Recommended erythropoietin-stimulating agent dosing changes for anemia care in adults undergoing hemodialysis led to lower erythropoietin-stimulating agent use and lower hemoglobin levels, according to a study published in the Clinical Journal of the American Society of Nephrology.
Haesuk Park, Ph.D., from the University of Florida in Gainesville, and colleagues examined anemia care and clinical outcomes before and after the U.S. Centers for Medicare & Medicaid Services bundled payment and the revised U.S. Food and Drug Administration-recommended erythropoietin-stimulating agent labeling for adults receiving hemodialysis.
Clinical outcomes, including major adverse cardiovascular events, cardiovascular mortality, and heart failure, were compared before (2006 to 2010) and after (2012 to 2016) policy implementation.
The researchers found that among the 481,564 patients, there was an immediate decrease in erythropoietin-stimulating agent use by 84.8 per 1,000 persons, with a significant decrease in the slope of the trend line. A rapid increase was seen in use of blood transfusion by 8.34 per 1,000 persons in April 2012, which then decreased gradually.
From January 2006 to December 2016, there was a decrease observed in the percentage of patients with hemoglobin >11 g/dL from 68 to 28 percent, whereas an increase from 5 to 9 percent was seen in those with hemoglobin <9 g/dL. Overall, risks were lower for major adverse cardiovascular events, stroke, all-cause mortality, cardiovascular mortality, and heart failure, while the risk for acute myocardial infarction increased after policy changes.
“Due to these significant changes in clinical outcomes, longitudinal follow-up is warranted to assess if the policy changes warrant further refinement,” Park said in a statement.
Several authors disclosed financial ties to the pharmaceutical and biopharmaceutical industries.