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Anemia Guidelines and The Use of Erythropoietin in Turkey Kenan ATEŞ, MD Department of Nephrology Ankara University Faculty of Medicine.

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Presentation on theme: "Anemia Guidelines and The Use of Erythropoietin in Turkey Kenan ATEŞ, MD Department of Nephrology Ankara University Faculty of Medicine."— Presentation transcript:

1 Anemia Guidelines and The Use of Erythropoietin in Turkey Kenan ATEŞ, MD Department of Nephrology Ankara University Faculty of Medicine

2 Anemia in chronic renal failure GFR <40 ml/min ANEMİA Normocytic normochromic Normocytic normochromic Erythropoietin deficiency Iron deficiency Folate/Vitamin B 12 deficiency Inflammation Aluminium overload Blood loss Hemolysis Erythropoesis inhibition

3 Anemia is important Decreased tissue oxygen delivery and utilization Increased cardiac output Ventricular hypertrophy Cardiac enlargement Angina pectoris Congestive heart failure Decreased cognition and mental acuity Altered menstrual cycles Decreased sexual function Impaired immune responsiveness Growth retardation Decreased intellectual performance Reduced quality of life Decreased survival Poor patient rehabilitation

4 Treatment of anemia Adequate dialysis Adequate nutrition Treatment of secondary hyperparathyroidism Prevention of inflammation Iron supplementation Target Hb/Hct Level ERYTHROPOIETIN

5 Not all dialysis patients will require treatment with EPO HD PD 20% 40% Adequate dialysis Adequate nutrition Iron supplementation Other measures

6 C O S T EPO therapy is a very expensive treatment One month cost HEMODIALYSIS HEMODIALYSIS 900 $ EPO (6000 U/wk) EPO (6000 U/wk) 500 $

7 ANEMIA GUIDELINES

8 Anemia Guidelines The aim of guidelines is to provide an evidence-based standard of care for management of anemia in patients with chronic renal failure NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES

9 When to initiate the work-up of anemia Hb <11 g/dl (Hct <33%) Pre-menopausal females Pre-pubertal patients Post-menopausal females Adult males Hb <12 g/dl (Hct <37%) NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES

10 Evaluation of anemia Hemoglobin and/or hematocrit Red blood cell indices Reticulocyte count Occult blood in stool Serum iron TIBC Transferrin saturation Serum ferritin Percen. of hypochromic red cells Iron parameters NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES CRP TSN ANEMIA GUIDELINES

11 Evaluation of anemia Serum vitamin B 12 and folic acid Differential white blood count Tests for hemolysis Serum protein electroforesis Bone marrow examination Serum aluminium A fuller work-up should also include the following, as indicated Hemoglobin electroforesis TSN ANEMIA GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES PRACTICE GUIDELINES

12 No cause for anemia is detected by the work-up Erythropoietin deficiency Anemia is most likely due to EPO deficiency If A normocytic, normochromic anemia is present Impairment of renal function is present NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES

13 Indications for starting treatment with Erythropoietin EPO treatment should be considered EPO treatment should be considered  when the Hb concentration is consistently less than 11 g/dl on repeating testing (Hct <33%) 11 g/dl on repeating testing (Hct <33%)  when other causes of anemia have been excluded NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES

14 Indications for starting treatment with Erythropoietin TSN ANEMIA GUIDELINES Hb <10 g/dl Htc <30% EPO TREATMENT Higher Hb and/or Hct levels ASYMPTOMATICPATIENTS SYMPTOMATICPATIENTS Heart failure, angina

15 Serum creatinine  2 mg/dl Check Hb Work-up Normal Fe deficiency Treat with EPO if indicated Anemia not corrected <12 g/dl in males and post-menopausal females <11 g/dl in pre-menopausal females and pre-pubertal patients Treat with iron Anemia corrected Hematologywork-up No

