What are ESAs or Erythropoeisis-Stimulating Agents?
Why are ESAs used in hemodialysis, dialysis and some CKD patients?
Erythropoiesis-stimulating agents or ESAs, are agents that increase the production of red blood cells by the bone marrow. In a beautiful example of the complicated interrelationships of our body's organs, the hormone erythropoeitin is produced by our kidneys and then alerts the bone marrow when more red blood cells are needed.
Because the kidneys are damaged with chronic kidney disease, many patients with CKD are anemic. Anemia means a low red blood cell count or low hematocrit (low hemoglobin level). Patients with anemia may experience undue fatigue. Anemia also puts a stress on the heart as the heart needs to pump harder to adequately oxygen the body.
In the last two decades, scientists and pharmaceutical companies have learned to replicate and produce the hormone Erythropoietin (Epo) in cell cultures. Epo is given in careful doses to dialysis and CKD patients to keep the hematocrit at an adequate level.
As with other hormones in the body, (such as insulin, thyroid hormone, steroid hormones and others),the correct amount of Epo for the individual person must be carefully titrated. Too much or too little Epo, an with any hormone, can have side effects. Too little Epo and the bone marrow does not make enough red blood cells to prevent a patient from requiring transfusions. Too much Epo, and the CKD or cancer patient may be at increased risk of blood clotting (thrombosis), stroke or hypertension.
Studies are being done by nephrologists (kidney specialists) and others to try to guage the correct hemoglobin level to aim for with Epo dosing, in order to balance the risks and benefits of Epo in patients with CKD and renal failure.
Other names for Erythropoiesis-stimulating agents:
Erythropoietin (Epo), Epoetin alfa (Procrit/Epogen) and Darbepoetin alfa (Aranesp).
ESAs | Erythropoeitin | Anemia and Chronic Kidney Disease and hemodialysis Patients
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Correction of Postkidney Transplant Anemia Reduces Progression of Allograft Nephropathy
Gabriel Choukroun, Nassim Kamar, Bertrand Dussol, Isabelle Etienne ,Elisabeth Cassuto-Viguier, Olivier Toupance, François Glowacki, Bruno Moulin, Yvon Lebranchu, Guy Touchard, Maïté Jaureguy, Nicolas Pallet, Yannick Le Meur, Lionel Rostaing, Frank Martinez, and for the CAPRIT study Investigators
JASN Dec 22, 2011 ASN.2011060546; published ahead of print December 22, 2011, doi:10.1681/ASN.2011060546
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Ikee R, Tsunoda M, Sasaki N, Sato N, Hashimoto N.
Nephrology (Carlton). 2011 Nov 24.
doi: 10.1111/j.1440-1797.2011.01545.x.
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Jula K Inrig, Suzanne K Bryskin, Uptal D Patel, Murat Arcasoy and Lynda A Szczech
BMC Nephrology 2011, 12:67 doi:10.1186/1471-2369-12-67
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ASN 2011 Abstract: [SA-PO2646]
Christopher S. Hollenbeak, PhD, Sumit Mohan, MD, Greg De lissovoy, PhD, Peter L. Quon, Matthew Gitlin, PharmD, Jill Javier, John J. Isitt, MS, William M. McClellan, MD. Penn State College of Medicine; Columbia University; Amgen Consultant; United BioSource Corp.; Amgen, Inc.; Emory University School of Medicine.
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Author Interview: Yong Kyun Kim MD
Relationship between erythropoietin resistance index and left ventricular mass and function and cardiovascular events in patients on chronic hemodialysis
Chung, S., Song, H. C., Shin, S. J., Ihm, S.-H., Park, C. S., Kim, H.-Y., Yang, C. W., Kim, Y.-S., Choi, E. J. and Kim, Y. K.
Hemodialysis International. (2011)
doi: 10.1111/j.1542-4758.2011.00644.
