OUR LADY OF LOURDES MEDICAL CENTER

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OUR LADY OF LOURDES MEDICAL CENTER
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JOHN P. CAPELLI, MD DIRECTOR, DIALYSIS AND
TRANSPLANT SERVICES SENIOR VP MEDICAL
AFFAIRS CONFLICT OF INTEREST STATEMENT NO
DIRECT FINANCIAL SUPPORT FROM AMGEN NO CONSULTING
OR CONTRACTUAL RELATIONSHIP INVESTIGATOR IN
EVOLVE STUDY MERRILL LYNCH PORTFOLIO STOCK
HARVEY KUSHNER, PhD President, BioMedical
Computer Research Institute CONFLICT OF INTEREST
STATEMENT NO CONFLICTS TO REPORT
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IMPACT OF FDA ESA WARNING ON RENAL PATIENTS

• Insurance Companies Have Made Payment For ESAs
  Difficult Because Of the Cost, Now Have Stronger
  Basis To Deny Payment To Any Patient With HG In
  Excess Of 12 gm/dL
• Nephrologists Are Uncertain with Regard To
  Established Protocols For Dosing
• Nephrologists Are Now Fearful of Malpractice
  Suits Should Patient Exceed 12 gm/dL And Have An
  Adverse Cardiac Event
• Resultant Effect Will Be To Reduce Doses Promptly
  And Under Dose In Effort To Stay with the Narrow
  Range Of 11- 12 gm/dL
• Patients Are More Likely To Have Average HG Under
  11 gm/dL Potentially Leading to Shortened
  Survival, More ACE, And Hospitalizations

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Variability in Hgb How fast can it change? -
radically in short periods of time
USRDS Annual Report, 2006
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CREATE AND CHOIR STUDIES

• Both are Open-Label RCTs In Non-Dialyzed CKD
  Patients
• Both Tested Hypothesis That Higher Hemoglobin
  Levels Would Lead To Improved Patient Outcomes
• Both Reported Negative Results As it Related To
  Improved Outcomes
• CREATE Study Did Not Describe Harm To Patients
  Randomized To The Higher Hemoglobin Group
• CHOIR Study Was Discontinued After Interim
  Analysis Because No Benefit Could Be Determined,
  And There Was Evidence Of Increased Risk
• Cancer Studies Report Results Indicating
  Increased Risk Of Death, Deep Vein Thromboses,
  ACE

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CLINICAL STUDY REPORT PR00-06-014 (CHOIR)

• Primary Outcome
• Group A (High HG) Was 1.337 Times AS Likely To
  Experience Composite Event As A Patient In Group
  B (Low HG)
• 65 (29.3) Deaths, 39 (31.2) In Group A And 26
  (26.8) In Group B
• 101 (45.5) CHF Hospitalizations, 59 (47.2) In
  Group A And 42 (43.3) In Group B
• 25 (11.3 ) Non-Fatal MIs, 12 (9.6) In Group A
  And 13 (13.4) in Group B
• 23 (10.4) Non-Fatal Strokes, 12 (9.6) In Group
  A And 11 (11.4) In Group B
• 0 Event of Stroke And Death In Group A And 1 (1)
  In Group B
• 7 (3.2) Events Of CHF Hospitalization And
  Non-Fatal MI, 3 (2.4) In Group A And 4(4.1) In
  Group B

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ISSUES RAISED WITH CURRENT STUDIES

• CHOIR Study Reported Half Of Patients Dropped
  Out, Making Suspect Any Conclusions Drawn From
  Analyses Performed On Remaining Patients
• Authors Admit Presence of Imbalance In The
  Original Cohort With Regard To CABG And HTN
• Admit That The Failure To Adjust For These
  Characteristics Could Have Impacted On ACE

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CLINICAL STUDY REPORT PR00-06-014 (CHOIR)

• Commentary From Report
• The Results Of The Multivariant Analyses
  Suggested That Pre-existing Medical
• Conditions of CHF, NHANES CHF Score gt3, and
  Atrial Fibrillation/Flutter, Baseline
• Laboratory Values Of Lower Serum Albumin And
  Higher Percent Reticulocyte Count,
• And Older Age Were Significantly Associated With
  The Occurrence Of Composite
• Events. When These Baseline Variables Were
  Included In The Multivariant Analyses,
• The Association Between Randomization Group And
  Composite Event WAS NO
• LONGER STATISTICALLY SIGNIFICANT. However, a
  trend toward a Higher Risk
• Of Events In Group A Remained (Hazard Ratio
  1.243 95CI 0.951 to 1.624, p0.111).
• These Data Suggest That Baseline Patient Factors
  Are Important In Predicting
• Composite Events

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• IMPACT OF HEMOGLOBIN LEVELS ON
• OUTCOMES IN HEMODIALYSIS
• PATIENTS
• OUR LADY OF LOURDES MEDICAL CENTER
• In Comparison To
• USRDS Data System, NIDDK, 2006
• N95,000 HD patients in 2004

