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

Volumn 124, Issue 25, 2011, Pages 2903-2908

  Skali, Hicham ^a   Parving, Hans Henrik ^c,d   Parfrey, Patrick S ^e   Burdmann, Emmanuel A ^f   Lewis, Eldrin F ^a   Ivanovich, Peter ^g   Keithi Reddy, Sai Ram ^h   McGill, Janet B ⁱ   McMurray, John J V ^a,j   Singh, Ajay K ^b   Solomon, Scott D ^a   Uno, Hajime ^a   Pfeffer, Marc A ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b Renal Division   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF COPENHAGEN   (Denmark)

^e Health Sciences Centre St John's   (Canada)

^f UNIVERSITY OF SÃO PAULO   (Brazil)

^g NORTHWESTERN UNIVERSITY   (United States)

^h AMGEN INC   (United States)

ⁱ WASHINGTON UNIVERSITY   (United States)

^j UNIVERSITY OF GLASGOW   (United Kingdom)

more..

Author keywords

Anemia; diabetes mellitus; Erythropoietin; Kidney diseases; Risk; Stroke

Indexed keywords

ANTIVITAMIN K; HEMOGLOBIN; INSULIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PLACEBO;

AGED; ANEMIA; BLOOD PRESSURE; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; STROKE; THROMBOCYTE COUNT;

AGED; ANEMIA; CASE-CONTROL STUDIES; DIABETES MELLITUS, TYPE 2; ERYTHROPOIETIN; FEMALE; FOLLOW-UP STUDIES; HEMATINICS; HUMANS; INCIDENCE; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY, CHRONIC; RISK FACTORS; RISK REDUCTION BEHAVIOR; STROKE; TREATMENT OUTCOME;

EID: 84155164794     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.111.030411     Document Type: Review

References (26)