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Author Interview: Dr. Lucile Mercadal
Timing and Determinants of Erythropoietin Deficiency in Chronic Kidney Disease
Lucile Mercadal, Marie Metzger, Nicole Casadevall, Jean Philippe Haymann, Alexandre Karras, Jean-Jacques Boffa, Martin Flamant, François Vrtovsnik, Bénédicte Stengel, Marc Froissart, and on behalf of the NephroTest Study Group
CJASN November 17, 2011 CJN.04690511; published ahead of print November 17, 2011, doi:10.2215/CJN.04690511
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Authors' Interview: Jochen G. Raimann, MD (Senior Research Fellow) and
Nathan W. Levin, MD (Chairman of the Research Board).
Evaluation of the Predictive Value of Commonly Used Anemia Management Indicators in Incident Hemodialysis Patients
Abstract: [SA-PO2651]
Jochen G. Raimann, MD, Len A. Usvyat, Stephan Thijssen, MD,
Peter Kotanko, MD, Nathan W. Levin, MD.
Renal Research Institute; Beth Israel Medical Center. |
Author Interview: Mahesh Krishnan MD, MPH, MBA, FASN
Impact of Baseline Year on PPS Payments under the Quality Improvement Program
ASN 2011 Abstract: [SA-PO2639]
Andrew Barba, Randy Smith, Joe Weldon, LeAnne Zumwalt, Mahesh Krishnan, MD, FASN. DaVita Inc, Denver, CO. |
Author Interview: Dr. Miklos Zsolt Molnar, MD, PhD
Serum Erythropoietin Level and Mortality in Kidney Transplant Recipients.
Molnar MZ, Tabak AG, Alam A, Czira ME, Rudas A, Ujszaszi A, Beko G, Novak M, Kalantar-Zadeh K, Kovesdy CP, Mucsi I.
Clin J Am Soc Nephrol. 2011 Oct 6. [Epub ahead of print]
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Dose-finding Study of Peginesatide for Anemia Correction in Chronic Kidney Disease Patients.
Macdougall IC, Wiecek A, Tucker B, Yaqoob M, Mikhail A, Nowicki M, Macphee I, Mysliwiec M, Smolenski O, Sulowicz W, Mayo M, Francisco C, Polu KR,
Schatz PJ, Duliege AM
King's College Hospital, London, United Kingdom;
Clin J Am Soc Nephrol. 2011 Sep 22.
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Mortality risk in hemodialysis patients according to anemia control and erythropoietin dosing.
Hemodialysis International.
Santos, P. R., Melo, A. D. M., Lima, M. M. B. C., Negreiros, I. M. A. H., Miranda, J. S., Pontes, L. S., Rabelo, G. M., Viana, A. C. P., Alexandrino, M. T., Barros, F. A., Neto, B. R., Brito, A. A. and Da Silva Costa, A.doi: 10.1111/j.1542-4758.2011.00607.x 2011
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Hospira Announces Positive Results From Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients
First Phase III U.S. trial to begin later this year
LAKE FOREST, Ill., Sept. 6, 2011 /PRNewswire via COMTEX/ -- Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced positive results from a Phase I U.S. clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia. Hospira's trial met its key endpoint, showing equal pharmacokinetics, or blood level and distribution in the body, for Hospira's EPO and the reference product, Amgen's Epogen®. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.
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BusinessWire 7/27/2011
Affymax, Inc. (Nasdaq:AFFY) and Takeda Global Research & Development Center, Inc., U.S., today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.
If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.
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Battistella M, Richardson RM, Bargman JM, Chan CT.
Division of Nephrology, Department of Medicine, University Health Network, Toronto, ON, Canada.
Clin Nephrol. 2011 Aug;76(2):99-103.
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Author Interview: Dr. Martin Wagner, MD MS
Endogenous erythropoietin and the association with inflammation and mortality in diabetic chronic kidney disease.
Wagner M, Alam A, Zimmermann J, Rauh K, Koljaja-Batzner A, Raff U, Wanner C, Schramm L.
