Use of erythropoiesis-simulating agents (ESAs) to treat anemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) declined markedly since the October 2009 publication of the landmark TREAT study, a trend that continued following the June 2011 issuance of FDA safety warnings about ESA use, according to a new study. Meanwhile, the use of intravenous (IV) iron supplementation in this patient population increased.
Results from TREAT [Trial to Reduce Cardiovascular Events with Aranesp Therapy] showed that treatment with darbepoetin did not decrease the risk of death or cardiovascular events, but did result in a 2-fold increased risk of stroke in NDD-CKD patients. In June 2011, the FDA changed ESA labeling to recommend that ESAs should no longer be prescribed to obtain a target hemoglobin level range (10 to 12 g/dL), but should only be used for patients with hemoglobin levels below 10 g/dL, were symptomatic, and to avoid blood transfusions.
The new study looked at Medicare and commercially-insured patients with NDD-CKD. Among Medicare patients, the odds of ESA prescribing were a significant 31% and 59% lower in the post-TREAT and post-FDA warning periods, respectively, compared with the pre-TREAT period, Haesuk Park, PhD, of the University of Florida College of Pharmacy in Gainesville, and colleagues reported in BMC Nephrology. The odds of IV iron prescribing did not change significantly in the post-TREAT period, but were a significant 11% higher in the post-FDA warning period compared with the pre-TREAT period. The odds of being prescribed a blood transfusion were a significant 14% and 31% higher during the post-TREAT and post-FDA warning periods, respectively, compared with the pre-TREAT period.
In the commercially-insured group, the odds of ESA prescribing were a significant 45% and 74% lower in the post-TREAT and post-FDA warning periods, respectively. The odds of IV iron prescribing did not increase significantly in the post-TREAT period, but increased by a significant 6% in the post-FDA warning period. Use of blood transfusions did not change significantly.
“These results suggest that in Medicare patients, the use of iron and blood transfusions substituted the use of ESAs to treat anemia associated with CKD,” the authors wrote. “Interestingly, in our study, although changes in the use of ESAs were substantial, the use of iron and blood transfusions did not increase significantly in commercially-insured patients.”
The reasons for this finding could reflect differences in clinical practice for elderly patients with CKD who have cardiovascular morbidities and differences in insurance coverage for IV vs oral medications, in addition to a lower prevalence of anemia treatment among younger commercially-insured patients compared with older Medicare patients, according to the investigators.
Using the Medicare Supplemental and Truven MarketScan Commercial databases, the investigators identified 157,293 Medicare and 361,385 commercially-insured unique patients from January 2006 to September 2015 who had non-dialysis-dependent CKD.
They defined the pre-TREAT period as the 45 months from January 2006 to September 2009 (a month before TREAT results were published). The post-TREAT period spanned from the 20 months after publication of TREAT results until May 11, a month before the FDA warnings were released. The post-FDA period encompassed the 51 months from the FDA warnings to the end of the study (from June 2011 through September 2015).
Park H, Liu X, Henry L, et al. Trends in anemia care in non-dialysis-dependent chronic kidney disease (CKD) patients in the United States (2006-2015). BMC Nephrol. 2018; published online ahead of print.