Kidney Disease due to Diabetes. Case. Objectives. DKD yearly updates. Objectives. Disclosures. Definition and screening for DKD
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1 Kidney Disease due to Diabetes Alessia Fornoni, MD PhD Professor of Medicine Chief, Katz Family Division of Nephrology and Hypertension Director, Peggy and Harold Katz Family Drug Discovery Center University of Miami School of Medicine Disclosures I am vice President and CSO of L&F Health LLC L&F Health LLC and affiliated companies have a patent estate covering some of the topics being presented L&F Health LLC has consulting agreements with and/or has received honoraria from Hoffman La Roche, Genentech, Mesoblast, Bristol Myers Squibb, Abbvie, Jenssen, Boehringer Ingelheim, Astra Zeneca, Pfizer, Mallinkrodt, Chemocentryx, Dimerix, Variant Pharmaceutical. Jessica W. Tsai Science 2015;350:1434 Variant Pharmaceuticals, Inc. has licensed worldwide rights to develop and commercialize hydroxypropyl beta cylodextrin for treatment of kidney disease from L&F Research Case JD is a 30 year old male with a 15 year history of type 1 DM and established retinopathy. A urine dipstick is negative for protein, but spot urine for albumin shows a concentration of 10 mg/dl ( normal values 0-15 mg/dl) in two of three urine collections. Urine creatinine is 40 mg/dl: ratio is 0.25 = 250 mg/24 hours. Objectives Definition and screening for DKD 2017 Treatment guidelines Is JD affected by DKD? Objectives DKD yearly updates Definition and screening for DKD 2017 Treatment guidelines Page 88: Microvascular complications Diabetes Care, 2017, Supplement 1
2 DKD remains the most common cause of ESRD Prevalence of Diabetic Kidney Disease (DKD) ESRD prevalence (per M) 1992 ESRD prevalence by cause USRDS deboer JAMA 2011; 305: 2532 DKD and yearly risk of death Kidney disease is among the top causes of death > 5000 Type 2 Diabetes patients Yearly risk associated CVD risk protection needs early implementation Adler et al, Kidney International, 2003;63:225 Murray et al NEJM 2013; 369: 5 Screening for DKD Natural progression of DKD in T1D At diagnosis if HTN 277 patients Type 1 DM f/u 18 yrs 75% ESRD at 20 years yearly follow up, Level of evidence B Early biomarkers are missing Copyright 2004 BMJ Publishing Group Ltd. Early Detection and Treatment are Essential Hovind, P. et al. BMJ 2004;328:1105
3 DIABETES with: Definition of DKD Abnormal urine albumin excretion >30 mg/24 hours >30 mg/g creatinine (preferred) >20 g/min and/or diabetic glomerular lesions and/or loss of glomerular filtration rate (CKD-EPI preferred) Proteinuria and GFR: risk factors for ESRD Shahinfar S et al, Kidney Int: S48-S51, RENAAL Baseline Characteristics Risk stratification Normoalbuminuric DKD Prevalence of low GFR and normoalbuminuria Numbers indicate the suggested number of visits/year KDIGO 2012, Kidney International, Issue 1, 2013 MacIsaac Kidney Int 2014; 86: 50 Natural history of albuminuria Nephrology referral and biopsy egfr<30 cc/min/1.73m 2 at diagnosis CKD care and referral for renal replacement strategies ADA Worsening proteinuria despite treatment Loss of egfr> 1cc/min/1.73m 2 /month Active urine sediment Absence of retinopathy QDOQI biopsy >30% reduction in egfr after initiation of ACEi/ARB Refractory hypertension MacIsaac, Kidney Int 2014; 86: 50 ADA recommendations, Diabetes Care, January 2016 NKF QDOQI guidelines for diabetes, AJKD 2014
4 Limitation of clinically indicated kidney biopsies Often the diagnosis In clinically indicated kidney biopsies differs from DKD Objectives Definition and screening for DKD 2017 Treatment guidelines Protocol kidney biopsies are needed to understand the disease Gonzalez Suarez ML, Thomas DB, Barisoni L, Fornoni A., World J Diabetes, 2013 Prevention and treatment of DKD Prevention and treatment of DKD American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) Metabolic and hemodynamic factors in DKD Role of BP in DKD Bakris, AJKD, 36:646, 2000 Bakris GL, AJKD, 36:646, 2000
