CONTENTS American Journal of Kidney Diseases - National Kidney PDF
Preview CONTENTS American Journal of Kidney Diseases - National Kidney
AJKD VOL47,NO5,SUPPL3,MAY2006 CONTENTS AmericanJournalof KidneyDiseases KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease Tables............................................................................................................................... S1 Figures............................................................................................................................. S2 AbbreviationsandAcronyms........................................................................................ S4 WorkGroupMembership............................................................................................... S7 KDOQIAdvisoryBoardMembers.................................................................................. S8 Foreword.......................................................................................................................... S9 I. EXECUTIVESUMMARY S11 II. CLINICALPRACTICEGUIDELINESANDCLINICALPRACTICERECOMMEN- DATIONSFORANEMIAINCHRONICKIDNEYDISEASEINADULTS S16 1.1.IdentifyingPatientsandInitiatingEvaluation.................................................... S17 1.2.EvaluationofAnemiainCKD............................................................................. S28 2.1.HbRange............................................................................................................ S33 3.1.UsingESAs......................................................................................................... S54 3.2.UsingIronAgents............................................................................................... S58 3.3.UsingPharmacologicalandNonpharmacologicalAdjuvantstoESATreatment inHD-CKD......................................................................................................... S71 3.4.TransfusionTherapy.......................................................................................... S79 3.5.EvaluatingandCorrectingPersistentFailureToReachorMaintainIntended Hb....................................................................................................................... S81 III. CLINICALPRACTICERECOMMENDATIONSFORANEMIAINCHRONICKID- NEYDISEASEINCHILDREN S86 1.1:IdentifyingPatientsandInitiatingEvaluation.................................................... S87 1.2:EvaluationofAnemiainCKD............................................................................. S89 2.1:HbRange............................................................................................................ S90 3.1:UsingESAs......................................................................................................... S93 3.2:UsingIronAgents............................................................................................... S99 3.3:UsingPharmacologicalandNonPharmacologicalAdjuvantstoESATreatment inHD-CKD......................................................................................................... S105 3.4:TransfusionTherapy.......................................................................................... S106 3.5:EvaluatingandCorrectingPersistentFailureToReachorMaintainIntended HbLevel............................................................................................................. S107 IV.CLINICALPRACTICERECOMMENDATIONSFORANEMIAINCHRONICKID- NEYDISEASEINTRANSPLANTRECIPIENTS S109 V.APPENDIX1:METHODSOFEVIDENCEREVIEWANDSYNTHESIS................... S117 WorkGroupBiographies............................................................................................. S126 Acknowledgments....................................................................................................... S131 References.................................................................................................................... S132 KDOQI Disclaimer SECTION I: USE OF THE CLINICAL PRACTICE GUIDELINES AND CLINICAL PRACTICE RECOMMENDATIONS These Clinical Practice Guidelines (CPGs) and Clinical Practice Recommendations (CPRs) are based upon the best information available at the time of publication. They are designed to provide information and assist decision-making. They are not intended to define a standard of care, and