A Randomized Comparison of Once Weekly Epoetin Alfa to Extended Schedule Epoetin or Darbepoetin in Chemotherapy‐Associated Anemia
This article is protected by copyright. All rights reserved. (Source: American Journal of Hematology)
Source: American Journal of Hematology - July 6, 2015 Category: Hematology Authors: David P. Steensma, Shaker R. Dakhil, Paul J. Novotny, Jeff A. Sloan, David B. Johnson, Daniel M. Anderson, Bassam I. Mattar, Dennis F. Moore, MD, Daniel Nikcevich, Charles L. Loprinzi Tags: Research Article Source Type: research
Anaphylactic Shock at the End of Hemodialysis.
We present a case of a hemodialysis patient who developed symptoms of an IgE-mediated allergic response to epoetin alfa that occurred after each administration. These reactions progressed to a single episode of anaphylaxis with generalized pruritus, urticaria, oropharyngeal edema, and hypotension that prompted its discontinuation. Intradermal skin testing confirmed an allergic response to this agent. The patient then underwent a desensitization procedure to epoetin alpha after which she was able to tolerate it without further problems.
PMID: 26147019 [PubMed - as supplied by publisher] (Source: Seminars in Dialysis)
Source: Seminars in Dialysis - July 4, 2015 Category: Urology & Nephrology Authors: Aziz N, Luna C, Mirza F, Tobin M Tags: Semin Dial Source Type: research
Mortality Risk of Darbepoetin Alfa Versus Epoetin Alfa in Patients With CKD: Systematic Review and Meta-analysis
Conclusions Few trials directly comparing DPO and EPO have been conducted and follow-up was limited. In aggregate, no effect of specific erythropoiesis-stimulating agent on mortality was identified, but the confidence limits were wide and remained compatible with considerable harm from DPO. Absent adequately powered randomized trials, observational postmarketing comparative effectiveness studies comparing these erythropoiesis-stimulating agents are required to better characterize the long-term safety profiles of these agents. (Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - June 22, 2015 Category: Urology & Nephrology Source Type: research
Rationale and study design of a randomized controlled trial to assess the effects of maintaining hemoglobin levels using darbepoetin alfa on prevention of development of end-stage kidney disease in non-diabetic CKD patients (PREDICT Trial)
Conclusion
PREDICT will determine the optimum target Hb for Japanese patients with non-diabetic CKD.
(ClinicalTrials.gov No. NCT01581073). (Source: Clinical and Experimental Nephrology)
Source: Clinical and Experimental Nephrology - June 17, 2015 Category: Urology & Nephrology Source Type: research
Longer-term Outcomes of Darbepoetin Alfa Versus Epoetin Alfa in Patients With ESRD Initiating Hemodialysis: A Quasi-experimental Cohort Study
Conclusions In incident hemodialysis patients, mortality and cardiovascular event rates did not differ between patients treated at facilities predominantly using DPO versus EPO. (Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - May 2, 2015 Category: Urology & Nephrology Source Type: research
Anaphylactic Shock at the End of Hemodialysis
We present a case of a hemodialysis patient who developed symptoms of an IgE‐mediated allergic response to epoetin alfa that occurred after each administration. These reactions progressed to a single episode of anaphylaxis with generalized pruritus, urticaria, oropharyngeal edema, and hypotension that prompted its discontinuation. Intradermal skin testing confirmed an allergic response to this agent. The patient then underwent a desensitization procedure to epoetin alpha after which she was able to tolerate it without further problems. (Source: Seminars In Dialysis)
Source: Seminars In Dialysis - May 1, 2015 Category: Hematology Authors: Nivin Aziz, Carla Luna, Farheen Mirza, Mary Tobin Tags: Dialysis Rounds Source Type: research
Comparative changes in treatment practices and clinical outcomes following implementation of a prospective payment system: the STEPPS study
Conclusions:
The economic pressure for dialysis providers to work within an expanded composite rate bundle whilst maintaining patient care may be a driver of practice indicator outcomes. Additional investigations are warranted to more precisely estimate clinical outcomes in patients attending facilities enrolling into the bundle 100% relative to the previous fee-for-service framework. (Source: BMC Nephrology)
Source: BMC Nephrology - May 1, 2015 Category: Urology & Nephrology Authors: Keri MondaParveen JosephPeter NeumannBrian BradburyRobert Rubin Source Type: research
Abstract S5-07: A randomized, open-label, multicenter, phase 3 study of epoetin alfa (EPO) plus standard supportive care versus standard supportive care in anemic patients with metastatic breast cancer (MBC) receiving standard chemotherapy
Background: Several investigational studies including MBC reported that erythropoiesis-stimulating agent (ESA) treatment beyond correction of anemia decreased survival and locoregional tumor control, and/or increased adverse effects, especially thrombotic vascular events (TVEs). These studies were reviewed at 3 FDA Oncologic Drugs Advisory Committee Meetings (2004, 2007, and 2008). Other studies and well-conducted meta-analyses did not suggest adverse effects on tumor outcomes when ESAs are used according to the prescribing information in subjects receiving chemotherapy, however, no study rigorously evaluated tumor outcome...
