prevention and treatment of chronic kidney disease: early
TRANSCRIPT
Prevention and Treatment of Chronic Kidney Disease: Early
Diagnosis and Aggressive Treatment are Key
ROBERT C. STANTON, MDAssociate Professor of Medicine
Harvard Medical SchoolChief of Kidney and Hypertension Section
Joslin Diabetes Center
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Disclosures
Ø I have no disclosures that are relevant to the information discussed in this presentation.
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Learning ObjectivesØ Understand The Scope Of Chronic Kidney Disease in the USA
Ø Understand How To Screen For And Monitor Progression Of Chronic Kidney Disease (CKD)
Ø Know Latest Approaches For Prevention of CKD
Ø Know Latest Approaches For Treatment of CKD
Ø Review Information on Newer Hypoglycemic Medications and Renoprotection
Ø Understand When To Refer To A Nephrologist
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Numbers of Patients on Dialysis-USA: 1992
www.usrds.org
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Numbers of Patients on Dialysis-USA: 2002
www.usrds.org
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2017AnnualDataReportVolume2,Chapter1 6
vol2Figure 1.9Mapoftheadjusted prevalence ofESRD,byHealthService Area, intheU.S. population, 2011-2015*
Data Source:Specialanalyses, USRDS ESRDDatabase. Standardized forage,sex,and race.Thestandard population wastheU.S.population in2011.*ThreeHealth ServiceAreasweresuppressedbecausetheratio ofunadjusted ratetoadjusted rate oradjusted ratetounadjusted ratewasgreater than 3.Valuesfor cellswith 10orfewerpatients aresuppressed.Abbreviation: ESRD,end-stage renaldisease.
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2017AnnualDataReportVolume2,Chapter1 7
vol2Figure 1.8 Trends inthenumber ofESRDprevalent cases, bymodality, intheU.S. population,1980-2015
Data Source:ReferenceTableD.1.Abbreviation: ESRD,end-stage renal disease.
ALL ESRD
HEMODIALYSIS
TRANSPLANT
PERITONEAL DIALYSIS
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2016 Annual Data Report, Vol 2, ESRD, Ch 1
8
DataSource:ReferenceTable B.2(2)and specialanalyses, USRDSESRDDatabase. *Pointprevalence onDecember 31ofeachyear.Adjusted forage,sex,andrace.Thestandard population wastheU.S.population in2011.Abbreviation: ESRD,end-stagerenal disease.
Figure1.16Trendsinadjusted*prevalence(permillion)ofESRD,byprimarycauseofESRD,intheU.S.population,1996-2014
DIABETES
GLOMERULONEPHRITIS
HYPERTENSION
CYSTIC KIDNEY DISEASECOPYRIG
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2017AnnualDataReportVolume2,Chapter1 9
vol2Figure 1.11Trends inadjustedprevalence ofESRD,byrace, intheU.S. population, 2000-2015
Data Source:ReferenceTableB.2(2)andspecial analyses, USRDSESRDDatabase. Point prevalence onDecember 31ofeachyear.Standardized forageandsex.Thestandard population wastheU.S.population in2011.Abbreviations NH/PI:Native Hawaiian/Pacific Islander; AI/AN:AmericansIndian/Alaska Natives; ESRD, end-stagerenal disease.
AFRICAN-AMERICAN
NATIVE HAWAIIAN/PACIFIC ISLANDER
AMERICAN INDIAN/ALASKA NATIVES
ASIANWHITE
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2017AnnualDataReportVolume2,Chapter1 10
vol2Figure 1.12Trends intheadjustedprevalence ofESRD,byHispanic ethnicity, intheU.S. population, 2000-2015
Data Source:ReferenceTablesB.1,B.2(2).Point prevalence onDecember 31ofeachyear.Standardized forage, sex,andrace.Thestandard population wastheU.S.population in2011.Abbreviation: ESRD, end-stagerenal disease.
