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12.08.2013
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Am J Kidney Dis 2001;37 (suppl 1): S 182
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c Erslev & Beutler. In: Williams’ Hematology. 5th ed. 1995;425-441
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“
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. Serum erythropoietin concentration in chronic renal failure: relationship to degree of anemia and excretory renal function. Blood. 1979;54(4):877-884.
,
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Y. Cao Erythropoietin in cancer: a dilemma in risk therapy. Trends in Endocrinology & Metabolism, Volume 24, Issue 4, April 2013, 190-199; Murat O. Arcasoy Non-erythroid effects of
erythropoietin Haematologica November 2010 95: 1803-1805
3
12.08.2013
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K. Kalantar-Zadeh, Intravenous Iron Versus Erythropoiesis-Stimulating Agents: Friends or Foes in Treating Chronic Kidney Disease Anemia? Advances in Chronic
Kidney Disease, Volume 16, Issue 2, March 2009, Pages 143-151
< 13
< 12
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)
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, 1968 .
< 13,5 -13,2
;
< 12,0
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KDIGO,2012
ERBP, 2013
Nutritional anaemias. (1968). Report of a WHO scientific group. World Health Organ Tech Rep Ser, 405, 5-37,
Robinson, B. E. (2006). Epidemiology of chronic kidney disease and anemia. J Am Med Dir Assoc ; S17-21; Bellizzi, V. Influence of the cyclic variation of hydration status on
hemoglobin levels in hemodialysis patients. Am J Kidney Dis PMID: 12200807 S0272-6386(02)00080-X[pii]10.1053/ajkd.2002.34913 , 40(3), 549-555.
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12.08.2013
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Hb
1
32
50%
3–5
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(QoL)
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6
1.
Astor et al. Arch Intern Med. 2002;162:1401-1408
2. Thorp et al. Dis Manag. 2006;9:115-121
3. McClellan et al. Curr Med Res Opin. 2004;20:1501-1510
3. Locatelli et al. Nephrol Dial Transplant. 2004;19:121-132
4. Silverberg. Nephrol Dial Transplant. 2003;18(Suppl 2):ii7-12
5. Perlman et al. Am J Kidney Dis. 2005; 45:658-666
•
•
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•
1
(QoL)2
3
4,5
6
7
1.
4.
Eschbach JW
. Ann Intern Med1989;111:992-1000;
2. Evans RW
, JAMA1990;263:825-830
3. Marsh JT
. Kidney Int 1991;39:155-163
Cannella G
, Nephrol Dial Transplant 1991;6:31-37
5. Pascual J
. Clin Nephrol1991;35:280-287
6. Braumann KM
, Nephron1991;58:129-134
7. Veys N
. Am J Kidney Dis 1992;19:358-363
5
12.08.2013
KDOQI
11-12
DOQI
11-12
1997
1999
EBPG
> 11
2001
2004
EBPG
>11
2006 2007
2009
2012
2013
)
Besarab A. What Is So Bad About a Hemoglobin Level of 12 to 13 g/dL for Chronic Kidney Disease Patients Anyway? Advances in Chronic Kidney Disease,16,2,2009,131-142
= 3028
/1,73
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2
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Levin et al. Nephrol Dial Transplant. 2006;21:370-377
6
12.08.2013
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= 4591
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Locatelli et al. Nephrol Dial Transplant. 2004;19:121-132
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,
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,
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Pisoni et al. Am J Kidney Dis. 2004;44:94-111
7
12.08.2013
US Normal Hematocrit trial:
,
N=1233
(%)
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Ht
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)
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Besarab A. et al N Engl J Med 1998; 339: 584-90, FDA CDRAC Briefing Document 2007
CREATE: The Cardiovascular risk reduction by
early anemia treatment with epoetin beta
Drüeke TB et al. N Engl J Med 2006;355:2071–84
8
12.08.2013
CREATE:
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80
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60
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=0,78 (0,53–1,14)
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30
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10
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1
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0
6
12
18
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36
42
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Drüeke et al. N Engl J Med. 2006;355:2071-2084
CHOIR: Correction of Hemoglobin and Outcomes
in Renal Insufficiency
Singh AK et al. N Engl J Med 2006;355:2085–98
9
12.08.2013
CHOIR:
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Hb 11,3
,
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3-4
Hb 13.5
Hb 11.3
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: 125 vs. 97
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0.05
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1
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594
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Singh et al. N Engl J Med. 2006;355:2085-2098
TREAT:
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80
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60
50
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40
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2012
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Pfeffer MA et al. N Engl Med 2009;361:2019–32
10
12.08.2013
US NHCT 1
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N=1233
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:
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1 Besarab A. et al N Engl J Med 1998; 339: 584-90; 2 Drüeke TB et al. N Engl J Med 2006;355:2071–84; 3 Singh AK et al. N Engl J Med 2006;355:2085–98; 4 Pfeffer MA et al. N Engl Med 2009;361:2019–32
Ann Intern Med. 2010;153(1):23-33. doi:10.7326/0003-4819-153-1-201007060-00252
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12.08.2013
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13
2012
2013
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Besarab A. What Is So Bad About a Hemoglobin Level of 12 to 13 g/dL for Chronic Kidney Disease Patients Anyway? Advances in Chronic Kidney Disease,16,2,2009,131-142
,
(USRDS)
(JSDT)
Hb,
Hb
Iseki K, Kohagura K Anemia as a risk factor for chronic kidney disease. Kidney international. Supplement 2007 ():S4-S9.
