Influence of safety warnings on ESA prescribing among dialysis patients using an interrupted time series

BACKGROUND: In March, 2007, a black box warning was issued by the Food and Drug Administration (FDA) to use the lowest possible erythropoiesis-stimulating agents (ESA) doses for treatment of anemia associated with renal disease. The goal is to determine if a change in ESA use was observed following the warning among US dialysis patients. METHODS: ESA therapy was examined from September 2004 through August 2009 (thirty months before and after the FDA black box warning) among adult Medicare hemodialysis patients. An interrupted time series model assessed the impact of the warnings. RESULTS: The FDA black box warning did not appear to influence ESA prescribing among the overall dialysis population. However, significant declines in ESA therapy after the FDA warnings were observed for selected populations. Patients with a hematocrit ≥36% had a declining month-to-month trend before (−164 units/week, p = <0.0001) and after the warnings (−80 units/week, p = .001), and a large drop in ESA level immediately after the black box (−4,744 units/week, p = <.0001). Not-for-profit facilities had a declining month-to-month trend before the warnings (−90 units/week, p = .009) and a large drop in ESA dose immediately afterwards (−2,487 units/week, p = 0.015). In contrast, for-profit facilities did not have a significant change in ESA prescribing. CONCLUSIONS: ESA therapy had been both profitable for providers and controversial regarding benefits for nearly two decades. The extent to which a FDA black box warning highlighting important safety concerns influenced use of ESA therapy among nephrologists and dialysis providers was unknown. Our study found no evidence of changes in ESA prescribing for the overall dialysis population resulting from a FDA black box warning

Who Is at Risk for New Hepatitis B Infections Among People With HIV?

Hepatitis B virus (HBV) increases morbidity and mortality among people with HIV (PWH). We retrospectively analyzed HBV incidence among 5785 PWH. Fourteen had newly positive hepatitis B s antigen (mean 5.2 person-years of follow-up, 46.4/100 000 infections/year). These data show gaps in HBV vaccination and in the preventative efficacy of HBV-specific antiretroviral therapy

Secular trends in recombinant erythropoietin therapy among the U.S. hemodialysis population: 1990–1996

Secular trends in recombinant erythropoietin therapy among the U.S. hemodialysis population: 1990–1996.BackgroundChronic anemia is a major cause of morbidity among the end-stage renal disease (ESRD) population. Recombinant erythropoietin (rHuEPO) has been recognized as a major advance in the treatment of anemia among the ESRD population. This study examines the secular trends in the use of and response to rHuEPO therapy among severely, moderately and mildly anemic hemodialysis patients.MethodsWe designed a cohort analytic study using seven years of claims data. The study population comprised all facility-based adult hemodialysis patients receiving rHuEPO therapy, who were initially reimbursed by Medicare in each of the first quarter of the calendar years 1990 through 1996 (N = 64,957).ResultsBetween 1990 and 1996, the mean rHuEPO dose increased by 139% for the patient cohorts with a first observed hematocrit <0.25, 122% for the 0.25 to 0.29 cohorts, and 107% for the ≥0.30 cohorts, and produced a 0.02 to 0.03 increase in achieved hematocrit (A-Hct) over this time. Dosing of rHuEPO did not appear to be influenced by patient or provider characteristics, although African-Americans, the elderly, non-diabetics and persons receiving dialysis in a non-profit facility had a larger percent change in hematocrit compared to their counterparts (P < 0.001).ConclusionsThe results of the clinical use of rHuEPO seven years after FDA approval found in the general ESRD hemodialysis population have not equaled the results obtained in the initial clinical trials. Overall, our findings suggest that substantial increases in rHuEPO dose provided to anemic patients have resulted in only modest increases in hematocrit in the seven years since rHuEPO's introduction. Resistance to rHuEPO, prior rHuEPO treatment, inadequate use of supplemental iron, and policy and financial incentives may explain this finding