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2006 CMS DIALYSIS FACILITY REPORTStandardized
Mortality Ratio (SMR) OUR LADY OF LOURDES - CM
US
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2006 CMS DIALYSIS FACILITY REPORTStandardized
Mortality Ratio (SMR) OUR LADY OF LOURDES - ML
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ESRD DEATH RATES
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All Facilities Network 3Standardized
Mortality Ratio Trends 2001-2004
OLL ML OLL - CM
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ANEMIA MANAGEMENT TARGETS

• CMS/ESRD NETWORK TARGET
• 80 Of Patient Caseload At HG Of 11 gm/dL Or HCT
  Of 33
• Recognizes Target Range Of 11 12 gm/dL, But
  Continues Reimbursement Even If HG/HCT Exceeds
  Target Range As Long As 3-Month Rolling Average
  is lt12.5 gm/dL
• Recognition Of Biologic Variability
• K/DOQI GUIDELINES
• Target Range For HG (HCT) Should Be 11 gm/dL
  (33) To 12 gm/dL (36)
• No Prohibition Against Higher Levels Given Amount
  Favorable Data
• OUR LADY OF LOURDES POLICY
• Hemodialysis Target Range 11 12 gm/dL
• Decrease Dose By 10 When HG Is 12.1 13.0 gm/dL
• Decrease Dose By 15 When HG Is 13.1 14.5 gm.dL
• Decrease Dose By 25 When HG Is gt 14.6 gm/dL

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Anemia Management 1999 - 2006
Annual Caseload Hemoglobin Levels
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2006 CMS DIALYSIS FACILITY REPORT SEPTICEMIA OUR
LADY OF LOURDES - CM
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2006 CMS DIALYSIS FACILITY REPORT SEPTICEMIA OUR
LADY OF LOURDES - ML
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COMPARISON OF FACILITY SMR
IMPACT OF OUTCOMES ON STANDARDIZED MORTALITY RATES

COMPARISON OF FACILITY AT TARGET HG
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AVERAGE SINGLE EPOGEN DOSE/PATIENT
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MEAN MONTHLY HG AND MEAN EPO DOSE PER WEEK
USRDS Annual report, 2006
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DEMOGRAPHIC CHARACTERISTICSSTUDY GROUP 2003 -
2006

• Patients (n) 824
• Sex ()
• Male 56
• Female 44
• Avr Age
• Q1 2003 59
• Q16 2006 64
• Race ()
• Black 41
• Cauc 46
• Hispanic 10
• Other 3
• Hospitalization() 22.3
• Infection () 3.9
• Total Days/Qrtr 2.5
• Death Rate 200/- 36
• Q12-Q16 172/- 6
• Q1 Q11 210/- 36
• National Average 237

Death Rate Deaths per 1000 patient years
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17
49
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Hg gt11.0 lt13.3 and Albumin gt3.5 lt4..0
Hg gt11.0 lt13.3 and Albumin gt4..0
Hg gt13..3 and Albumin gt4..0
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DEATH RATES/1000 PATIENT YEARS BY GROUPS

• VARIABLE DEATH
  RATE
• ALBUMIN (gm/dL)
• Alb lt 3.5 764 384
• 3.5 Alb lt4.0 142 75
• 4.0 Alb
  35 38
• HEMOGLOBIN (gm/dL)
• Hgb lt 11.0 589 234
• 11.0 Hgb 13.3 181 63
• 13.3 lt Hgb
  68 37
• ALBUMIN HEMOGLOBIN (gm/dL)
• Alb lt3.5 Hgb lt 11.0 1116
  418
• Alb lt 3.5 11.0 Hgb 13.3
  296 112
• 4.0 Alb or 13.3 lt Hgb 117 90
• 4.0 Alb 13.3 lt Hgb
  18 29

Mean rates over all 16 quarters
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ADJUSTED MORTALITY RATES BY VINTAGE
USRDS Annual Report 2006
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INDEPENDENT VARIABLESAVAILABLE TO THE MODEL

• Age Cholesterol
• Sex Hemoglobin
• Race Hematocrit
• Years In Dialysis Ferritin
• Albumin Transferrin Sat
• Calcium Hospitalization
• Phosphorus Total Hosp Days
• CaP Product Infections
• Intact PTH

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MODELING MORTALITY OUTCOMES
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FINAL OBSERVATIONS

• MAJOR FACTORS ASSOCIATED WITH SURVIVAL
• Maximum Levels Of Hemoglobin
• Maximum Levels Of Albumin
• Minimum Levels Of CalciumPhosphorus Product
• Years of Dialysis
• Overall Death Rate Is Significantly Better Than
  National Statistics
• 200 vs 237 Death Rate/1000 Patient Year
• Dramatic Reduction In Death Rates For Patients On
  Dialysis gt 3 Years
• In 2005 And 2006, Death Rate/1000 Patient Years
  Is The Same For Dialysis Treatment lt3 Years Or gt
  3 Years
• Outcomes Significantly Better Than National
  Averages

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Further Work

• Awaiting the USRDS CPM Data Set
• Analytic comparison of our data with USRDS data
• Refinement of statistical models