5 Recommendations for the treatment of hypertension in DKD Role of ACEi to treat DKD % of patients with endpoints % Risk reduction of 51% P=0.006 Captopril 25mg x 3 Placebo Captopril * dialysis, transplant, death Time (year) Type I DM (207 captopril and 202 placebo) Proteinuria>500 mg/24 h Creat <2.5 mg/dl 2017 by American Diabetes Association Ian H. de Boer et al. Dia Care 2017;40: Significant effect of captopril on blood pressure The Collaborative Study Group, NEJM, 329:1456, 1993 Role of ARB to treat DKD ACEi vs CCB in primary prevention of DKD with mild hypertension Incidence of diabetic nephropathy (%) Placebo Irbesartan 150 mg Irbesartan 300 mg Time (months) P<0.001 P=NS 1715 pt type 2 DM + HTN Irb 300 mg vs amlo 10 mg vs placebo End points: doubling creatinine ESRD death F/u 2.6 years -3.3 mmhg mean BP in tx vs placebo 1204 patients, type 2 DM IDNT trial, NEJM 345:851, 2001 IRMA-2. Parving et al. N Engl J Med 2001;345:870-8 Primary end point: persistent MA BENEDICT, NEJM, 251:1941, 2004 ARB vs placebo in primary prevention of DKD with normal BP ACEi or ARB? Prospective, multicentered, double-blind study 250 patients with type 2 DM and DN Telmisartan 80 mg vs enalapril 20 mg. Five year follow-up Primary end-point: change in iohexol GFR Secondary end-points: creat, UAE, BP no difference! 3326/1905 (type 1/type2) patients. Normotensive with normoalbuminuria Candesartan versus placebo (significant effect on BP) 4.7 years follow up Primary end point: development of MA Secondary: Change in UAER Bilius R et al, DIRECT, Annals of internal medicine, 2009; 151:11-20 Barnett AH, NEJM, 351:1952, 2004
6 ACEi or ARB? Is there a role for ACEi/ARB combination in DKD in type 2 DM? ON TARGET ADA 2017: Type 1 DM with HTN and albuminuria: ACEi Type 2 DM with HTN and microalbuminuria: either ACEi or ARBs Type 2 DM with HTN and overt nephropathy: ARBs When not tolerated, substitute one for the other BP -2.4/1.4 mmhg BP -0.9/0.6 mmhg patients with CV disease or high risk diabetes Follow up for 5 years Primary renal outcome: dialysis, x2 creat, death Combination not supported Mann J et al, ONTARGET trial, The Lancet, 2008, 372: Aldosterone antagonism in DN Aldosterone antagonism in DKD Randomized trial 59 patients with type 2 DM + macroalbuminuria On ACEi or ARB mg spironolactone x 1 year Figure 3. Percentage change in median UACR from baseline to week 12, by quartile of baseline estimated glomerular filtration rate (egfr) and treatment group J Hyperten, 2006, 24:2285 Epstein, M. et al. Clin J Am Soc Nephrol 2006;1: Aldosterone antagonism in DKD: phase 2b with finerenone ARTS-DN ARTS-DN Japan Prevention and treatment of DKD American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) JAMA 2015, 314:884 Journal of Diabetes and Its Complications , DO
7 A 1 C: a real measure in CKD? Role of glycemia in type 1 DM and DKD Falsely elevated A1C: Falsely decreased A1C: Intensive treatment With A1c 7.2 Standard treatment With A1c 9.1 Uremic toxins Metabolic acidosis Decreased 1/2 life RBCs Blood transfusions EPO treatment Retinopathy Severe DR Laser Rx Microalb Severe Microalb Albuminuria Neuropathy May need to change to glycated fructosamine, glycated albumin, variation of A1C or glycosylation gap (based on A1C and fructosamine) Kovesdy CP et al, AJKD 2008, 52: 766 Cohen RM et al, Diabetes Care Jan;26(1):163-7 McCarter RJ et al, Diabetes Care Jun;27(6): DCCT: 1441 patients with type 1 DM f/u 6.5 years Insulin 3 x day or pump vs conventional (1 or 2 daily insulin injection) Primary prevention/secondary prevention Difference maintained after discontinuation of tx (7 yr follow up) -72 NEJM 1993; 329:977 Role of glycemia in type 2 DM and DKD Role of glycemia in advanced DKD Treatment with A1c 7.0 Any Diabetes Related Endpoint -12 Microvascular Endpoints Diet with A1c 7.9 Laser Rx Cataract Albuminuria UKPDS: 3867 type 2 DM Median age 54 Intensive tx (sulpha or insulin) versus diet End points: any DM related end-point, diabetes related death and all cause mortality F/u 10 years (15 years f/u had no difference in diabetes related death) Lancet 1998; 352: Ricks et al., Diabetes 61(30): , 2012 Regression of MA in type 1 DM Regression of MA in type 2 DM 216 Japanese patients with type 2 DM F/u 6 years, 3 periods of 2 years each Regression: 50% reduction MA Remission: back to NA 386 patients with persistent MA Total f/u of 4 periods of 2 years each Regression % Risk defined Reduction as 50% reduction in UAE from one period to the other Perkins, NEJM, 2003;348:2285 % Risk Reduction Araki, Diabetes, 2005;54:2983