HISPANIC
NON- HISPANIC
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Kidney Disease: 2016 DataØ About 14.8% of the U.S. population has chronic kidney disease (CKD) as
defined as GFR of < 60 mL/min or elevated urine albumin level
Ø Pacific Islanders/Native Hawaiians, African-Americans, Native American Indian, Hispanic Population, and Asian Population Have Higher Risk as
Compared to Caucasians
Ø 726,331 patients are on dialysis or have a kidney transplant Ø (as of 12/31/2016)
Ø 13 Fold Increase since 1980 – Diabetes is Main Cause
Ø Medicare spent $37 billion in 2016 on ESRD , which is about 7.3% of the Medicare budget. And an additional $79 billion was spent on CKD
Patients (Increase of 16% since 2015)
www.usrds.org
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Use Nephelometry (An Antibody-Based Method Used to Determine Specific Protein Level) to Measure Microalbumin
as Dipsticks are Relatively Insensitive and May Miss Low (but significant) Increases in the Urine Abumin Level
Measure eGFR and
Spot Urine Albumin/Creatinine Ratio (microalbumin test)
At least Yearly COPYRIG
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Importance of Knowing GFR
Ø Drug Dose Adjustments May be Needed
Ø Increasing Cardiovascular Disease Occurs as GFR Declines
Ø Increased risk for Contrast Dye Nephropathy as GFR Declines
Ø Complications of Kidney Disease (e.g., anemia, hyperparathyroidism) are seen with increasing frequency at GFR
<60ml/min COPYRIG
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Value of Graphing GFRCreatinine was 1.0 in 2004 and now 1.5
GFR Declined from 60 to 35 over 9 Years
-2.8 ml/min/year
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Ø Kaiser Permanente Study of 36,195 Participants with eGFR 30-59 ml/min
Ø 1 in 4 with Diabetes and 1 in 7 without Diabetes were Fast Progressors
Ø Proteinuria
Ø Elevated Systolic Blood Pressure
Ø Heart Failure
Ø Anemia
Ø Smoking (current or past) in Non-diabetic patients
Predictors of Fast Progression (2 Year Study)
(>4 ml/min/year)
Go et al BMC Nephrology 19:146, 2018
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ALWAYS CALCULATE eGFR
AND
GRAPH eGFR OVER TIMECOPYRIG
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Albuminuria
Ø Normal Albumin Excretion by Nephelometry is an Albumin/Creatinine Ratio of <30 mg/g
Ø Microalbuminuria – 30–300 mg/g
Ø Macroalbuminuria – >300 mg/gCOPYRIG
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eGFR May Decline in People with Normoalbuminuria
Vistisen et al Diabetes Care, In Press 2019
Normoalbuminuria(1.9 ml/min/yr)
Normoalbuminuria(1.9 ml/min/yr)
Microalbuminuria(2.3 ml/min/yr)
Microalbuminuria(2.1 ml/min/yr)
Macroalbuminuria(3.3 ml/min/yr)
Macroalbuminuria(3.0 ml/min/yr)
Normal Rate of Decline in eGFR is 0.5-1.0 ml/min/year
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Increasing Albuminuria and Decreasing GFR Are Associated with Increased
Cardiovascular and Renal Events in Type 2 Diabetes
Ninomiya T et al J. Am. Soc. Neph. 20:1813-1819 (2009)
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Albuminuria appears to be a marker of generalized inflammation and
endothelial dysfunction.COPYRIG
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Albuminuria/Proteinuria Are Independent Risk Factors for
Progression of Kidney Disease and Development and Progression of
Cardiovascular DiseaseCOPYRIG
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Causes of Chronic Kidney DiseaseØMost Common Causes – Diabetes Mellitus,
Hypertension and Glomerulonephritis • (IgA Nephropathy, Minimal Change Disease,
Membranous GN, and Focal and Segmental Glomerulosclerosis)
• Diagnosis May Require a Kidney Biopsy – Depends on History, Serology, and UrinalysisCOPYRIG
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Ø Type 1 Diabetes Duration of <5 yearsØ Absence of Diabetic RetinopathyØ Low Hemoglobin A1cØ Active Urine Sediment Ø Rapidly Declining GFRØ Rapidly Increasing or Very High Urine Protein Level
Liang et al PLOS ONE 1 May 2013 | Volume 8 | Issue 5 e64184
Although Diabetes is the Most Common Cause of Kidney Disease, it is important to remember that just because
someone has diabetes and kidney disease, does not mean they have diabetic kidney disease.