Clin J Am Soc Nephrol. 2011 Jul;6(7):1573-9.
University Hospital Würzburg, Department of Medicine I, Division of Nephrology, Zentrum Innere Medizin, Oberdürrbacher Strasse 6, 7080 Würzburg, Germany.
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| FDA Modifies ESA Anemia Drug Recommendations due to Safety Concerns 6/24/11 |
| JAMA: Safety Concerns Prompt New Recommendations for Anemia Drugs |
| HIGH DOSES OF EPOETIN THERAPY DO NOT LOWER MORTALITY AND CARDIOVASCULAR RISK AMONG DIALYSIS PATIENTS WITH DIABETES |
| FDA Response to MTPPI Request re ESA: Black Box Warning |
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Authors Interview:
Marie-Hélène Lafeuille, Robert A. Bailey, Mekré Senbetta, Patrick Lefebvre
Comparison of Epoetin Alfa and Darbepoetin Alfa Dosing Patterns and Costs in a CKD Population Treated in the Hospital Inpatient and Outpatient Setting
Marie-Hélène Lafeuille, Robert A. Bailey, Mekré Senbetta, Patrick Lefebvre
1Groupe d’analyse, Ltée, Montréal, Québec, Canada;
2Centocor Ortho Biotech Services, LLC, Horsham, PA, USA
Presented at the Spring 2011 National Kidney Foundation Meeting |
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Author Interview: Dr. Jacques Rottembourg:
An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months.
Clin Nephrol. 2011 Mar;75(3):242-50.
Rottembourg JB, Bridges I, Pronai W, Feriani M, McMahon LP, De Meester JM, Farouk M, Molemans B. |
Curr Opin Nephrol Hypertens. 2010 Dec 13.
Parfrey PS.
Division of Nephrology, Health Sciences Centre, Memorial University, St John's, Newfoundland and Labrador, Canada.
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Hemodial Int. 2010 Dec 7. doi: 10.1111/j.1542-4758.2010.00508.x.
Muirhead N, Keown PA, Churchill DN, Poulin-Costello M, Gantotti S, Lei L, Gitlin M, Mayne TJ.
London Health Sciences Centre, University Hospital, University of Western Ontario, London, Ontario, Canada Departments of Medicine and Immunology, Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada Amgen Canada Inc., Mississauga, Ontario, Canada Amgen Canada Inc., Mississauga, Ontario, Canada Amgen Inc., Thousand Oaks, California, USA DaVita Inc., El Segundo, California, USA.
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Cardiovasc Ther. 2010 Oct 26.
doi: 10.1111/j.1755-5922.2010.00240.x.
Lipšic E, Van Der Meer P, Van Veldhuisen DJ.
Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
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Published online ahead of print October 25, 2010
CMAJ 10.1503/cmaj.100347
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Nat Rev Nephrol. 2010 Oct 19.
Besarab A, Coyne DW.
Division of Nephrology and Hypertension, Henry Ford Hospital, CFP 511, 2799 West Grand Boulevard, Detroit, MI 48301
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N Engl J Med 2010; 363:1146-1155 September 16 2010
Scott D. Solomon, M.D., Hajime Uno, Ph.D., Eldrin F. Lewis, M.D., M.P.H., Kai-Uwe Eckardt, M.D., Julie Lin, M.D., M.P.H., Emmanuel A. Burdmann, M.D., Ph.D., Dick de Zeeuw, M.D., Ph.D., Peter Ivanovich, M.D., Andrew S. Levey, M.D., Patrick Parfrey, M.D., Giuseppe Remuzzi, M.D., Ajay K. Singh, M.D., Robert Toto, M.D., Fannie Huang, M.S., Jerome Rossert, M.D., Ph.D., John J.V. McMurray, M.D., and Marc A. Pfeffer, M.D., Ph.D. for the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators
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Consult Pharm. 2010 Aug;25(8):493-500.
