NN&I - January 2012
Renal Policy safety and availability FDA drug safety communication Modified dosing recommendations to improve the safe use of erythropoiesis stimulating agents esas in chronic kidney disease Washington D C Food and Drug Administration 2011 2 Unger EF FDA perspectives on erythropoiesis stimulating agents ESAs for anemia of chronic renal failure Hemoglobin target and dose optimization FDA Office of Surveillance and Epidemiology OSE and Center for Drug Evaluation and Research CDER 2007 3 Lacson E Ofsthun N Lazarus JM Effect of variability in anemia management on hemoglobin outcomes in ESRD Am J Kidney Dis 41 1 111 24 2003 4 Ofsthun N Labrecque J Lacson E Keen M Lazarus JM The effects of higher hemoglobin levels on mortality and hospitalization in hemodialysis patients Kidney Int 63 5 1908 14 2003 5 Regidor DL Kopple JD Kovesdy CP Kilpatrick RD McAllister CJ Aronovitz J et al Associations between changes in hemoglobin and administered erythropoiesis stimulating agent and survival in hemodialysis patients J Am Soc Nephrol 17 4 1181 91 2006 6 Yang W Israni RK Brunelli SM Joffe MM Fishbane S Feldman HI Hemoglobin variability and mortality in ESRD J Am Soc Nephrol 18 12 3164 70 2007 7 Gilbertson DT Ebben JP Foley RN Weinhandl ED Bradbury BD Collins AJ Hemoglobin level variability Associations with mortality Clin J Am Soc Nephrol 3 1 133 8 2008 8 Boudville NC Djurdjev O Macdougall IC de Francisco AL Deray G Besarab A et al Hemoglobin variability in nondialysis chronic kidney disease Examining the association with mortality Clin J Am Soc Nephrol 4 7 1176 82 2009 9 Eckardt KU Kim J Kronenberg F Aljama P Anker SD Canaud B et al Hemoglobin variability does not predict mortality in European hemodialysis patients J Am Soc Nephrol 21 10 1765 75 2010 10 Fort J Cuevas X García F Pérez García R Lladós F Lozano J et al Mortality in incident haemodialysis patients Time Dependent haemoglobin levels and erythropoiesisstimulating agent dose are independent predictive factors in the ANSWER study Nephrol Dial Transplant 25 8 2702 10 2010 11 Pisoni RL Bragg Gresham JL Fuller DS Morgenstern H Canaud B Locatelli F et al Facility Level interpatient hemoglobin variability in hemodialysis centers participating in the dialysis outcomes and practice patterns study DOPPS Associations with mortality patient characteristics and facility practices Am J Kidney Dis 57 2 266 75 2011 12 Molnar MZ Mehrotra R Duong U Kovesdy CP Kalantar Zadeh K Association of hemoglobin and survival in peritoneal dialysis patients Clin J Am Soc Nephrol 6 8 1973 81 2011 13 Regidor D McClellan WM Kewalramani R Sharma A Bradbury BD Changes in erythropoiesis stimulating agent ESA dosing and haemoglobin levels in US non dialysis chronic kidney disease patients between 2005 and 2009 Nephrol Dial Transplant 26 5 1583 91 2011 14 Feinstein AR An additional basic science for clinical medicine II The limitations of randomized trials Ann Intern Med 99 4 544 50 1983 15 Concato J Shah N Horwitz RI Randomized controlled trials observational studies and the hierarchy of research designs N Engl J Med 342 25 1887 92 2000 16 Pollak VE Lorch JA Means RT Unanticipated favorable effects of correcting iron deficiency in chronic hemodialysis patients J Investig Med 49 2 173 83 2001 17 Pollak VE Lorch JA Shukla R Satwah S The importance of iron in long term survival of maintenance hemodialysis patients treated with epoetin alpha and intravenous iron Analysis of 95 years of prospectively collected data BMC Nephrol 10 1 6 2009 18 Lorch JA Pollak VE Prescribing EPO to chronic maintenance HD patients A physiologic approach implemented with continuous quality improvement leads to decreased EPO use and increased hemoglobin Presented at ASN Kidney Week Philadelphia PA November 11 2011 2011 19 The Rogosin Institute Manhattan dialysis centers Annual Dialysis Facility Report July 2010 performance data compared with the State of New York standardized mortality ratio is 23 below New York State standardized mortality ratio in 1st year of dialysis is 38 below standardized hospitalization ratio days is 15 below standardized emergency ratio visits is 44 below hospital days per patient year is 26 below hospital re admissions ratio is 17 below emergency visits per patient year is 42 below admissions from emergency department is 34 below 20 Hampl H Why correct renal anemia completely Clin Nephrol 53 1 Suppl S87 9 2000 21 Schäfer GE Rehbein C Stiegler T Hampl H Renal anemia and its hemodynamic response findings invasively determined over a period of 20 years Clin Nephrol 58 Suppl 1 S52 7 2002 22 Hampl H Sternberg C Berweck S Lange D Lorenz F Pohle C et al Regression of left ventricular hypertrophy in hemodialysis patients is possible Clin Nephrol 58 Suppl 1 S73 96 2002 23 Hampl H Hennig L Rosenberger C Amirkhalily M Gogoll L Riedel E Scherhag A Effects of optimized heart failure therapy and anemia correction with epoetin beta on left ventricular mass in hemodialysis patients Am J Nephrol 25 3 211 20 2005 24 Hampl H Hennig L Rosenberger C Gogoll L Riedel E Scherhag A Proven strategies to reduce cardiovascular mortality in hemodialysis patients Blood Purif 24 1 100 6 2006 25 Hampl H Riedel E Cardiac disease in the dialysis patient Good better best clinical practice Blood Purif 27 1 99 113 2009 26 Besarab A Bolton WK Browne JK Egrie JC Nissenson AR Okamoto DM et al The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin N Engl J Med 339 9 584 90 1998 Nephrology News Issues January 2012 Subscribe to our free eNewsletter at www NephrologyNews com 34
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