Reasons to Consider Kidney Diseases Other than Diabetes in People with Diabetes
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Use Nephelometry to Measure Microalbumin as Dipsticks are Relatively Insensitive and May Miss
Low (but significant) Increases in the Urine Abumin Level
Measure eGFR and
Spot Urine Albumin/Creatinine Ratio (microalbumin test)
At least Yearly COPYRIG
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Prevention of Kidney Disease
Ø Blood Glucose Control if Diabetic• A1c <7%
Ø Blood Pressure Control• <130/80
Ø Possibly Stopping Smoking
Diabetes and Hypertension are Main Causes
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De Boer Diabetes Care 37: 24-30, 2014
25 Year Follow Up of DCCT/EDIC –50% Reduction of Microalbuminuria in
Original Intensively Treated Group
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De Boer Diabetes Care 37: 24-30, 2014
25 Year Follow Up of DCCT/EDIC –50% Reduction in eGFR <60 ml/min in
Original Intensively Treated Group
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ACE inhibitors or ARBs should be given to diabetic patients to prevent the development
of diabetic kidney disease.
1. True2. FalseCOP
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No Primary Prevention of Development of Microalbuminuria by Enalapril or Losartan
Mauer et al N Engl J Med.; 361:40-51, 2009
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No Primary Prevention of Diabetic Kidney Disease by Enalapril or Losartan
Mauer et al New England Journal of Medicine 361:40-51, 2009
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Comparison of Prevention Trials for ACE-I or ARB in Type 2 Diabetes Mellitus
Bilous et al Ann Intern Med.151:11-20, 2009
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No Clear Benefit for ACE-I/ARB for Primary Prevention in People with Type 2 Diabetes
Ø 70-90% of People with Type 2 Diabetes will not Develop Kidney Disease
Ø Is it Reasonable to Treat Everyone with Diabetes with an ACE-I or ARB knowing that most will never
Develop Kidney Disease?COPYRIG
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There is no unique Indication for ACE Inhibitors or ARBs for Primary
Prevention of Kidney Disease in Diabetic Patients.
ACE Inhibitors and ARBs are definitely Indicated for Patients with
Albuminuria/Proteinuria
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Prevention of Kidney Disease
Ø Blood Pressure Control• <130/80
Ø Blood Glucose Control if Diabetic• A1c <7%
Ø Possibly Stopping Smoking
Diabetes and Hypertension are Main Causes
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Treatment of Chronic Kidney Disease
There are Specific Treatments for Many Diseases –Immunosuppressive Drugs, Steroids,
Plasmapheresis, Etc.
This Talk is Focused on Treatments that May Be Used for All Chronic Kidney Disease Patients
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Treatment for Chronic Kidney Disease
Ø Blood Pressure <130/80
Ø Lower Urine Albumin Ø (If >300mg/g)
Ø Possibly Stopping Smoking Ø (No Controlled Studies)
Ø If Diabetic - Tight Glucose Control - A1c < 7.0%
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Blood Pressure Goal
Ø Blood Pressure Goal for Prevention and Treatment of Chronic Kidney Disease: <130/80
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ACCORD Trial: No Benefit of Tight BP Control on Cardiovascular Outcomes – Goal Set at <140/80 in 2010
Accord Study Group. N Engl J Med;362:1575-1585, 2010
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SPRINT – Systolic Blood Pressure Intervention Trial - (Improved CV Outcomes in Intensive BP Group (<120 mmHg) vs Less Intense
Control (<140 mmHg) in Subset with CKD
Cheung et al J Am Soc Nephrol 28: 2812-2823, 2017
COMBINED CV OUTCOMES
ALL CAUSE MORTALITY
SPRINT Participant Characteristics:
>50 yo
28.2% >75 yo
Increased CV Risk
No Diabetes Mellitus
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Analysis of ACCORD Study (Type 2 DM Participants) Study Using SPRINT Criteria Show Improved CV Outcomes in Intensive BP
Group (<120 mmHg) vs Less Intense Control (<140 mmHg)
Buckley et al Diabetes Care September 25, EPUB, Ahead of Print, 2017
COMBINED CV OUTCOMES:
CV Death, Nonfatal MI, Nonfatal Stroke
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Meta-analysis of 18 Randomized Control Trials with CKD Stage 3 to 5 shows Intensive Control (Systolic Mean of 132 mmHg) is Better
than Less Intensive (Mean 140 mmHG) for Mortality
Malhotra et al Clin JAMA Internal Medicine 177: 1498-1505, 2017
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What is the Initial Drug Choice for Hypertension Control in CKD Patients?