shouldnotbeconstruedasone.Neithershouldtheybeinterpretedasprescribinganexclusivecourse ofmanagement. Variationsinpracticewillinevitablyandappropriatelyoccurwhenclinicianstakeintoaccountthe needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every health-care professional making use of these CPGs and CPRs is responsible for evaluatingtheappropriatenessofapplyingtheminthesettingofanyparticularclinicalsituation.The recommendationsforresearchcontainedwithinthisdocumentaregeneralanddonotimplyaspecific protocol. SECTIONII:DEVELOPMENTPROCESS The National Kidney Foundation makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional or business interestofamemberoftheWorkGroup. Specifically, all members of the Work Group are required to complete, submit and sign a DisclosureQuestionnaireshowingallsuchrelationshipsthatmightbeperceivedasrealorpotential conflictsofinterest.Allaffiliationsarepublishedintheirentiretyattheendofthispublicationinthe BiographicalSketchsectionoftheWorkGroupmembers. Incitingthisdocument,thefollowingformatshouldbeused:NationalKidneyFoundation.KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease.AmJKidneyDis47:S1-S146,2006(suppl3). SupportforthedevelopmentoftheKDOQIClinicalPracticeGuidelinesandClinicalPractice RecommendationsforAnemiainChronicKidneyDiseasewasprovidedbyAmgen,Inc. The National Kidney Foundation gratefully acknowledges the support ofAmgen, Inc. as the foundingandprincipalsponsorofKDOQI. Tables Table1. KeyDifferencesBetweenCurrentGuidelines(KDOQIAnemia2006)and PreviousAnemiaGuidelines(KDOQI2000andEBPG2004)......................................S15 Table2. RelationshipBetweenHbLevelandKidneyFunction .................................................S18 Table3. RelationshipBetweenHctandKidneyFunction............................................................S19 Table4. PrevalenceofAnemiabyLevelofKidneyFunction......................................................S20 Table5. DifferenceinHbandHctFromReferencebyCategoryofC ......................................S20 Cr Table6. DifferenceinHbandHctFromReferenceAccordingtoCategoryofBSA andNormalizedeGFR...........................................................................................S21 Table7. HbforMalesbyRace/EthnicityandAge:UnitedStates,1988to1994.........................S24 Table8. HbforFemalesbyRace/EthnicityandAge:UnitedStates,1988to1994.....................S25 Table9. NormalIncreaseinHbLevelsRelatedtoLong-TermAltitudeExposure......................S26 Table10. MaximumHbCutoffValuesforAnemiainPregnancy..................................................S27 Table11. AdjustmenttoHbforSmokingbyNumberofPacketsperDay.....................................S27 Table12. RCTsExaminingEffectsofDistinctHbTargets/LevelsonKeyClinicalOutcomes intheHD-CKDandPD-CKDPopulations....................................................................S34 Table13. RCTsExaminingEffectsofDistinctHbTargets/LevelsonQOLintheHD-CKD andPD-CKDPopulations...............................................................................................S36 Table14. Non-CVD/MortalityAERatesinRCTsExaminingDistinctHbTargets/Levels inHD-CKDandPD-CKDPopulations:ESAversusESA.............................................S38 Table15. Non-CVD/MortalityAERatesinRCTsExaminingDistinctHbTargets/Levels intheHD-CKDandPD-CKDPopulations:ESAversusPlacebo..................................S40 Table16. EffectsofDistinctHbTargets/LevelsonKeyClinicalOutcomesinthe ND-CKDPopulation......................................................................................................S41 Table17. RCTsExaminingEffectsofDistinctHbTargets/LevelsonQOLinthe ND-CKDPopulation......................................................................................................S42 Table18. Non-CVD/MortalityAERatesinRCTsExaminingDistinctHbTargets/Levels intheCKDPopulation..........................................................................................S43 Table19. RCTsExaminingEffectsofDistinctHbTargets/LevelsonExerciseCapacity intheHD-CKDandPD-CKDPopulations....................................................................S44 Table20. TargetHbLevelsintheHD-CKDandPD-CKDPopulations........................................S45 Table21. TargetHbLevelsintheND-CKDPopulation................................................................S48 Table22. AnemiaManagementProtocolInformationforInitialAnemiaManagement