1. Sarnak MJ, Tighiouart H, Manjunath G, MacLeod B, Griffith J, Salem D, Levey AS. Anemia as a risk factor for cardiovascular disease in the Atherosclerosis Risk in Communities (ARIC) study. J Am Coll Cardiol. 2002;40:27-33. (Pubitemid 34701373)
2. Ezekowitz JA, McAlister FA, Armstrong PW. Anemia is common in heart failure and is associated with poor outcomes: insights from a cohort of 12 065 patients with new-onset heart failure. Circulation. 2003;107: 223-225. (Pubitemid 36135214)
3. Li S, Collins AJ. Association of hematocrit value with cardiovascular morbidity and mortality in incident hemodialysis patients. Kidney Int. 2004;65:626-633. (Pubitemid 38130658)
4. Go AS, Yang J, Ackerson LM, Lepper K, Robbins S, Massie BM, Shlipak MG. Hemoglobin level, chronic kidney disease, and the risks of death and hospitalization in adults with chronic heart failure: The Anemia in Chronic Heart Failure: Outcomes and Resource Utilization (ANCHOR) study. Circulation. 2006;113:2713-2723. (Pubitemid 43947989)
5. O'Meara E, Clayton T, McEntegart MB, McMurray JJV, Lang CC, Roger SD, Young JB, Solomon SD, Granger CB, Ostergren J, Olofsson B, Michelson EL, Pocock S, Yusuf S, Swedberg K, Pfeffer MA, CHARM Committees and Investigators. Clinical correlates and consequences of anemia in a broad spectrum of patients with heart failure: results of the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) program. Circulation. 2006;113:986-994. (Pubitemid 43879474)
6. Giraldez RR, Sabatine MS, Morrow DA, Mohanavelu S, McCabe CH, Antman EM, Braunwald E. Baseline hemoglobin concentration and creatinine clearance composite laboratory index improves risk stratification in ST-elevation myocardial infarction. Am Heart J. 2009;157:517-524.
7. Groenveld HF, Januzzi JL, Damman K, van Wijngaarden J, Hillege HL, van Veldhuisen DJ, van der Meer P. Anemia and mortality in heart failure patients: a systematic review and meta-analysis. J Am Coll Cardiol. 2008;52:818-827.
8. Vlagopoulos PT, Tighiouart H, Weiner DE, Griffith J, Pettitt D, Salem DN, Levey AS, Sarnak MJ. Anemia as a risk factor for cardiovascular disease and all-cause mortality in diabetes: the impact of chronic kidney disease. J Am Soc Nephrol. 2005;16:3403-3410. (Pubitemid 46179344)
9. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJV, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R, TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361:2019-2032.
10. Mix TC, Brenner RM, Cooper ME, de Zeeuw D, Ivanovich P, Levey AS, McGill JB, McMurray JJ, Parfrey PS, Parving HH, Pereira BJ, Remuzzi G, Singh AK, Solomon SD, Stehman-Breen C, Toto RD, Pfeffer M.A. Rationale-Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease. Am Heart J. 2005;149:408-413. (Pubitemid 40585402)
11. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill J, McMurray JJV, Parfrey P, Parving H-H, Remuzzi G, Singh AK, Solomon SD, Toto R, Uno H, TREAT Investigators. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). Am J Kidney Dis. 2009;54:59-69.
12. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94:496-509.
13. Newson R. Confidence intervals for rank statistics: percentile slopes, differences, and ratios. Stata J. 2006;6:497-520.
14. Vaziri ND. Cardiovascular effects of erythropoietin and anemia correction. Curr Opin Nephrol Hypertens. 2001;10:633-637. (Pubitemid 32783813)
15. Raine AE. Hypertension, blood viscosity, and cardiovascular morbidity in renal failure: implications of erythropoietin therapy. Lancet. 1988;1: 97-100.
16. Dallongeville J, Bhatt DL, Steg PG, Ravaud P, Wilson PW, Eagle KA, Goto S, Mas JL, Montalescot G. Relation between body mass index, waist circumference, and cardiovascular outcomes in 19 579 diabetic patients with established vascular disease: The REACH Registry. Eur J Cardiovasc Prev Rehabil. Published ahead of print, February 25, 2011. DOI:10.1177/1741826710394305. http://cpr.sagepub.com/content/early/ 2011/02/24/1741826710394305.full.pdf-html. Accessed November 1, 2011.
17. Vemmos K, Ntaios G, Spengos K, Savvari P, Vemmou A, Pappa T, Manios E, Georgiopoulos G, Alevizaki M. Association between obesity and mortality after acute first-ever stroke: the obesity-stroke paradox. Stroke. 2011;42:30-36.
18. Raine AE, Roger SD. Effects of erythropoietin on blood pressure. Am J Kidney Dis. 1991;18:76-83.
19. Unger EF, Thompson AM, Blank MJ, Temple R. Erythropoiesisstimulating agents: time for a reevaluation. N Engl J Med. 2010;362: 189-192.
20. Vaziri ND, Zhou XJ. Potential mechanisms of adverse outcomes in trials of anemia correction with erythropoietin in chronic kidney disease. Nephrol Dial Transplant. 2009;24:1082-1088.
21. 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 hemodialysis and epoetin. N Engl J Med. 1998;339:584-590. (Pubitemid 28385655)
22. Ghezzi P, Bernaudinb M, Bianchic R, Blomgren K. Erythropoietin: not just about erythropoiesis. Lancet. 2010;375:2142.
23. Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, Schellinger PD, Bohn M, Becker H, Wegrzyn M, Jähnig P, Herrmann M, Knauth M, Bähr M, Heide W, Wagner A, Schwab S, Reichmann H, Schwendemann G, Dengler R, Kastrup A, Bartels C, EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke. 2009;40:e647-e656.
24. Solomon SD, Uno H, Lewis EF, Eckardt KU, Lin J, Burdmann EA, de Zeeuw D, Ivanovich P, Levey AS, Parfrey P, Remuzzi G, Singh AK, Toto R, Huang F, Rossert J, McMurray JJ, Pfeffer M.A. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med. 2010;363:1146-1155.
25. 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. (Pubitemid 41716451)
26. Pfeffer MA, Skali H. Can there be any surrogate for safety? Dialogues Cardiovasc Med. 2010;15:130-139.