Mortality and cardiovascular morbidity associated with haemoglobin levels: A pooled analysis of randomised controlled trials

Nephron - Clinical Practice

Volumn 128, Issue , 2014, Pages 323-332

  Locatelli, Francesco ^a   De Francisco, Angel ^b   Deray, Gilbert ^c   Fliser, Danilo ^d   Armstrong, Gillian ^e   Dougherty, Frank C ^e   Ehrhard, Patricia ^e  

^a A MANZONI HOSPITAL   (Italy)

^b HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^c PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^d SAARLAND UNIVERSITY   (Germany)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Anaemia; Cardiovascular events; Chronic kidney disease; Erythropoiesis stimulating agent; Haemoglobin target; Methoxy polyethylene glycol epoetin beta

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; HEMOGLOBIN; ANTIANEMIC AGENT;

ADULT; ANEMIA; ARTICLE; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; FEMALE; HEART INFARCTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; BLOOD; CARDIOVASCULAR DISEASES; CAUSE OF DEATH; COMPLICATION; DRUG EFFECTS; HEMODIALYSIS; KAPLAN MEIER METHOD; KIDNEY FAILURE, CHRONIC; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR;

CARDIOVASCULAR DISEASES; CAUSE OF DEATH; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; KAPLAN-MEIER ESTIMATE; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENAL DIALYSIS; RISK FACTORS;

EID: 84922913496     PISSN: None     EISSN: 16602110     Source Type: Journal    
DOI: 10.1159/000366478     Document Type: Article

References (31)