12
12.08.2013
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1997
1999
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2012
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2013
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Besarab A. What Is So Bad About a Hemoglobin Level of 12 to 13 g/dL for Chronic Kidney Disease Patients Anyway? Advances in Chronic Kidney Disease,16,2,2009,131-142
KDOQI
KDOQI
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1997
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KDOQI
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1999
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2001
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2012
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Besarab A. What Is So Bad About a Hemoglobin Level of 12 to 13 g/dL for Chronic Kidney Disease Patients Anyway? Advances in Chronic Kidney Disease,16,2,2009,131-142
13
12.08.2013
,
,
Leaf D.E. Kidney International 2009; 75;15-24
•
•
•
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•
Leaf D.E. Kidney International 2009; 75;15-24, Besarab A. et al N Engl J Med 1998; 339: 584-90, FDA CDRAC Briefing Document 2007; Khuri F. N Engl J Med 2007; 356:2445-2448
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12.08.2013
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Hsu et al, J Am Soc Nephrol 2002;13:2783-86
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Walter H. Horl, Clinical Aspects of Iron Use in the Anemia of Kidney Disease JASN February 2007;18;2;382-393
B. M. Denker Iron Therapy in Chronic Kidney Disease; Nephrology Rounds, 2005;3;5;1-6
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12.08.2013
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Vaulont S, J Clin Invest 2005,115;2079-2082
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Locatelli F. ,NDT 2004;19:1-47; 2. National Kidney Foundation Am J Kidney Dis 2006;47;S11-145; 3.Locatelli F. NDT 2009;24:348-54;
4.KDIGO Kidney Int Suppl 2012;2:292-298; 5. Locatelli F, NDT 2013doi: 10.1093/ndt/gft033
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12.08.2013
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KDIGO Anemia Work Group Kidney Int Suppl 2012;2;292-8
Hb
/
, 95%
%
, 95%
Allegra 1990
13,42
-0,90 [0,04; 1,76]
Fishbane 1995
14,67
1,53 [0,91; 2,15]
MacDougall 1996
12,27
1,45 [0,39; 2,51]
Svara 1996
14,97
0,19 [-0,36; 0,74]
Warady 2004
14,07
0,24 [-0,55; 0,50]
Michael 2007
14,98
0,00 [-0,55; 0,50]
Li 2008
15,62
1,99 [1,60; 2,38]
100,00
0,83 [0,09; 1,57]
-4
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0
2
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per os
Rozen-Zvi B, Am J Kidney Dis 2008;52:897-906
17
12.08.2013
Eugene Goldwasser
14.10.1922 – 17.10.2010
165
32-36000
Fishbane S. Curr Opin Nephrol Hypertens. 2009;18;112-115
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12.08.2013
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Macdougall I Clin J Am Soc Nephrol 3: 200-207;2008;
Jelkmann W. Nephrol Dial Transplant (2007) 22: 2749–2753
–
?
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Genentech
Nutropin®
Abbott
Abbokinase®
Eli Lilly
Humulin®
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Ceredase®
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Humatrope®
EPREX®
NeoRecormon®
Genentech
TNKase® (tenecteplase TNK-tPA)
Genentech
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2005
2005, 2006, 2012
),
Actimmune® (IFN- -Ib)
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Chiron
Proleukin® (IL-2)
Amgen
Neupogen®
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J&J
Roche
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Schellekens H. Trends Biotechnol 2004;22:406-10.
19
12.08.2013
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Jelkmann W. Nephrol Dial Transplant (2007) 22: 2749–2753
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1
http://gabi-journal.net/news/biosimilars-marketed-in-europe
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Crommelin DJA, et al. Int J Pharm 2003;266:3-16.
Jelkmann W. Nephrol Dial Transplant (2007) 22: 2749–2753
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H. Mellstedt, D. Niederwieser & H. Ludwig. The challenge of biosimilars.
Annals of Oncology 19: 411–419, 2008
21
12.08.2013
11
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Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: an analysis based on recently implemented European Medicines Evaluation Agency guidelines on comparability of
biopharmaceutical proteins. Pharmacotherapy 2005; 25: 954–962; Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus (2009) 2 [Suppl 1]: i27–i36
® vs
®
®
®; Dynepo® vs Retacrit®)
Retacrit®
Dynepro®
Brinks V. Quality of original and biosimilar epoetin products Pharm Res (2011) 28:386–393
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000725/human_med_000675.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125
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12.08.2013
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12.08.2013
Eugene Goldwasser
14.10.1922 – 17.10.2010
!
26