Lafeuille MH, Bailey RA, Vekeman F, Kilpatrick BS, Senbetta M, Piech CT, Lefebvre P.
Groupe d'analyse, Ltée, Montréal, Québec, Canada.
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Del Vecchio L, Cavalli A, Tucci B, Locatelli F.
Curr Opin Investig Drugs. 2010 Sep;11(9):1030-8.A Manzoni Hospital, Department of Nephrology, Dialysis and Renal Transplant, Via dell'Eremo 9, 23900 Lecco, Italy.
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online at http://jasn.asnjournals.org/ on
August 26, 2010, doi 10.1681/ASN.2009101017.
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Kidney Int. 2010 Jul;78(2):215-23.
McFarlane PA, Pisoni RL, Eichleay MA, Wald R, Port FK, Mendelssohn D.
Division of Nephrology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
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Curr Opin Nephrol Hypertens. 2010 Aug 4.
Singh AK.
Renal Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
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Clin J Am Soc Nephrol. 2010 Jul 29.
Gaweda AE, Nathanson BH, Jacobs AA, Aronoff GR, Germain MJ, Brier ME.
University of Louisville, Louisville, Kentucky;
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Van Wyck DB, Alcorn H Jr, Gupta R.
Am J Kidney Dis. 2010 Jul 15.
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Agarwal AK, Singh AK.
Division of Nephrology, The Ohio State University, 395 West 12th Avenue, Ground Floor, Columbus, OH 43210
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Hsu SP, et al
Department of Internal Medicine, Far Eastern Memorial Hospital,Taipei, Taiwan.
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Spiegel BM, Bolus R, Desai AA, Zager P, Parker T, Moran J, Bolus S, Solomon MD, Khawar O, Gitlin M, Sul H, Talley J, Nissenson A.
Department of Medicine, VA Greater Los Angeles Healthcare System
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Author Interviews: hemodialysis
- Dialysis - ESRD - CKD |
| Predictors of eGFR Decline in Type 2 Diabetes & Preserved Kidney Function: Dr. Chonchol CJASN |
| Tenecteplase for improvement of blood flow in dysfunctional hemodialysis catheters: Dr. Goldman Clin Neph |
| Religious coping, psychological distress and quality of life in hemodialysis: Dr. Carvalho J Psychosom Res. |
| Effect of captopril on recuperation from ischemia/reperfusion-induced AKI Nephrology Dialysis Transplant |
| Restless legs syndrome in dialysis: comparison of hemodialysis & CAPD: Dr. Merlino Neurol Sci. |
| International practice patterns & non-conventional hemodialysis utilization : Dr. Sood BMC Nephrology |
| Decreased PON1 in hemodialyzed & renal transplanted patients. Dr. Paragh Nephrol. Dial. Transplant |
| Preoperative Proteinuria & Long-Term Progression to Chronic Dialysis & Mortality after CABG: Drs. Chao & Ko : PLoS ONE |
| Creatinine generation is reduced in CVHD & predicts mortality: Dr. Wilson: Nephrology Dialysis Transplant |
Importance of normohydration for the long-term survival in hemodialysis : Dr. Wabel
Nephrology Dialysis Transplant |
| Local Tissue Renin-Angiotensin System Activation in Cardiorenal Metabolic Syndrome & Type 2 Diabetes: Dr.Hayden Cardiorenal Med |
| Group I nonreciprocal inhibition in restless legs syndrome secondary to CKD : Dr. Marconi Parkinsonism & Related Disorders |
Low-Dose ESAs and CV Geometry in CKD: Is Darbepoetin-α More Effective than Expected? Dr. Di Lullo
Cardiorenal Med |
Pharmacotherapy to improve outcomes in vascular access surgery: Dr. Jackson
Nephrology Dialysis Transplant |
| Parathyroidectomy for the attainment of NKF-K/DOQI™ and KDIGO recommended values for bone & mineral metabolism in dialysis with uncontrollable secondary hyperparathyroidism. Langenbecks Arch Surg |