8 A 1 C: how low can we get? A 1 C: how low can we get? 21% relative reduction in nephropathy patients, standard vs intensive (sulfa + other drugs to achieve A1C less than 6.5). Macro: CV death, MI, stroke Micro: development of alb, x 2 creat, ESRD ADVANCE trial, NEJM, 358:24, ,251 patients, standard vs intensive (mainly insulin and TZDs). 1/3 patients had prior CV event End point: CV death, MI, stroke Discontinued after 3.5 years f/u for high mortality in intensive arm. ACCORD, NEJM, 358:24, 2008 Are all anti-diabetic drugs alike? Legend: MET=Metformin, GLP1 RA= incretins, SGLT2i= glycosuric a, DPP4-i= incretins, AGi=alpha-gluc inhib, TZD=glytazones, Su= sulphanilurea, GLN= glucosaminog, COLSVL= bile acid, BCR=bromocriptin, PRAM=pramlintide Renal Absorption of Glucose and Glucagon Secretion According Glycemia to the and Presence DKD: or drug Absence class of a effect Sodium- Coupled Glucose Transporter Type 2 (SGLT2) Inhibitor. SGLT2 inhibition: is sweet urine the solution? Hattersley AT, Thorens B. N Engl J Med 2015;373: SGLT2 K Meier inhibitors Analysis of and Two Key DKD: Renal EMPA-REG Outcomes. K Meier ARB Analysis versus of Two SGLT2 Key Renal inhibitors Outcomes. IDNT EMPA-REG 39% Worsening Nephropathy: egfr<60 ml/min and/or ACR>300 mg/g 46% Composite outcome: doubling of the serum creatinine initiation of renal-replacement therapy death from renal disease Wanner C et al. N Engl J Med DOI: /NEJMoa Doubling of serum creatinine ESRD Hospitalisation for heart failure All cause mortality Doubling of serum creatinine ESRD Hospitalisation for heart failure All cause mortality Courtesy of Dr Per-Henrik Groop
9 SGLT2 inhibitors and TG feedback K Meier Liraglutide Analysis and of Two DKD: Key LEADER Renal Outcomes. trial Time to first renal event: ACR>300, x2 creat, ESRD, renal death The cumulative incidences were estimated with the use of the Kaplan Meier method, and the hazard ratios with the use of the Cox proportionalhazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; ESRD: end-stage renal disease; HR: hazard ratio. No difference in incident albuminuria! % Risk Reduction Other effects? Cherney D et al, CirculationAHA T2DM patients 3.8 yrs f/u CKD1 35%, CKD2 42%, CKD3 20% Mann J et al, NEJM 2017, 377: , 2017l Prevention and treatment of DKD Statins do not prevent GFR loss American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education CARDS study group, Am J Kidney Dis Nov;54(5):810-9 Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) Haynes R et al. JASN 2014, 25: Statins and DKD progression Prevention and treatment of DKD American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) Am J Cardiology, 2006, 97:748
10 Cigarette smoking and DKD (T1D) Prevention and treatment of DKD American Diabetes Association recommendations 2017 N C E normo micro mild moder moder ESRD HR=ns* for current smokers *Adjusted for duration of diabetes, HbA 1c and hypertension N=non-smokers, C= current smokers, E=Ex-smokers E N HR=2.39* for current smokers C N C E HR=ns* for current smokers Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis) Feodoroff et al Acta Diabetol 2016 Multifactorial intervention in type 1 DM Multifactorial intervention in type 2 DM Smoking A1C MAP ACEi 600 patients 20 years follow up 160 patients from Steno2 7.8 years tx yrs f/u Primary end point: death Sec end point: ESRD INTENSIVE: Statin ASA ACEi/ARB Exercise diet Hovind, P, Diabetes Care, 26: 1258, 2003 Gaede, P, NEJM, 358: 580, 2008 Diabetic Nephropathy Remission and Regression Team Triial (DNETT-Japan) Prevention and treatment of DKD American Diabetes Association recommendations 2017 Level of evidence A: control BP with appropriate agents (goal <140/90mmHg, <130/80 only for younger patients) control glycemia (A1C about 7%, personalized) control dyslipidemia (LDL goal < mg/dl) counsel about smoking cessation education Level of evidence B: protein intake to 0.8 mg/kg/day (more if dialysis)
