Median hemoglobin levels fell 0.08 g/dL between August 2010 and July 2011, and by an additional 0.37 g/dL through October 2011, which reflects a sharper decline after the ESA label change, Bruce Robinson, MD, of Arbor Research in Ann Arbor, Mich., said..
Weekly ESA doses fell a median of 23 percent between August 2010 and December 2011, again with the sharpest decline after the label changes, Robinson said.
Levels of IV iron use steeply increased from 57 percent of patients getting iron in 2010 to 77 percent receiving it in December 2011. That corresponded with rises in serum ferritin— a median 25 percent increase over that time—although the potential long-term consequences of this finding aren't clear, Robinson said.
DOPPS also captured a jump in parathyroid hormone levels, which rose a median of 31 percent between August 2010 and April 2011, stabilizing through December 2011. There were no clear changes, however, in serum calcium or phosphate and no clear trends in the use of IV vitamin D, phosphorus binders, or cinacalcet, he reported.
As with the USRDS, Robinson and colleagues also saw a rise in transfusions, jumping from 2.21 percent of patients transfused in the hospital per month in September 2010 to 4.87 percent in September 2011, adding again that the database has capture issues with transfusion data because not all dialysis centers are aware of hospital-based transfusions.
And DOPPS data did show a rise in hospitalization rates, from 1.5 percent in August 2010 to just over 1.8 percent in November 2011, a trend that warrants closer monitoring, Robinson said.
The database also tracks international trends, and Robinson said hemoglobin levels in the U.S. appear to have fallen more in line with those of Europe and Japan since the policy changes.
He added that the Centers for Medicare and Medicaid Services recently convened a panel of technical experts to deal with these new challenges in anemia management, including the possibility of implementing pay-for-performance measures tied to limiting the number of transfusions—which may "point to a need for improved coordination of care and accountability across healthcare settings."
Vassalotti noted, however, that the big question remains: have the changes affected patient quality of life?
"It's hard to measure that," he said. "We don't have good data yet."
