Mean prescribed epoetin dose among hemodialysis patients receiving epoetin in the U.S. decreased by 15%, from 21,100 units/wk to 17,900 units/wk, from August 2010 to August 2011, with the greatest decline in dose seen between June and August 2011, according to the latest report from the Dialysis Outcomes and Practice Patterns Study’s Practice Monitor. Epoetin doses at the higher end of the dose range have decreased significantly.
The trends in hemodialysis care through August 2011 are included in the latest update to the DOPPS Practice Monitor (http://www.dopps.org/DPM), DOPPS is part of the Arbor Research Collaborative for Health.
Researchers update the monitor each quarter, based on a sampling of 140 U.S.-based dialysis clinics. The monitor was introduced last summer by DOPPS as a means of measuring the impact of the Prospective Payment System for dialysis care that took effect in January 2011. That payment system bundles Medicare reimbursement for dialysis care, including drugs, most lab tests, and the dialysis treatment.
In June 2011, the U.S. Food and Drug Administration approved revised prescribing information for erythropoiesis-stimulating agents (ESAs). Previously, the label recommended a hemoglobin target range of 10-12 g/dL. The June 2011 update removed the target range, advising instead to start ESA therapy for dialysis patients at hemoglobin less than 10 g/dL, and to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL.
Over the August 2010 to August 2011 time period, hemoglobin levels have decreased since the June 2011 ESA label update. While the mean hemoglobin level declined by 0.12 g/dL over 12 months from August 2010 to July 2011, it declined in August 2011 by another 0.10 g/dL to 11.26 g/dL. The percentage of patients with hemoglobin levels greater than 12 g/dL declined sharply (from 28% to 23%) in July/August 2011, while the percentage with hemoglobin levels less than 10 g/dL increased slightly from 8.5% to 10%. The percentage with hemoglobin levels less than 9 g/dL remained under 3%.
IV Iron Use
IV iron use has increased from August 2010 to August 2011, though has recently stabilized. In keeping with greater IV iron use, serum ferritin levels continue to rise. Serum ferritin concentration exceeded 500 ng/mL among 65% of patients, exceeded 800 ng/mL among 34% of patients, and exceeded 1,200 ng/mL in 11% of patients, in August 2011.
Concern about PTH levels
In the last DPM report, researchers noted a 29% increase in serum parathyroid hormone (PTH) levels through April 2011, and differences by race were noted. Since then, PTH levels have remained stable or declined slightly in both black and non-black patients. In August 2011, 22% of black patients and 12% of non-black patients had very high PTH values (defined here as PTH >600 pg/mL). The percentage of hemodialysis patients for whom PTH is measured has declined slightly since August 2010. There have been no clear changes in serum calcium or serum phosphorus levels.
Preliminary data indicate that the 30-day hospitalization rate has increased somewhat from August 2010 to August 2011. “The DPM does not report yet on trends in red blood cell transfusions, as dialysis units are often unaware of transfusions occurring in the inpatient setting,” the researchers said. “Additional efforts to comprehensively monitor trends in transfusions are warranted.” The patient community has voiced concerns that transfusions might increase if there was an increase in the number of patients with hemoglobin levels below 9 g/dL.