11 Dietary protein intake in DKD Case Mr JD comes to you with GFR 50 cc/min/1.73m 2 Smoker Obese BP150/90 A1c 11% LDL 150 High protein diet Non smoker Exercise TIW BP130/80 A1c 6.9% LDL 70 Low protein diet Careful protein restriction in CKD 3 and above GFR loss 20 cc/min/year ESRD in 2 year GFR loss 2 cc/min/year ESRD in 20 year Hansen HP et al, Kidney International, 62:220, 2002 IT S UP TO MR JD AND TO YOU! Acknowledgments Questions? Nephrotic Syndrome Study Network Objectives DKD: Ongoing trials on new targets Definition and screening for DKD pyridoxamine SGLT2 inhibitors 2017 Treatment guidelines finerenone Novel biomarkers Allopurinol Pentoxifylline Nox1-4 CXC-140 JAK-STAT Adapted from Fineberg, D. et al. (2013) Nat. Rev. Endocrinol. doi: /nrendo
12 Is hyperuricemia a predictor of outcome? DKD: role of Vitamin D 263 patients with type 1 diabetes, 18.1 years f/u Uric acid measured 3 years after onset of diabetes 355 patients with DM and MA Baseline uric acid determination 6 years f/u End points: GFR Cystatin decline albuminuria Ficociello et al, Diabetes Care Jun;33(6): All patients NA at enrollment (23 with macroalbuminuria at f/u) Hovind P et al, Diabetes, 2009 Jul;58(7): consecutive patients in a CKD clinic (28% with DN) 6 years follow up Baseline Vitamin D adjusted for age, sex, smoking, CRP, albumin, ACE/ARB usage, egfr Ravani P et al, Kidney International (2009) 75, DKD: role of Vitamin D Role of dyslipidemia in DKD Age Age Gender Gender Race Race season Season HTN DM BMI HDL egfr Alb VitD supp CRP Melamed M et al, J Am Soc Nephrol 20: , 2009 Sacks F M et al. Circulation. 2014;129: TNF Receptors: new biomarkers T1DM T2DM Plasma metabolomic analysis of patients with type 2 DM and DKD Cumulative risk for CKD>3 in patients with T1D during 12 years of follow-up according to quartile (Q1 Q4) of circulating TNFR2 at baseline. Gohda T and Niewczas M et al, JASN, 23: , 2012 Multivariate Baseline variables Univariate TNFR1 TNFR2 TNFR1 (per IQR) 2.5 (2.1, 3.1) 1.6 (1.1, 2.2) TNFR2 (per IQR) 2.5 (2.1, 3.0) (1.2, ) (PIMA Native Americans, 193 patients) Adapted from Pavkov ME et al. KI, (Caucasian Americans, 410 patients) Adapted from Niewczas MA et al., JASN, Red circles: Common and stable metabolites Red empty circles: Common metabolites that are not stable Blue: essential amino acids Niewczas et al, Kidney International, 2014, 85:1214
13 DKD: next generation biomarkers Quiz Mr BN is a 38 yo male with a 15 years history of type 1 diabetes. His A1C is 7% and his blood pressure is 130/80. He comes to you for an upper respiratory infection that started 10 days prior. His Strep throat test is positive. You screen for DKD and find no albuminuria and normal egfr. His complement is normal. He has microhematuria. A renal U/S demonstrates a complex mass that is confirmed by biopsy to be a renal cell carcinoma. When the patient undergoes nephrectomy, the pathologist reports thickening of the glomerular basement membrane in the non-tumoral portion of the parenchima and no deposits. The likely diagnosis is: -IgA nephropathy -Post-infectious GN -Diabetic kidney disease -Alport syndrome Quiz Ms AF is a 48 yo female comes to you with uncontrolled type 1 diabetes, heart failure and new onset of severe albuminuria despite maximal dose of ramipril. She does not have diabetic retinopathy. Her urinary sediment is unremarkable and her urine ACR is 1600 mg/g. She has a normocytic anemia and normal platelet count. Her PCP send the patient to you for evaluation of DKD. Her lab work demonstrated a creatinine of 1.3 mg/dl. Which test is most likely to reveal the appropriate diagnosis? -HbA1C -A peripheral blood smear -A Congo red staining on a kidney biopsy -the presence of 2/3 urine collections with an ACR>30 mg/g Quiz Mr RN is a 35 yo male with type 1 diabetes and established DKD. He comes to you with concerns about his DKD progression. He does have established diabetic retinopathy. He is not a smoker and blood pressure and HbA1C are at target. His urinary sediment is unremarkable and his urine ACR is 400 mg/g. You test for uric acid and the value is 8 mg/dl. At this point you tell the patient that: 1- he should absolutely start allopurinol now 2- high uric acid is not a biomarker for DKD progression 3- the benefits of treating patients with DKD and high uric acid with allopurinol is