Ø Most Guidelines recommend starting with an ACE-I or ARB
Ø But I don’t care! Individualize the treatment. It doesn’t matter unless there is increased urine protein as it often
takes multiple drugs to achieve BP goals.
Ø Choose a medication on the following:• Cost• Age
• Co-morbidities• Side Effects
Ø If increased urine protein then consider starting with an ACE Inhibitor or ARB.
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ALL OFFICE BLOOD PRESSURES (INCLUDING THOSE TAKEN IN MY OFFICE) ARE WRONGØ PROPER WAY TO TAKE BLOOD PRESSURE:
ØRESTING FOR AT LEAST 5 MINUTES
ØUSE PROPER CUFF SIZE
ØUSE BARE ARM RESTING AT HEART LEVEL
ØTAKE MULTIPLE MEASUREMENTS AND AVERAGE RESULTS
ØCHECK ORTHOSTATIC BLOOD PRESSUREDrawz and Ix J Am Society of Nephrology October 19 EPUB, Ahead of Print, 2017
DeBoer et al Diabetes Care 40:1273-1284, 2017
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Blood Pressure Goal for People with CKD
Ø Blood Pressure Goal for Prevention of and Treatment for Kidney Disease is <130/80
Ø But Individualize the Goals!!COPYRIG
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Lowering Urine Albumin Level is a Goal for Slowing Progression of Kidney Disease and Reducing
Cardiovascular Risk.
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Renin-Angiotensin-Aldosterone System Inhibitors Are Mainstays of
Treatment for Chronic Kidney DiseaseCOPYRIG
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ACE inhibitors and ARBs are ideal medications for protecting kidney function because they lower blood pressure, lower
urine albumin level, and increase GFR.
1. True2. FalseCOP
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The greater the initial decline in GFR after starting Losartan, the slower the rate of
decline in long term GFR
Holtkamp FA et al Kidney International 80:282-287, 2011
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Decreases of >10% in eGFR after Initiation of RAAS Inhibitor was Associated with Worse
Long Term Outcomes
Fu EL et al Clinical Journal of the American Society of Nephrology 14:1336-1345, 2019
>30% >30%
<10% <10%
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ONTARGET Trial suggested that ACEs and ARBs are not Synergistic and should Not be used in Combination
On TARGET Investigators NEJM 358:1547-1559, 2008
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Meta-Analysis Reports Best Outcomes with ACE-I/ARB Combination
Palmer et al The Lancet 385:2047-2056, 2015
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Patiromer and Sodium Zirconium Cyclosilicate – Oral Daily Packets to Treat Hyperkalemia
Weir et al NEJM 372:211-221, 2015
Patiromer Data
Not Indicated for Acute Treatment of Hyperkalemia
Allows for Continued Use of RAAS Inhibitors by Lowering Potassium
Expensive!
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When Should You Stop the ACE-I or ARB?Ø I don’t know
ØFor now, I tend to keep using them as long as the slope of GFR decline is slow and steady
ØSTOPACEi Study at University of Birmingham, United Kingdom
• (Stopping ACE-I or ARB (or not) at CKD Stage 4 –eGFR <30 ml/min)
Bhandari et al. Nephrology, Dialysis, and Hypertension 31:255-261, 2016
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Ø All patients with increased urine albumin (or total protein) should be on an ACE-inhibitor or an Angiotensin Receptor Blocker even if the patient has excellent blood
pressure
Ø Use of ACE-I and ARB Combination is in Flux.
Ø Reasonably strong evidence for using ACEi/ARB combination in patients with kidney disease and high
levels of proteinuria (>1 gram).