Source: Cancer Research - April 30, 2015 Category: Cancer & Oncology Authors: Leyland-Jones, B., Bondarenko, I., Nemsadze, G., Smirnov, V., Litvin, I., Kokhreidze, I., Abshilava, L., Janjalia, M., Li, R., Lakshmaiah, K., Samkharadze, B., Tarasova, O., Mohapatra, R. K., Sparyk, Y., Polenkov, S., Vladimirov, V., Xiu, L., Kimelblatt, Tags: General Session Abstracts Source Type: research
Abstract P4-11-06: TLE3 is not a predictive biomarker for taxane sensitivity in the NCIC CTG MA.21 clinical trial
Background: TLE3, a nuclear transcriptional repressor downstream of the WNT signaling pathway, has been identified as a candidate predictive biomarker of taxane benefit in early breast cancer. However, robust clinical evidence is required before implementing novel diagnostic biomarkers. We tested the hypothesis that TLE3 predicts for benefit from taxane containing polychemotherapy in the NCIC CTG MA.21 clinical trial.
Methods: MA.21 accrued 2104 patients [701 each to cyclophosphamide, epirubicin, and 5 fluorouracil (CEF) and epirubicin and cyclophosphamide with filgrastim and epoetin alfa followed by paclitaxel (EC/T), 702...
Source: Cancer Research - April 30, 2015 Category: Cancer & Oncology Authors: Bartlett, J. M., Nielsen, T. O., Gao, D., Gelmon, K. A., Quintayo, M. A., Starczynski, J., Han, L., Burnell, M. J., Levine, M. N., Shepherd, L. E., Chapman, J.-A. W. Tags: Poster Session Abstracts Source Type: research
National trends in prescription drug expenditures and projections for 2015.
CONCLUSION: Growth in U.S. prescription drug expenditures is expected to continue to increase in 2015. The projected increases in total drug expenditures are 7-9% across all settings, 12-14% in clinics, and 5-7% in hospitals. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2015.
PMID: 25873620 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)
Source: American Journal of Health-System Pharmacy : AJHP - April 17, 2015 Category: Drugs & Pharmacology Authors: Schumock GT, Li EC, Suda KJ, Wiest MD, Stubbings J, Matusiak LM, Hunkler RJ, Vermeulen LC Tags: Am J Health Syst Pharm Source Type: research
Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)
Conclusion
This large, prospective registry demonstrates that PRCA is rare with subcutaneous administration of either the new coated-stopper syringe presentation of Eprex®, or NeoRecormon® or Aranesp®. (Source: Nephrology Dialysis Transplantation)
Source: Nephrology Dialysis Transplantation - February 23, 2015 Category: Urology & Nephrology Authors: Macdougall, I. C., Casadevall, N., Locatelli, F., Combe, C., London, G. M., Di Paolo, S., Kribben, A., Fliser, D., Messner, H., McNeil, J., Stevens, P., Santoro, A., De Francisco, A. L. M., Percheson, P., Potamianou, A., Foucher, A., Fife, D., Merit, V., Tags: Chronic Kidney Disease Source Type: research
The Emerging Role of Biosimilar Epoetins in Nephrology in the United States
Publication date: Available online 10 January 2015 Source:American Journal of Kidney Diseases Author(s): Steven Fishbane , Hitesh H. Shah Biologic drugs, including epoetin, continue to play an important role in the management of medical conditions. However, biologics are costly and soon many of the patents on these drugs will expire, making way for non–brand name products (ie, biosimilars). It is only by introducing competition to the marketplace that costs will de-escalate. In Europe, a specific regulatory pathway for approving biosimilars has been in place since 2005. A similar review pathway in the United States...
Source: American Journal of Kidney Diseases - January 13, 2015 Category: Urology & Nephrology Source Type: research
Therapeutic efficacy of a biosimilar epoetin alfa in hemodialysis patients.
Abstract
Anemia is a frequent complication in patients with chronic kidney disease. However, human recombinant erythropoietin (rHu-EPO) has revolutionized the management of anemia in chronically dialyzed patients. Epomax ® is a new rHu-EPO alfa manufactured in Tunisia (Medis Laboratories). The aim of this study was to evaluate the efficacy and tolerance of Epomax ® in chronic hemodialysis (HD) patients in a phase-III, multicenter, clinical trial. Fiftythree HD patients (mean age 47.7 ± 13 years) who received a stable dose of rHu-EPO (Hemax ® , a rHu-EPO alfa manufactured by Biosidus Laboratories) subcu...
Source: Saudi Journal of Kidney Diseases and Transplantation - January 1, 2015 Category: Urology & Nephrology Authors: Harzallah A, Zouaghi K, Dridi A, Boubaker K, Beji S, Ayari M, El Younsi F, Moussa FB, Kheder A Tags: Saudi J Kidney Dis Transpl Source Type: research
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
CONCLUSIONS: In the CKD setting, there is currently insufficient evidence to suggest the superiority of any ESA formulation based on available safety and efficacy data. Directly comparative data for the effectiveness of different ESA formulations based on patient-centred outcomes (such as quality of life, fatigue, and functional status) are sparse and poorly reported and current research studies are unable to inform care. All proprietary ESAs (epoetin alfa, epoetin beta, darbepoetin alfa, and methoxy polyethylene glycol-epoetin beta) prevent blood transfusions but information for biosimilar ESAs is less conclusive. Compara...
Source: Cochrane Database of Systematic Reviews - December 8, 2014 Category: Journals (General) Authors: Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF Tags: Cochrane Database Syst Rev Source Type: research
Impact of a clinical pharmacy anemia management service on adherence to monitoring guidelines, clinical outcomes, and medication utilization.
CONCLUSIONS: A clinical pharmacist-managed anemia service resulted in improved adherence to national monitoring guidelines, equivalent quality and safety outcomes, and lower medication utilization compared with usual care.
PMID: 24967524 [PubMed - in process] (Source: Journal of Managed Care Pharmacy)
Source: Journal of Managed Care Pharmacy - November 14, 2014 Category: Drugs & Pharmacology Tags: J Manag Care Pharm Source Type: research