being studied 4- he is at high risk to develop gout Quiz Which one of the following statements is true? 1. Nodular glomerulosclerosis is pathognomonic for DKD 2. Interstitial fibrosis and tubular atrophy is an early finding and starts before diabetic glomerulopathy becomes established 3. DKD lesions are more homogeneous in type 2 compared to type 1 diabetic patients 4. Podocytopenia correlates with albuminuria QUIZ Mr BN is 53yo male with type 2 DM and CKD 4A2 who comes to your clinic to discuss how best to slow the progression of DKD. His BP is controlled, he exercises, he quit smoking, his Vitamin D is being replaced, his metabolic acidosis is corrected. However, his HbA1C is still 8.5% and he was advised to discontinue metformin. He is asking if there is any advantage to be on one hypoglycemic agent versus another. You suggest the following: A. There is no advantage of one hypoglycemic agent versus another B. He should definitely be on a SGLT2 inhibitor given the results of the EMPA-REG trial C. At an earlier stage of CKD, either liraglutide or empagliflozin may have additional benefits on DKD progression D.He should stay on metformin
14 QUIZ Mr PG is a 62 yo male who is receiving chronic hemodialysis because of kidney failure attributed to type 2 diabetes. He is new to your practice. His blood pressure is 150/82 mmhg, Hgb is 11.5 g/dl, and HbA1c is 9.5%. He is not being treated with any hypoglycemic medicines. The patient previously took metformin and never experienced a severe hypoglycemic episode, but his PCP took him off this medicine when his egfr dropped below 45 ml/min/1.73 m 2 because of the increased risk of lactic acidosis. When Mr PG went on dialysis, his nephrologist did not start any hypoglycemic medicines. The patient takes a statin daily and erythropoietin to maintain his Hgb within the recommended range. He has good nutritional status. Which of the following statements is true? A. The apparent hyperglycemia should not be treated because HbA1c is not a reliable indicator of ambient glucose in the setting of kidney failure and the patient is otherwise in good condition. B. The use of erythropoietin and the reduced RBC lifespan seen in kidney failure causes the HbA1c to overestimate ambient glucose, so the patient is in good glycemic control and should not be treated with a hypoglycemic drug because it would increase the risk of severe hypoglycemia. C. Treatment with insulin should be considered to achieve a modest reduction in HbA1c and reduce mortality risk. D. Measure glycated albumin instead of HbA1c to assess glycemic control, as it provides a measure of intermediate term glycemic control and is not confounded by anemia and shortened red cell survival, and decide how to treat the patient after results of this test become available. QUIZ Ms AF is a 28 yo female with T1D and severe albuminuria and an egfr >60 cc/min/1.73m 2 who comes to see you for uncontrolled hypertension (160/95 mmhg). Her A1C is currently at target and she exercise regularly. She is also on a low salt diet. She recently got married and is planning to have a baby before her disease progresses. She has not been taking any blood pressure medication. You discuss with her the risk of experiencing progressive DKD should she become pregnant. Which of the following advise is correct A. She should immediately start RAS blockade B. Blood pressure targeting will affect the chance to develop major cardiovascular events but will not affect DKD progression C. Blood pressure should be targeted at 130/80 with appropriate safe agents D. A combination of ACEi and ARB would be most beneficial QUIZ Ms OL is a 46 yo male with T1D that comes to you with a 30 years history of diabetes. He is normoalbuminuric and normotensive. He is concerned that one day he may develop DKD. Which one of this is the correct advise? A. He should be placed on RAS blockade to present DKD development B. You advise the patient to undergo a kidney biopsy C. You tell the patient that his chance to develop DKD after so many years from the diagnosis of diabetes is unlikely D. you tell the patient that insulin treatment is protecting his kidneys
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