Use Of ACE Inhibitors/ARBS
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Renin-Angiotensin-Aldosterone System
Postgraduate Med, 2009
Spironolactone
Beneficial for both Cardiac and Kidney Disease.
Appears to be safe in combination with ACE-I or ARB.
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Persistently High Aldosterone has Many Deleterious Effects
(Independent of Effects on Sodium and Potassium)
Schrier Clin J Amer Soc Neph; 5:1132-1140, 2010
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Mineralocorticoid Inhibition Improves Urine Albumin Level When Added to ACEi or ARB.
No Clear Effect on Slope of eGFR
Sun et al. Journal of Diabetes Investigation 8:609-618, 2017
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Mineralocorticoid Inhibition
Mineralocorticoid Alone or in Combination Appears to be Safe and Effective – Monitor Potassium Levels
Newer Nonsteroidal Inhibitors in Clinical Trials Finerenone
Esaxerenone
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Other Treatments that Lower Albuminuria/Proteinuria that are not
Part of the RAASCOPYRIG
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Nondihydropyridine Calcium Channel Blockers Lower Urine Protein
Bakris et al. Kidney International; 65:1991-2002, 2004
NDCA
DCANDCA
DiltiazemVerapamilCOP
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Is there a role for Low Protein diets?Ø Low Protein Diet (<0.8 g/kg/day)
Ø In animal studies, a sustained low protein diet lowers glomerular pressures and can slow
progression
Ø Low protein diets have not been shown to be effective in humans. Possibly because it is very
hard to stay on a low protein diet
Ø High protein intake is associated with worsening renal disease
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High Protein Intake Is Associate with Faster Decline in eGFR
Cirillo et al Nephrol Dial Transplant (2014) 29: 1733–1740
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Serum Bicarbonate Levels of <22 mEq/L are Associated with Worse CKD Outcomes
Shah et al. Am J Kidney Disease; 54:270-277, 2009
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Allopurinol and Uric Acid
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Many Studies Have Shown an Association of Increased Uric Acid with Development and
Progression of Diabetic Kidney Disease
Hovind et al Diabetes 58:1668-1671 ,2009
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Preventing Early Renal Loss in Diabetes(PERL Study)
Ø Unclear if Uric Acid is Only a Marker or Causally Linked to Diabetic Kidney Disease
Ø PERL Study: Multicenter Study Using Allopurinol to Slow Progression of Diabetic Kidney DiseaseØ(eGFR 40-99 ml/min with albuminuria)
Ø 530 Participants – Type 1 Diabetes
Ø Results Reported Confidentially on September 26, 2019Ø To Be Presented In November at American Society of
Nephrology Meeting
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GLP-1 Agonists, DPP-4 Inhibitors, and SGLT2 Blockers
Are These Medications Renoprotective?
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Liraglutide Lowers Urine Albumin Level (No Change in eGFR)
Mann et al NEJM 377:839-848, 2017
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DPP-4 Inhibition – No Unique Benefit for Kidney or Cardiovascular Protection
Linagliptin – CARMELINA Study
Rosenstock et al JAMA 321:69-79 ,2018
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GLP-1 Agonists/DPP-4 Inhibitors
GLP1 Agonists May Lead to Lowering Urine Albumin Level
No Unique Renal Benefit for DPP-4 Inhibitors
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SGLT2 Inhibitors
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Effects of SGLT2 Inhibitors
Bommel et al Wanner et al Clinical J. Amer. Soc. Nephrol. In Press, 2017
*Mudialar et al Diabetes Care:1115-1122, 2016
*Changes Cellular
Fuel Metabolism
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Empagliflozin (SGLT2 Inhibitor) Slowed Decline in eGFR
Wanner et al NEJM 375:323-334, 2016
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Canagliflozin Slowed Decline in eGFR and Improved Albuminuria (CREDENCE)
Perkovic et al NEJM 380:2295-2306, 2019
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SGLT2 Inhibitors
The CREDENCE results Combined with the Cardiovascular Results are Understandably Exciting
for New Treatments for Diabetes Patients
But I have Concerns about the Kidney Data
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SGLT2 InhibitorsConcerns: Is it Safe to Have Persistently Very High Levels
of Glucose Passing Through the Nephron for Years?