1. Locatelli F, Aljama P, Bárány P, Canaud B, Carrera F, Eckardt KU, Horl WH, Macdou-gall IC, Macleod A, Wiecek A, Cameron S: Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004; 19(suppl 2):ii1-ii47.
2. Parfrey PS, Wish T: Quality of life in CKD patients treated with erythropoiesis-stimulating agents. Am J Kidney Dis 2010; 55:423-425.
3. Leaf DE, Goldfarb DS: Interpretation and review of health-related quality of life data in CKD patients receiving treatment for anemia. Kidney Int 2009; 75:15-24.
4. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA: The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemo-dialysis and epoetin. N Engl J Med 1998; 339: 584-590.
5. Parfrey PS, Foley RN, Wittreich BH, Sullivan DJ, Zagari MJ, Frei D: Double-blind comparison of full and partial anemia correction in incident hemodialysis patients without symptomatic heart disease. J Am Soc Nephrol 2005; 16:2180-2189.
6. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators: Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355:2085-2098.
7. Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators: Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355:2071-2084.
8. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Iva-novich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parv-ing HH, Remuzzi G, Singh AK, Solomon SD, Toto R; TREAT Investigators: A trial of dar-bepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009; 361:2019-2032.
9. Szczech LA, Barnhart HX, Inrig JK, Reddan DN, Sapp S, Califf RM, Patel UD, Singh AK: Secondary analysis of the CHOIR trial epoetin-α dose and achieved hemoglobin outcomes. Kidney Int 2008; 74:791-798.
10. Levin NW, Fishbane S, Cañedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D: Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet 2007; 370:1415-1421.
11. Sulowicz W, Locatelli F, Ryckelynck JP, Balla J, Csiky B, Harris K, Ehrhard P, Beyer U: Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007; 2: 637-646.
12. Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gemtholtz T, Ciechanowski K, Dougherty FC, Beyer U: Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis 2007; 50:989-1000.
13. Macdougall IC, Walker R, Provenzano R, de Alvaro F, Locay HR, Nader PC, Locatelli F, Dougherty FC, Beyer U: C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008; 3: 337-347.
14. Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U: Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant 2008; 23:3654-3661.
15. Spinowitz B, Coyne DW, Lok CE, Fraticelli M, Azer M, Dalal S, Villa G, Rosansky S, Ada-mis H, Beyer U: C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks. Am J Nephrol 2008; 28:280-289.
16. Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JFE, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC: Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant 2010; 25:4009-4017.
17. Roger SD, Locatelli F, Woitas RP, Laville M, Tobes SW, Provenzano R, Golper TA, Ruang-kanchanasetr P, Lee HY, Wu K-D, Nowicki M, Ladanyi A, Martinez-Castelao A, Beyer U, Dougherty FC: C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrol Dial Transplant 2011; 26: 3980-3986.
18. US National Institutes of Health, Department of Health and Human Services, National Library of Medicine, ClinicalTrials.gov (NCT00442702): A study of subcutaneous Mircera in patients with chronic kidney disease, not on dialysis. http://clinicaltrials.gov/show/NCT00442702 (accessed May 5, 2014).
19. Furuland H, Linde T, Ahlmén J, Christensson A, Strömbom U, Danielson BG: A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients. Nephrol Dial Transplant 2003; 18:353-361.
20. Palmer SC, Navaneethan SD, Craig JC, Johnson DW, Tonelli M, Garg AX, et al: Meta-Analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med 2010; 153:23-33.
21. Unger EF, Thompson AM, Blank MJ, Temple R: Erythropoiesis-stimulating agents-time for a reevaluation. N Engl J Med 2010; 362: 189-192.
22. Locatelli F, Aljama P, Canaud B, Covic A, De Francisco A, Macdougall IC, Wiecek A, Van-holder R; Anaemia Working Group of European Renal Best Practice: Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) study. Nephrol Dial Transplant 2010; 25:2846-2850.
23. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease. 2011. http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm (accessed September 28, 2012).
24. Kidney Disease Improving Global Outcomes Anemia Work Group: KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl 2012; 2:279-335.
25. Regidor DL, Kopple JD, Kovesdy CP, Kilpat-rick RD, McAllister CJ, Aronovitz J, Greenland S, Kalantar-Zadeh K: Associations between changes in hemoglobin and administered erythropoiesis-stimulating agent and survival in hemodialysis patients. J Am Soc Nephrol 2006; 17:1181-1191.
26. Macdougall IC, Tomson CRV, Steenkamp M, Ansell D: Relative risk of death in UK haemo-dialysis patients in relation to achieved haemoglobin from 1999 to 2005: an observational study using UK Renal Registry data incorporating 30, 040 patient-years of follow-up. Nephrol Dial Transplant 2010; 25:914-919.
27. Gilbertson DT, Ebben JP, Foley RN, Wein-handl ED, Bradbury BD, Collins AJ: Hemoglobin level variability: associations with mortality. Clin J Am Soc Nephrol 2008; 3:133-138.
28. Portoles J, Lopez-Gomez JM, Aljama P: A prospective multicentre study of the role of anaemia as a risk factor in haemodialysis patients: the MAR study. Nephrol Dial Transplant 2007; 22:500-507.
29. Fort J, Cuevas X, García F, Perez-Garcia R, Llados F, Lozano J, Martin-Malo A: Mortality in incident haemodialysis patients: time-dependent haemoglobin levels and erythropoie-sis-stimulating agent dose are independent predictive factors in the ANSWER study. Nephrol Dial Transplant 2010; 25:2702-2710.
30. Skali H, Parving HH, Parfrey PS, Burdmann EA, Lewis EF, Ivanovich P, Keithi-Reddy SR, McGil JB, McMurray JJV, Singh AK, Solomon SD, Uno H, Pfeffer MA; TREAT Investigators: Stroke in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia treated with darbepoetin alfa: the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) experience. Circulation 2011; 124:2903-2908.
31. Locatelli F, Bárány P, Covic A, De Francisco A, Del Vecchio L, Goldsmith D, Hörl W, London G, Vanholder R, Van Biesen W; ERA-EDTA ERBP Advisory Board: Kidney Disease Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European renal best practice position statement. Nephrol Dial Transplant 2013; 28: 1346-1359.