Adherence to Guidelines for ESRD Anemia Management

Hynes, Denise M.; Stroupe, Kevin T.; Kaufman, James S.; Reda, Domenic J.; Peterman, Amy H.; Browning, Margaret M.; Huo, Zhiping; Sorbara, Diego

doi:10.1053/j.ajkd.2005.11.012

Cited by 24 publications

(26 citation statements)

References 13 publications

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“…66 Observed compliance by providers with erythropoietin administration guidelines was higher at VA than in the private sector. 67 Antibiotic prescribing practices were generally similar between seven VA and seven non-VA emergency departments; however, in the three cities in which prescription rates were not comparable between VA and non-VA sites, VA sites had much higher rates of antibiotic prescriptions. 68 Availability of Services.…”

Section: Safetymentioning

confidence: 90%

Comparing VA and Non-VA Quality of Care: A Systematic Review

et al. 2016

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Section: Safetymentioning

confidence: 90%

Comparing VA and Non-VA Quality of Care: A Systematic Review

et al. 2016

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“…These concerns were cited as a basis for changes in NKF DOQI guidelines in 2006 and led to recommendations by Amgen and the Food and Drug Administration in 2005 and 2006 (17,19,21,45) that iv rather than sc epoetin be used to treat patients on hemodialysis, despite the fact that patients with rare cases of PRCA were observed primarily outside the United States and associated with Eprex, a form of epoetin not marketed in the United States (17)(18)(19). Although cases of PRCA have been documented in individuals treated with Epogen and Procrit (epoetin-a used in the United States), these cases have been extremely rare (incidence estimated at 0.2/100,000 patient-years) (18) and not exclusively associated with sc administration (18,19), consistent with our finding of only one possible patient with PRCA per 201,655 patient-years (associated with iv epoetin).…”

Section: Discussionmentioning

confidence: 99%

“…Concerns about patients with rare drug-associated PRCA have led to recommendations that patients on hemodialysis be treated with iv rather than sc epoetin (17,19,21). We, therefore, examined CMS records for occurrences of PRCA among 62,710 study participants within 5 years after their entry into the ESRD CPM Project.…”

Section: Association Of Epoetin Dose and Route Of Administration Withmentioning

confidence: 99%

“…This recommendation also reflected the principle of limiting drug use to the minimum required to achieve a therapeutic goal. Nonetheless, standard practice in the United States outside of the Veterans Affairs Health Care System (16) has been to treat patients on hemodialysis with iv epoetin (17). Convenience, patient comfort, and concerns about rare cases of pure red cell aplasia (PRCA) caused by drug-induced antierythropoietin antibodies have been rationales for favoring iv epoetin in hemodialysis management (17)(18)(19)(20)(21).…”

Section: Introductionmentioning

confidence: 99%

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Association of Erythropoietin Dose and Route of Administration with Clinical Outcomes for Patients on Hemodialysis in the United States

Wright¹,

Wright

Narva

et al. 2015

Clinical Journal of the American Society of Nephrology

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Background and objectives Recombinant human erythropoietin (epoetin) is used routinely to increase blood hemoglobin levels in patients with ESRD and anemia. Although lower doses of epoetin are required to achieve equivalent hemoglobin responses when administered subcutaneously rather than intravenously, standard practice has been to administer epoetin to patients on hemodialysis intravenously. Randomized trials of alternative epoetin treatment regimens in patients with kidney failure have shown that risks of cardiovascular complications and death are related to the dose levels of epoetin used. Therefore, given the dose-sparing advantages of subcutaneous epoetin administration, the possibility that treatment of patients on hemodialysis with subcutaneous epoetin might be associated with more favorable outcomes compared with intravenous treatment was investigated.Design, setting, participants, & measurements A retrospective cohort study of 62,710 adult patients on hemodialysis treated with either intravenous or subcutaneous epoetin-a and enrolled in the Centers for Medicare and Medicaid Services ESRD Clinical Performance Measures Project from 1997 to 2005 was carried out. Risks of death and/or hospitalization for cardiovascular complications (adverse composite event outcomes) during 2 years of follow-up were determined in relationship to epoetin dose and route of administration (intravenous versus subcutaneous) by multivariate Cox proportional hazard modeling adjusted for demographics and clinical parameters.Results Epoetin doses used to achieve equivalent hemoglobin responses in study patients were, on average, 25% higher when epoetin was administered intravenously rather than subcutaneously (as expected). Moreover, adverse composite event outcomes were found to be significantly more likely to occur during follow-up for patients on hemodialysis managed with intravenous rather than subcutaneous epoetin (adjusted hazard ratio for adverse events within 1 year [intravenous versus subcutaneous] was 1.11 [95% confidence interval, 1.04 to 1.18]).Conclusions This study finds that treatment of patients on hemodialysis with subcutaneous epoetin is associated with more favorable clinical outcomes than those associated with intravenous epoetin treatment.

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“…In the USA, reimbursement of injectable medications including ESAs is an important revenue source for privately owned dialysis units [52], and despite less favourable pharmacokinetics [47] and economics the IV route of administration is predominantly used in these facilities [53]. …”

Section: Continued Areas Of Uncertaintymentioning

confidence: 99%

Critiques of Clinical Guidelines in Nephrology: Anaemia

Courtney

Maxwell²

2008

Nephron Clin Pract

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Chronic kidney disease (CKD) is characterised by reduced erythropoietin production and anaemia. The introduction in the late 1980s of recombinant human erythropoietin transformed the quality of life and the blood transfusion requirements of patients with advanced CKD, and several erythropoietin analogues or derivatives with the collective name of erythropoiesis-stimulating agents (ESAs) are now available. However, despite the treatment of hundreds of thousands of patients with ESAs there have still been relatively few randomised controlled trials comparing outcomes at pre-specified haemoglobin (Hb) concentrations. Several unanswered questions remain regarding the optimal use of ESAs, including the ideal target Hb level for an individual and a CKD population. The conclusion from the available interventional studies is that there is no evidence for a beneficial effect of complete correction of Hb and there is weak evidence of harm with an increase in cardiovascular events and mortality. This has prompted some renal advisory bodies to modify their guidance on ESA prescribing. This critique reviews current clinical guidelines and recommendations, their scientific basis, and identifies areas of controversy including the role of newer agents, the long-term safety of ESAs, the influence of the pharmaceutical industry, and the associated healthcare costs.

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Adherence to Guidelines for ESRD Anemia Management

Cited by 24 publications

References 13 publications

Comparing VA and Non-VA Quality of Care: A Systematic Review

Comparing VA and Non-VA Quality of Care: A Systematic Review

Association of Erythropoietin Dose and Route of Administration with Clinical Outcomes for Patients on Hemodialysis in the United States

Critiques of Clinical Guidelines in Nephrology: Anaemia

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