an average of about 100 weeks.  The study found there was no significant difference in hemoglobin levels between patients receiving either treatment.  Additionally, the study found similar proportions of patients within each group that required blood transfusions, therapeutic phlebotomy, or experienced adverse events.  The study also found no significant difference in a prospectively determined composite safety end point, which included components such as death from any cause, stroke, myocardial infarction, heart failure, thromboemboloic events and other adverse events.  However, 8 patients in the peginesatide group developed neutralizing antibodies, while no ESA group patients developed epoetin-specific antibodies.

Further reading:

1. Peginesatide as a potential erythropoiesis stimulating agent

2. PEARL trial results: peginesatide for anemia in chronic kidney disease patients not on dialysis

In sum: The EMERALD 1 and 2 trials evaluated the safety and efficacy of peginesatide for treatment of anemia in hemodialysis patients.

The study effectively demonstrated that peginesatide administered once a month was non-inferior to traditional erythropoiesis stimulating agents (ESAs) in maintaining hemoglobin at target levels.  This was found to be true for chronic kidney disease patients not on dialysis as well, albeit with a higher adverse event rate, in the PEARL trials published in the same issue (2). Adverse effects were similar in both groups in the EMERALD trials.

The study was appropriately powered to show safety and efficacy; however, a large proportion of patients prematurely discontinued the study, which may have skewed the results.  Additionally, the study’s exclusion criteria, which included hypertension or blood transfusions, weaken the study’s generalizability.

Click to read the study in NEJM

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