UsedinESARCTs................................................................................................S56 Table23. RCTsforFerritinandTSATTargetsintheHD-CKDPopulation..................................S60 Table24. ValueofBaselineFerritinforAssessingLikelihoodofResponsetoIVIronTherapy intheHD-CKDPopulation............................................................................................S61 Table25. ValueofFerritininAssessingIronStorageExcessorDeficiency..................................S61 Table26. ValueofBaselineTSATforAssessingLikelihoodofResponsetoIVIronTherapy intheHD-CKDPopulation............................................................................................S62 Table27. ValueofBaselineCHrforAssessingLikelihoodofResponsetoIVIronTherapy........S62 Table28. MeanMonthlyDoseofIroninAdultPrevalentHD-CKDPatientsonESATherapy....S63 Table29A. ComparativeRCTsofIVversusPOIronAdministrationandEfficacyof AnemiaManagementintheHD-CKDandPD-CKDPopulations.................................S65 Table29B. ComparativeRCTsofIVversusPOIronAdministrationandEfficacyof AnemiaManagementintheND-CKDPopulation.........................................................S65 Table30. ComparativeRCTsofPOIronAdministrationversusPlacebo/Controland EfficacyofAnemiaManagementintheHD-CKDandPD-CKDPopulations ....................S66 Table31. SeriousAEsofIronAgentsinPatientsNaïvetoTestedIronAgent(N(cid:1)100).............S66 Table31A. IVversusPOIronAgentsintheHD-CKDandPD-CKDPopulations..........................S67 AmericanJournalofKidneyDiseases,Vol47,No5,Suppl3(May),2006:ppS1-S3 S1 S2 FIGURES Table31B. IVversusPOIronAgentsintheND-CKDPopulation ..................................................S67 Table32. RCTsEvaluatingEffectsofTreatmentwithIVL-CarnitineonHbLevelsandESA DosesintheHD-CKDPopulation..................................................................................S72 Table33. UseofL-CarnitineasanAdjuvanttoESATreatmentintheHD-CKDPopulation..............S73 Table34. RCTsEvaluatingEffectsofTreatmentWithIVAscorbicAcidonHbLevels andESADosesintheHD-CKDPopulation...........................................................................S74 Table35. UseofAscorbicAcidasanAdjuvanttoESATreatmentsintheHD-CKDPopulation........S74 Table36. RCTsEvaluatingEffectsofTreatmentWithIMAndrogensonHbLevelsinthe HD-CKDPopulation......................................................................................................S75 Table37. UseofAndrogensasanAdjuvanttoESATreatmentintheHD-CKDPopulation.........S76 Table38. PublishedExperienceinPatientsWithAnemia,CKD,andaPreexisting HematologicDisorder....................................................................................................S84 Table39. HbLevels(g/dL)inChildrenBetween1and19YearsforInitiationof AnemiaWorkup..............................................................................................................S88 Table40. HbLevels(g/dL)inChildrenBetweenBirthand24MonthsforInitiation ofAnemiaWorkup..........................................................................................................S88 Table41. LiteratureReviewofAnemiainTransplantCKD:KeyConclusions...........................S110 Table42. PrevalanceofPTAbyDurationofPosttransplantationPeriod.....................................S112 Table43. ExampleofaSummaryTable.......................................................................................S119 Table44. SystematicReviewTopicsandScreeningCriteria.......................................................S120 Table45. LiteratureSearchYieldofPrimaryArticlesforSystematicReviewTopics.................S121 Table45A. AssessmentofStudyApplicability...............................................................................S121 Table46. DetailsofFirst-LookTopics,OvidLiteratureSearches,andYieldbyTopic...............S122 Table46A. GradesforStudyQuality..............................................................................................S122 Table47. EvaluationofStudiesofPrevalence.............................................................................S123 Table48. FormatforGuidelines...................................................................................................S123 Table49. BalanceofBenefitandHarm.................................................................................................S124 