16 Target hematocrit/hemoglobin for erythropoietin therapy Hemoglobin Hematocrit g/dl 33-36% NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES Variations in the target Hb may be required in patients with co-morbidity

17 Assesment of iron status Serum iron Total iron binding capacity Transferrin saturation Serum ferritin Percentage of hypochromic red cells Iron stores in bone marrow RBC ferritin concentration NKF-DOQI GUIDELINES TSN ANEMIA GUIDELINES BEST PRACTICE GUIDELINES

18 Target iron level Transferrin saturation Serum ferritin >20% >100 ng/ml 30-40% ng/ml The patients should have sufficient iron to achieve and maintain an Hb (Hct) of g/dl (33-36%) Hypochromic red cells <10% <2.5% (<5%) OPTIMAL TSN ANEMIA GUIDELINES NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES

19 Monitoring iron status Every month Every 3 months Every 3-6 months Patients treated with Epo Patients not treated with Epo Hb/Hct stable Ferritin  100 ng/ml TSAT  20% Hb <11 g/dl Hct <33% Hb g/dl Hct 33-36% Every 3 months NKF-DOQI GUIDELINES BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES Receiving IV iron Not receiving IV iron

20 Administration of supplemental iron TSAT <20% Ferritin <100 ng/ml mg IV iron at every HD seans for 8-10 doses mg IV iron per week mg IV iron at every HD seans for 8-10 doses TSAT <20% Ferritin <100 ng/ml TSAT >20% Ferritin >100 ng/ml IV iron therapy should be withheld for 3 months TSAT >50% Ferritin >800 ng/ml

21 Oral iron therapy It should be given as 200 mg of elemental iron per day, in two to three divided doses in the adult patient, and 2-3 mg/kg/day in the pediatric patient When oral iron is used NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES

22 Route of administration of erythropoietin EPO should be administered SC in PD patients The most effective route of EPO is SC in HD patients INTRAVENOUS SUBCUTANEOUS INTRAPERITONEAL INTRADERMAL NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES

23 Initial erythropoietin administration SC units/kg/week, in two to three doses per week IV units/kg/week, in three doses per week NKF-DOQI GUIDELINES

24 Initial erythropoietin administration SC The starting dose should be in the lower range IV The starting dose should be in the upper range EUROPEAN BEST PRACTICE GUIDELINES The starting dose of EPO should be units/kg/week

25 Initial erythropoietin administration SC The starting dose should be 75 units/kg/week IV The starting dose should be 150 units/kg/week TSN ANEMIA GUIDELINES

26 Monitoring of Hb/Hct during erythropoietin therapy Every 1-2 weeks Every 2-4 weeks Target Hb/Hct is achieved Target Hb/Hct is not achieved NKF-DOQI GUIDELINES BEST PRACTICE GUIDELINES Every 1-2 weeks TSN ANEMIA GUIDELINES Every 2 weeks NKF-DOQI GUIDELINES BEST PRACTICE GUIDELINES TSN ANEMIA GUIDELINES Every 4-6 weeks Every 4 weeks

27 Titration of erythropoietin dosage Dose should be increased by 50% Dose should be decreased by 25-50% After initation of EPO After a dose increase If the increase in Hb (Hct) is <0.7 g/dl (<2%) over a 2-4 week period If the increase in Hb/Hct is >2.5 g/dl (>8%) per month NKF-DOQI GUIDELINES BEST PRACTICE GUIDELINES If the Hb (Hct) exceeds the target levels

28 Titration of erythropoietin dosage Dose should be increased by units/kg/week Dose should be decreased by 50% After initation of EPO After a dose increase If the increase in Hb (Hct) is <1.0 g/dl (<3%) over a 4-6 week period TSN ANEMIA GUIDELINES If the increase in Hb/Hct is >1.5 g/dl (>5%) per month