| Bisphosphonate Therapy, Death, and Cardiovascular Events Among Female Patients With CKD: Dr. Perkins |
| Losartan prevents the development of the pro-inflammatory monocytes CD14+CD16+ in hemodialysis : Dr. Merino Nephrology Dialysis Transplant |
| Does Dialysis Modality Influence the Oxidative Stress of Uremia? Dr. Capusa Kidney Blood Press Res |
| Treatment of Periodontal Diseases Reduces Inflammation in Hemodialysis : Dr. Siribamrungwong |
| Declining Rates of Deceased Donor Renal Transplantation in the US Over Successive Years of Listing: Dr. Trivedi |
| When Is the Best Moment to Assess the Ankle Brachial Index: Pre- or Post-Hemodialysis?Dr. RM Elias |
| Role of Race and Poverty on Steps to Kidney Transplantation in the Southeastern US |
| Validity & Reliability of the MUST and MST Nutrition Screening Tools in Renal Inpatients : C. Lawson |
| Target-Orientated Algorithm for Regional Citrate-Calcium Anticoagulation in Extracorporeal Therapies: Dr. Brandl |
| Evaluation of bone microarchitecture by HR-pQCT in hemodialysis : Dr. Negri |
| Erectile Dysfunction in Chronic Hemodialysis : Dr. Strippoli |
| Have Renal Dietitians Successfully Implemented Evidence-Based Guidelines Into Practice? E. Joy |
| Regional Citrate Versus Heparin Anticoagulation for CRRT: Drs. Tam & Wu |
| von Willebrand factor predicts mortality in CRRT : Dr. Péquériaux |
| Clinical Outcome of Twice-Weekly Hemodialysis Patients in Shanghai | Dr. Qian |
| Persistently low intact PTH levels predict aortic arch calcification progression in hemodialysis patients : Dr. Song |
| Lack of Awareness among Future Medical Professionals about the Risk of Consuming Hidden Phosphate-Containing Processed Food & Drinks : Dr. Razzaque |
| 51Cr-EDTA plasma & urinary clearance as a measure of residual renal function in dialysis :Dr. Kjaergaard |
| Obesity and Mortality Risk among Younger Dialysis Patients: Dr. Hoogeveen |
| Solar-Assisted Hemodialysis: Dr. Agar |
| Hydrogen sulfide inhibits high glucose-induced matrix protein synthesis by activating AMP-activated protein kinase in renal epithelial cells Drs. Lee & Kasinath |
| Mineral, bone disorders, survival in hemodialysis with & without PKD : Drs. Molnar & Kalantar-Zadeh |
| Hydrogen sulfide inhibits high glucose-induced matrix protein synthesis by activating AMP-activated protein kinase in renal epithelial cells Drs. Lee & Kasinath |
| Mineral, bone disorders, survival in hemodialysis with & without PKD : Drs. Molnar & Kalantar-Zadeh |
| Downregulation of the renal & hepatic hydrogen sulfide-producing enzymes and capacity in CKD - Dr. Vaziri |
| A predictive algorithm for management of anemia in hemodialysis based on ESA pharmacodynamics : Dr. Lines |
| Factors Associated With Intradialytic Systolic Blood Pressure Variability: Dr. Flythe |
| Safety and predictors of complications of renal biopsy in the outpatient setting : Dr. Jiang |
| Heparin induced antibodies in chronic hemodialysis patients and cardiac surgery patients: Dr. Shavit |
| Atrial Fibrillation in Medicare/Medicaid-eligible dialysis patients: Dr. Wetmore |
| Newly identified anorexigenic adipokine nesfatin-1 in hemodialysis patients: J. Saldanha |
| Correction of Post kidney Transplant Anemia Reduces Progression of Allograft Nephropathy: Dr. Choukrou |
| Mild and moderate pre-dialysis CKD is associated with increased coronary artery calcium: Dr. Budoff |
| Endogenous factors modified by hemodialysis and accuracy of blood glucose-measuring device: Dr. Ogawa |
| Narrow-band UVV increases serum vitamin D levels in hemodialysis patients Dr. Ala-Houhala |
| Predicting hospital cost in CKD patients through blood chemistry values: Dr. Bessette |
| Nutritional vitamin D supplementation in hemodialysis: a potential vascular benefit? D. Mason |