Table50. DefinitionsofGradesforQualityofOverallEvidence................................................S124 Table51. ExampleofanEvidenceProfile...................................................................................S125 Figures Figure1. KidneyFailureintheUnitedStates.................................................................................S12 Figure2. RelationshipBetweenCurrentandPreviousAnemiaGuidelines....................................S14 Figure3. RelationshipBetweenHbLevelandeGFR.....................................................................S21 Figure4. RelationshipBetweeneGFRandPrevalenceofAnemiaasDefinedbyDifferingHb Levelsfor(A)Malesand(B)Females.............................................................................S21 Figure5. PrevalenceofAnemiabyCKDStage..............................................................................S22 Figure6. RelationshipBetweenLevelofRenalFunction,ReflectedbyS Levelor Cr GFR,andPrevalenceofAnemia,DefinedatDifferentHbCutoffLevels,Among PatientsundertheCareofPhysicians..............................................................................S22 Figure7. HbPercentilesbyGFRintheCanadianMulticentreLongitudinalCohortStudy...........S22 Figure8. PrevalenceofLowHbLevelbyCategoryofGFRintheCanadianMulticentre LongitudinalCohortStudy...............................................................................................S23 Figure9. PrevalenceofLowHbLevelbyeGFRinPatientswithDiabeticsComparedwiththe GeneralPopulation.....................................................................................................................S23 Figure10. ChangesinHbLevelsandeGFROver2yearsinAdultPatientswithCKDStages3 and4NotTreatedwithESA............................................................................................S23 Figure11. DistributionofHbLevelsinAdultMalesandFemalesbyAgeGroup............................S26 Figure12. DistributionofFerritinandTSATValuesbyAgeGroupinMalesandFemales.............S30 FIGURES S3 Figure13. DistributionofHbLevelsbyFerritinRangeinPatientswithCKD................................S31 Figure14. DistributionofHbLevelsbyTSATRangeinPatientswithCKD...................................S31 Figure15. TargetandAchievedHbLevelsin18RCTsComparingHigherAgainstLower (orPlacebo/Control)HbTargetsforESATherapy..........................................................S50 Figure16. BaselineMeanPretreatmentHbLevelsComparedwithAchievedMeanHb LevelsintheUpperandLowerTarget.....................................................................S51 Figure17. ExposuretoEprex®andCaseCountsofPRCA..............................................................S82 Figure18. MeanEpoetinDoseperPatientperAdministrationbyPercentileofDose(1st,5thto 95th,and99th).................................................................................................................S82 Figure19. ProcessofTriagingaTopictoaSystematicRevieworaNarrativeReview........................S118 Acronyms andAbbreviations (cid:1) Change 1 Increase 2 Decrease ABP Ambulatorybloodpressure ABPM Ambulatorybloodpressuremonitoring ACE Angiotensin-convertingenzyme ADE Adversedrugevent AE Adverseevent ARBs Angiotensinreceptorblockers ARF Acuterenalfailure AST Aspartatetransaminase BID Twicedaily BIW Twiceweekly BP Bloodpressure BSA Bodysurfacearea CABG Coronaryarterybypassgraft CBC Completebloodcount C Creatinineclearance Cr CESDS CenterforEpidemiologicStudiesDepressionScale CFU-E Erythroidcolony-formingunits CHF Congestiveheartfailure CHOIR CorrectionofHemoglobinandOutcomesinRenalInsufficiency CHr Contentofhemoglobininreticulocytes CI Confidenceinterval CKD Chronickidneydisease CMV Cytomegalovirus CPG Clinicalpracticeguideline CPR Clinicalpracticerecommendation CREATE CardiovascularRiskReductionbyEarlyAnemiaTreatmentWithEpoetinBetaTrial CRI Correctedreticulocyteindex CV Cardiovascular CVA Cerebrovascularaccident CVD Cardiovasculardisease D/C Discontinuation DBP Diastolicbloodpressure DNA Deoxyribonucleicacid DOQI DialysisOutcomesQualityInitiative EBPG EuropeanBestPracticesGuideline eGFR Estimatedglomerularfiltrationrate ERI Erythropoietinresistanceindex ERT EvidenceReviewTeam ESA Erythropoiesis-stimulatingagent ESRD End-stagerenaldisease FACIT FunctionalAssessmentofChronicIllnessTherapy FDA FoodandDrugAdministration GFR