The Clinical Journal of the American Society of Nephrology published our paper:
The Estimated Effect of Epoetin Dose on Survival among Elderly Hemodialysis Patients in the United States"
Zhang Y, Thamer M, Cotter D, Kaufman J, Hernan MA Clin J Am Soc Nephrol. 2009 Mar;4(3):638-644
Bethesda, Maryland - March 16, 2009 Almost nineteen years after epoetin was first approved by the FDA for the treatment of anemia associated with chronic renal failure, the relationship between dose and mortality remains unknown. Based on the 1989 FDA approval, epoetin is intended to treat blood transfusion dependent dialysis patients (representing ~10-30% of the 1988 ESRD patient pool ). Today epoetin treatment is provided to virtually all dialysis patients, costing Medicare in excess of $20 billion and ESRD patients over $4 billion through 2008.
This relationship has received much scrutiny of late by FDA and others given results from several terminated trials suggesting that patients randomized to higher hematocrit target arms and receiving at least twice the dose of epoetin as those in the lower arm, are at higher risk of mortality and adverse cardiovascular outcomes. Our analysis uses a cumulative epoetin dose as the exposure and mortality as an endpoint - we found no relationship between high dose and improved survival in the first year after dialysis therapy is initiated.
However, a corollary finding is the lack of an increased mortality risk for patients with higher doses which has important policy implications. Further research is needed to identify cardiovascular risks associated with dialysis patients who are epoetin hyporesponsive and/or treated for cancer.
In this study, dialysis patients with cancer were excluded from the analysis given the restrictions on epoetin use and safety concerns arising from cancer randomized epoetin trials. Responsiveness to epoetin therapy has been implicated in predicting mortality and deserves further study as discussed in our paper. Finally, this analysis used cumulative epoetin dose as the exposure of interest; studies looking at short-term exposure might have different results.
This real-world analysis of treatment effects using administrative data, a technique that mimics a randomized control trial. Such studies are of growing interest to policymakers as they address numerous health care controversies.
Research was supported in part by NIH grants R01-DK066011-01A2 and R01- HL080644-01. For more information on our other EPO-related research activities, visit www.mtppi.org or contact:
Dennis J. Cotter
President
Medical Technology and Practice Patterns Institute, Inc.
4733 Bethesda Ave., Suite 510
Bethesda, MD 20814
(301) 652-4005
fax: (301) 652-8335
dcott@mtppi.org