| Volume excess in chronic hemodialysis effects of treatment frequency & treatment spacing : Dr. Schneditz |
| Acid reduction with fruits/veges or bicarb attenuates kidney injury in hypertensive nephropathy with reduced GFR |
Predicting Number of US Medical Graduates Entering Adult Nephrology Fellowships
Using Search Terms Dr. Desai |
| Potential influence of sevelamer hydrochloride on responsiveness to ESAs in hemodialysis patients: Dr. Ikee |
| Anemia Management in Dialysis : ESAs vs Transfusions: Clinical & Economic Consequences :Dr. Naci |
| Increased risk of death and de novo chronic kidney disease following reversible acute kidney injury: Dr. Perkins |
| Filtration Markers May Have Prognostic Value Independent of Glomerular Filtration Rate : Dr. Tangri |
| Stopping Renin-Angiotensin System Inhibitors in Chronic Kidney Disease: Predictors of Response |
| Insights into nephrologist training, clinical practice, and dialysis choice: Dr. Mehrotra |
| Early ACE inhibition in Alport syndrome delays renal failure and improves life expectancy: Dr. Gross |
| Blunted insulinemia using high dialysate glucose concentration during hemodialysis : Dr. Schneditz |
| Prevalence of Inadequate Platelet Inhibition by Clopidogrel in Patients Receiving Hemodialysis: Dr. Alexopoulos |
| Live kidney donation: attitudes towards donor approach, motives and factors promoting donation: Dr. Mazaris |
| High-dose ESAs, inflammatory biomarkers, and soluble erythropoietin receptors : Dr. Inrig |
| Association of AKI with Adverse Outcomes in Burned Military Casualties : Dr. Stewart |
| Sodium Intake, ACE Inhibition, and Progression to ESRD Dr. Ruggenenti |
DOPPS Practice Monitor: Update on Trends in US Hemodialysis Care Following Launch of Bundled Payment System and Revisions to ESA Labels January 6 2011 |
Emerging trends in hemodialysis care through August 2011, based on a sample of US dialysis facilities, are included in the latest update to the DOPPS Practice Monitor (DPM, at http://www.dopps.org/DPM), run by the Dialysis Outcomes and Practice Patterns Study (DOPPS) at Arbor Research Collaborative for Health.
Ongoing Changes in the US Dialysis Environment – Recent changes in dialysis payment and regulatory guidance are expected to affect hemodialysis practice. In January 2011, the Centers for Medicare & Medicaid Services (CMS) launched a new Prospective Payment System (PPS) with the intent to control dialysis costs through bundled payments. In June 2011, the FDA approved revised prescribing information for erythropoiesis-stimulating agents (ESAs), used to treat anemia in most dialysis patients. Previously, the label recommended a hemoglobin target range of 10-12 g/dL. The June 2011 update removed the target range, advising instead to start ESA therapy for dialysis patients at hemoglobin less than 10 g/dL, and to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL.
Most Recent Trends in Care – Over the August 2010 to August 2011 time period, many hemodialysis practices have remained stable; examples include nutrition measures and hemodialysis treatment time and dose. There have been notable trends in the following practice areas:
- Anemia: Hemoglobin levels have decreased since the June 2011 ESA label update. While the mean hemoglobin level declined by 0.12 g/dL over 12 months from August 2010 to July 2011, it declined in August 2011 by another 0.10 g/dL to 11.26 g/dL. The percentage of patients with hemoglobin levels greater than 12 g/dL declined sharply (from 28% to 23%) in July/August 2011, while the percentage with hemoglobin levels less than 10 g/dL increased slightly from 8.5% to 10% and the percentage with hemoglobin levels less than 9 g/dL remained under 3%.