Glomerularfiltrationrate GI Gastrointestinal Hb Hemoglobin Hct Hematocrit HD Hemodialysis S4 AmericanJournalofKidneyDiseases,Vol47,No5,Suppl3(May),2006:ppS4-S6 ACRONYMSANDABBREVIATIONS S5 HD-CKD Hemodialysis-dependentchronickidneydisease HDF Hemodiafiltration HPS Hemophagocyticsyndrome HTN Hypertension HU Hydroxyurea HUI HealthUtilitiesIndex HUS Hemolyticuremicsyndrome IHD Ischemicheartdisease IM Intramuscular IU InternationalUnit IV Intravenous KDIGO KidneyDisease:ImprovingGlobalOutcomes KDOQI KidneyDiseaseOutcomesQualityInitiative KDQ KidneyDiseaseQuestionnaire KDQOL KidneyDiseaseQualityofLife KEEP KidneyEarlyEvaluationProgram KLS KidneyLearningSystem KPS KarnofskyPerformanceScale LV Leftventricular LVD Leftventriculardilation LVEDd Leftventricularend-diastolicdiameter LVH Leftventricularhypertrophy LVMI Leftventricularmassindex LVVI Leftventricularvolumeindex MAP Meanarterialbloodpressure MCH Meancorpuscularhemoglobin MCHC Meancorpuscularhemoglobinconcentration MCV Meancorpuscularvolume MDRD4 ModificationofDietinRenalDisease MI Myocardialinfarction MR Mitralregurgitation N,n Numberofsubjects N/A Notapplicable NAPRTCS NorthAmericanPediatricRenalTransplantCooperativeStudy nd Notdocumented ND-CKD Non–dialysis-dependentchronickidneydisease NHANES NationalHealthandNutritionandExaminationSurvey NKF NationalKidneyFoundation NOS Nototherwisespecified NS Notsignificant OR Oddsratio PD Peritonealdialysis PD-CKD Peritonealdialysis–dependentchronickidneydisease PHRBC Percenthypochromicredbloodcells PHRC Percenthypochromicredcells PO Oral PRCA Pureredcellaplasia Pt Patient PTA Posttransplantationanemia QoAL QualityofAmericanLife QOL Qualityoflife S6 ACRONYMSANDABBREVIATIONS QOW Everyotherweek RCT Randomizedcontrolledtrial rHuEPO Recombinanthumanerythropoietin RQoLP RenalQualityofLifeProfile RR Relativerisk SAE Severeadverseevent SBP Systolicbloodpressure SC Subcutaneous SCD Suddencardiacdeath S Serumcreatinine Cr SF-36 36-ItemMedicalOutcomesStudyShort-FormHealthSurvey SIP SicknessImpactProfile SQUID Superconductingquantuminterferencedevice TDS Totaldailysupplement TID Thricedaily TIW Thriceweekly TRESAM TransplantEuropeanSurveyonAnemiaManagement TSAT Transferrinsaturation TTO Timetrade-off TTP Thromboticthrombocytopenicpurpura Tx-ND-CKD Non–dialysis-dependentkidneytransplantrecipientpopulation U Unit URR Ureareductionratio USFDA UnitedStatesFoodandDrugAdministration USRDS UnitedStatesRenalDataSystem vs Versus WHO WorldHealthOrganization ZPP Zincprotoporphyrin Anemia in Chronic Kidney Disease Work Group Membership WorkGroupCo-Chairs DavidB.VanWyck,MD Kai-UweEckardt,MD UniversityofArizonaCollegeofMedicine UniversityofErlangen-Nuremberg Tucson,AZ Erlangen,Germany WorkGroup JohnW.Adamson,MD PatriciaBargoMcCarley,RN,MSN,NP BloodCenterofSEWisconsin DiabloNephrologyMedicalGroup BloodResearchInstitute WalnutCreek,CA Milwaukee,WI HansH.Messner,MD GeorgeR.Bailie,MSc,PharmD,PhD UniversityHealthNetwork AlbanyCollegeofPharmacy PrincessMargaretHospital Albany,NY Toronto,Canada JeffreyS.Berns,MD AllenR.Nissenson,MD UniversityofPennsylvaniaSchoolofMedicine UCLAMedicalCenter Philadelphia,PA LosAngeles,CA StevenFishbane,MD GregorioT.Obrador,MD WinthropUniversityHospital UniversidadPanamericanaSchoolofMedicine Mineola,NY MexicoCity,Mexico RobertN.Foley,MD JohnC.Stivelman,MD NephrologyAnalyticalServices NorthwestKidneyCenter Minneapolis,MN Seattle,WA SanaGhaddar,RD,PhD ColinT.White,MD AmericanUniversityofBeirut BritishColumbiaChildren’sHospital FacultyofAgricultureandFoodSciences Beirut,Lebanon Vancouver,Canada JohnS.Gill,MD,MS LiaisonMember UniversityOfBritishColumbia FrancescoLocatelli,MD St.Paul’sHospital AziendaOspedalieraDILecco Vancouver,Canada Lecco,Italy KathyJabs,MD IainC.Macdougall,MD VanderbiltUniversityMedicalCenter King’sCollegeHospital Nashville,TN London,England EvidenceReviewTeam NationalKidneyFoundationCenterforGuidelineDevelopmentandImplementationatTufts-NewEngland MedicalCenter,Boston,MA KatrinUhlig,MD,MS,ProjectDirectorandProgramDirector,Nephrology ChristinaKwackYuhan,MD,AssistantProjectDirector AmyEarley,BS AshishMahajan,MD,MPH RebeccaPersson,BA PriscillaChew,MPH GowriRaman,MD Inaddition,supportandsupervisionwasprovidedby: JosephLau,MD,ProgramDirector,EvidenceBasedMedicine EthanBalk,MD,MPH,EvidenceReviewTeamCo-Director AndrewS.Levey,MD,CenterDirector
Description:The list of books you might like