Advanced Glycation End Product Formation is Likely Occurring in the Distal Nephron – What is Effect Over
Time?
Yet People are Born without the SGLT2 Transporter and Appear to Be Healthy
But Very Few People are Born without the SGLT2 Transporter – and Likely None with Diabetic Kidney
Disease
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Most of the Positive CREDENCE Results are Based on Slowing of eGFR Decline
Could There Be Another Explanation for Observed eGFR Changes in CREDENCE?
Hypothesis: There is an initial decline in Glomerular Filtration (similar to ACEi/ARB effect) but then there
is a subsequent Glomerular Hyperfiltration
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Initial Decline in eGFR is Likely Due to Enhanced Tubulo-Glomerular Feedback (TGF)
Cherney et al Circulation 129:587-597, 2014
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Chronic Glucose Perfusion in Mice Led to Increased SGLT1 Expression in Macula
Densa Caused Glomerular Hyperfiltration in Mice
SGLT1 Overexpression
Zhang et al Journal of the American Society of Nephrology 30:578-593, 2019
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Mouse Study Showed that Persistent Glucose Infusion Led to an Increase in SGLT1 Expression at the Macula
Densa and Glomerular Hyperfiltration
Zhang et al Journal of the American Society of Nephrology 30:578-593, 2019
*Changes Cellular
Fuel Metabolism
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SGLT2 Inhibitor Hypothesis
Hypothesis: SGLT2 Inhibitors Cause Initial Decrease in eGFR via Tubuloglomerular Feedback.
Then Chronic Glucose Exposure Leads to Increased SGLT1 Expression in Macular Densa Causing
Glomerular Hyperfiltration
Glomerular Hyperfiltration May Be Deleterious in the Long Term
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SGLT2 InhibitorsSGLT2 Inhibitors Provide Apparently Significant
Benefit for Cardiovascular Protection
They also Appear to Provide Renoprotection.
But will these Drugs Lead to Renal Damage in the Long Term
New Empagliflozin and Dapagliflozin Studies: Chronic Kidney Disease with and without Type 2
Diabetes Mellitus
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Ø Blood pressure control Goal <130/80
Ø Stop smoking
Ø Hemoglobin A1c of <7% if Diabetic
Ø Monitor GFR and Urine albumin/creatinine ratio at least once per year (Repeat if Abnormal)
Prevention of Kidney Disease
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Ø Blood pressure control <130/80 (possibly lower)
Ø Lower albuminuria/proteinuria
Ø Blood glucose control, if diabetic
Ø Dietary interventions as indicated:– Low Salt intake and avoid high protein intake
– Little to no role for low protein diet
– Avoid High Protein Diet
Ø Stop smoking
Ø Treat with Bicarbonate if Serum Level <22 mEq/L
Ø Consider Use of SGLT2 Inhibitors
Ø Check for Anemia and Hyperparathyroidism
Treatment of Kidney Disease
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What needs to be Monitored in CKD Patients
Ø Estimated GFRØ Albuminuria/ProteinuriaØ Blood PressureØ Volume Status (hyper- or hypovolemia)Ø Electrolytes (Na+, K+, HCO3)Ø AnemiaØ Hyperparathyroidism and Vitamin D DeficiencyØ MalnutritionØ Uremia (Symptoms – e.g. appetite loss, weight
loss, itching)Ø Drug Dosing
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Consult Nephrology: GFR <60 ml/min (or <45 if older than 60) or Rising Albuminuria
for Diagnosis and TreatmentØ Assistance in diagnosisØ Assistance in optimal management to slow
progressionØ Difficult-to-control hypertensionØ Rapidly worsening renal functionØ Unexplained urinalysis findingsØ Assistance in diagnosis or management of
electrolytes, acid-base, calcium/phosphate, PTH, or management of anemia in chronic renal failure
Ø Early preparation for end stage kidney disease
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Final Comments
ØEarly Diagnosis is KEY
ØAggressive Treatment to Target Goals is KEYCOPYRIG
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