Mean prescribed epoetin dose (among patients receiving epoetin) decreased by 15%, from 21,100 units/wk to 17,900 units/wk, from August 2010 to August 2011, with the greatest decline in June-August 2011. Epoetin doses at the higher end of the dose range have decreased most notably. IV iron use increased from August 2010 to August 2011 though has recently stabilized. In keeping with greater IV iron use, serum ferritin levels (indicative of iron stores) continue to rise. Serum ferritin concentration exceeded 500 ng/mL in 65% of patients, 800 ng/mL in 34% of patients, and 1,200 ng/mL in 11% of patients in August 2011.
- Mineral & Bone Disorder: In our last report, we noted a 29% increase in serum parathyroid hormone (PTH) levels through April 2011, and differences by race were described. Since then, PTH levels have remained stable or declined slightly in both black and non-black patients. In August 2011, 22% of black patients and 12% of non-black patients had very high PTH values (defined here as PTH >600 pg/mL). The percentage of hemodialysis patients for whom PTH is measured has declined slightly since August 2010. There have been no clear changes in serum calcium or serum phosphorus levels.
- Clinical Outcomes: Preliminary data indicate that the 30-day hospitalization rate has increased somewhat from August 2010 to August 2011. The DPM does not report yet on trends in red blood cell transfusions, as dialysis units are often unaware of transfusions occurring in the inpatient setting. Additional efforts to comprehensively monitor trends in transfusions are warranted. To date mortality rate has not changed appreciably, though further follow-up time is necessary as we continue to track this outcome.
Future monitoring of these trends, confirmation with national data when eventually available, and understanding their effect on clinical outcomes, if any, is required.
DPM data are aggregated across dialysis organizations and facilities. Aggregated trends may not reflect trends in individual dialysis organizations or facilities, and are not intended to provide oversight of performance in individual dialysis organizations or facilities.
Read the rest of the DOPPS Practice Monitor: Update on Trends in US Hemodialysis Care Following Launch of Bundled Payment System and Revisions to ESA Labels Press Release |
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Hemodialysis Research Interview of the Week |
Author Interview: Dr. Len Usvyat PhD
Clinical Systems Database Senior Analyst
Renal Research Institute
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Seasonal Variations in Mortality, Clinical, and Laboratory Parameters in Hemodialysis Patients: A 5-Year Cohort Study.
Usvyat LA, Carter M, Thijssen S, Kooman JP, van der Sande FM, Zabetakis P,
Balter P, Levin NW, Kotanko P.
Clin J Am Soc Nephrol. 2011 Nov 17.
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What are the main findings of the study? |
We found that mortality of hemodialysis patients followed a seasonal pattern over a five year period with the highest mortality in the winter and lowest mortality in the summer months.
We also observed that many clinical and laboratory parameters follow a seasonal pattern in our patient population.
For example, pre-dialysis systolic blood pressures are highest in winter and lowest in summer months; pre-dialysis body temperatures are highest in summer and lowest in winter months.
Neutrophils are highest in winter and lowest in summer suggesting higher inflammatory markers in the winter.
This phenomena was observed in various geographic regions in US.
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Were any of the findings unexpected? |
It has been previously shown that mortality follows seasonal trends in healthy population however these findings were never extended to dialysis patients.
While it was shown that blood pressures tend to follow a seasonal pattern, to the best of our knowledge, it has not been shown that neutrophils or interdialytic weight gains also follow a seasonal pattern.
Additionally, we applied a cosinor analysis to show whether these patterns are statistically significant.
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What should clinicians and patients take away from this study? |
These findings are particularly important in designing studies -- taking season into account is key.
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What recommendations do you have for future studies as a result of your study? |
Further research into understanding the biologic factors that contribute to this seasonality is important.
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