29 Inadequate response to erythropoietin Failure to achieve target Hb/Hct in the presence of adequate iron stores at dose of 450 units/kg/wk IV or 300 units/kg/wk SC within 4-6 months or failure to maintain target Hb/Hct subsequently at that dose DEFINITION Failure to attain the target Hb concentration while receiving more than 300 units/kg/wk (~ units/wk) of EPO SC or a continued need for such dosage to maintain the target NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES

30 Inadequate response to erythropoietin DEFINITION TSN ANEMIA GUIDELINES Despite the EPO therapy at dose of 300 units/kg/week, no increase in Hb more than 2 g/dl within 12 weeks

31 Causes of inadequate response to erythropoietin Iron deficiency Infection/inflamation Chronic blood loss Osteitis fibrosa Aluminium overload Folate/Vitamin B 12 deficiency HemoglobinopathiesMalnutrition Hemolysis Multiple myeloma NKF-DOQI GUIDELINES EUROPEAN BEST PRACTICE GUIDELINES

32 EPO RESISTANCE Non-compliance Iron stores Adequate CRP ReticulocyteLDHBilirubin Blood smear Occult blood in stool Vitamin B 12 /Folate Blood smear PTH Bone marrow examination Serum aluminium Hb electrof. Inadequate InfectionInflammationMalignancy Blood loss Hemolysis Vitamindeficiency Aluminiumoverload Bone marrow fibrosis Hemoglobinopathies TSN ANEMIA GUIDELINES

33 LEGAL ARRANGEMENTS

34 Ministry of Finance 2003 Fiscal Year Budget Application Directions Official Gazette: Date , Number Use of erythropoietin in patients with chronic renal failure The target Hct level for EPO therapy is 30-35% If the target Hct is achieved, EPO dose should be decreased If the Hct level exceeds 40%, EPO therapy should be interrupted until Hct is decreased to target level EPO should be administered subcutaneously If failure to achieve the target Hct within 3 months, EPO therapy should be interrupted and causes of resistance should be examined

35 Social Insurance Institution (SSK) 2002 Year Drug Application Directions EPO therapy should be used when the Hb (Hct) is less than 8 g/dl (24%) If the following conditions is determined during the initial evaluation, EPO therapy should not be used Iron deficiency Blood loss Hemolysis Chronic infection Aluminium overload Hyperparathyroidism Uncontrolled hypertension Vascular access thrombosis Ischemic vascular disease Item 30Principles of erythropoietin usage

36 Social Insurance Institution (SSK) 2002 Year Drug Application Directions EPO Resistance: Despite the EPO therapy at dose of 150 units/kg/week, no increase in Hb/Hct within 3 months The target Hb (Hct) level is g/dl (30-33%) If the Hb (Hct) level exceeds the 11 g/dl (33%), EPO therapy should be interrupted If no increase in Hb/Hct level within two months, EPO therapy should be interrupted EPO should be administered subcutaneously

37 CURRENT ASPECTS OF ANEMIA THERAPY AND USE OF ERYTHROPOIETIN IN TURKEY

38 Use of erythropoietin in dialysis patients in Turkey % TSN Registry

39 Use of erythropoietin in hemodialysis patients in Turkey % Ministry of Health Data

40 Mean hemoglobin level in dialysis patients in Turkey TSN Registry-2002

41 Percent of patients with hemoglobin  11 g/dl in Turkey % TSN Registry

42 The success rate with erythropoietin in dialysis patients in Turkey % TSN Registry-2002

43 Use of iron therapy in dialysis patients in Turkey % TSN Registry-2002

44 Serum ferritin level in dialysis patients in Turkey % TSN Registry-2002

45 Data of United Kingdom Renal Registry %

46 CONCLUSION Today, anemia treatment and use of erythropoietin is guided by social security organisations in Turkey Anemia is present in the majority of the patients with CRF, and when untreated, it is associated with poor clinical outcomes Directions of erythropoietin usage suggested by these organisations are cost-based but not evidence-based Principles of anemia treatment in Turkey should be rearranged according to TSN Anemia Guidelines


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