Secondary hyperparathyroidism in dialysis patients
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1 Secondary hyperparathyroidism in dialysis patients ( a critical approach of pharmacological treatments) Dominique JOLY Néphrologie Hôpital NECKER, Paris
2 DFG Finn WF. J Am Soc Nephrol. 24;15:271A.
3 Ca ++ Phosphates Calcitriol Ca SR? VDR VDR PTH
4 Ca ++ Phosphates Calcitriol Ca SR? VDR VDR PTH Secretion Synthesis Number of cells Hyperplasia Nodules
5 Ca ++ Phosphates Calcitriol Ca SR? VDR VDR PTH Secretion Synthesis Number of cells Hyperplasia Nodules
6 PTH High turnover Low turnover PTH
7 Low turnover PTH Target PTH : 15-3 pg/ml PTH High turnover
8 Low turnover PTH Target PTH : 15-3 pg/ml PTH High turnover Barreto KI. 28;73:771
9 Low turnover PTH Target PTH : 15-3 pg/ml PTH High turnover Fracture-free survival PTH > < 65 (mois) Coco & Rush, AJKD 2;36:1115
10 High turnover PTH Target PTH : 15-3 pg/ml Low turnover PTH
11 Low turnover PTH Target PTH : 15-3 pg/ml PTH High turnover PO -- 4 Ca ++ PO Ca ++ Ca x P elevated
12 Mortality 1.8 * RR of death * * * 1..8 * * *.6. < > * 2. * RR of death * * * < > 9. RR of death *.8.6. < Block J Am Soc Nephrol. 24;15:
13 Mortality 1.8 * RR of death * * * 1..8 * * * < > 11. * Ca RR of death * * * * < > 9. PTH 8 Ph PTHi RR of death * < Block J Am Soc Nephrol. 24;15:
14 Calcifications
15 Calcifications
16 Calcifications CAC score (EBCT)
17 CAC Score of dialysis patients
18 CAC Score of dialysis patients (1) Elevated 2,5 2, 1,5 1, 5 Contro l Coronary artery disease On Dialysis Ag e Braun et al. AJKD. 1996;27:
19 CAC Score of dialysis patients (1) Elevated 2,5 2, 1,5 1, 5 Contro l Coronary artery disease On Dialysis Ag e Braun et al. AJKD. 1996;27: Blacher et al. Hypertension. 21;38:938. London et al. NDT 23;18:1731. (2) Predicts mortality SURVIVAL Calcification score: Calcification score: 1 Calcification score: 2 Calcification score: 3.25 Calcification score: mois
20 CAC Score of dialysis patients (3) Increased by hyperca ++ - phosphatemia Braun et al. AJKD. 1996;27: Blacher et al. Hypertension. 21;38:938. London et al. NDT 23;18:1731. Chertow et al. NDT. 24;19: Coronaire (P =.1) s Ph< 5.5 Aorte (P =.16) Ph 5.5 mg/dl
21 CAC Score of dialysis patients (3) Increased by hyperca ++ - phosphatemia Braun et al. AJKD. 1996;27: Blacher et al. Hypertension. 21;38:938. London et al. NDT 23;18:1731. Chertow et al. NDT. 24;19: Block GA et al, KI 25;68: Coronaire (P =.1) s Ph< 5.5 (4) Modified by treatments T Calciu msevelame r 6 m 12 m 18 m Aorte (P =.16) Ph 5.5 mg/dl
22 CAC Score of dialysis patients (3) Increased by hyperca ++ - phosphatemia Braun et al. AJKD. 1996;27: Blacher et al. Hypertension. 21;38:938. London et al. NDT 23;18:1731. Chertow et al. NDT. 24;19: Block GA et al, KI 25;68: Coronaire (P =.1) s Ph< 5.5 (4) Modified by treatments T Calciu msevelame r 6 m 12 m 18 m Aorte (P =.16) Ph 5.5 mg/dl VITAMIN D CINACALCET CONTROL
23 Ca x P Calcifications Mortalite «There is a link» Moe S et al, KI 26;69:
24 Ca x P Calcifications Mortalite «There is a link» Moe S et al, KI 26;69: «Causality?»
25 Ca x P Calcifications Mortalite «There is a link» Moe S et al, KI 26;69: «Causality?» «Intervention studies are necessary» Vitamin D Calcimimetic agents Phosphate binders
26 1. Vitamin D Stock (calciferol, ergocalciferol) sun, food 1 generation: calcitriol (1, 25-(OH) 2 -D3) 2 generation : alfacalcidol (1-α OH-D3) doxercalciferol (Hectorol, 1-αOH-D2) 3 generation : paricalcitol (Zemplar, 19-Nor-1-α-25 (OH) 2 -D2) other
27 Calcitriol VDR VDR PTH Synthesis ipth P Ca Ca x P New vitamin D Calcitriol/ Alfacalcidol
28 Do 3 generation vitamins D have a «better biological profile»? (prospective randomized study)
29 Do 3 generation vitamins D have a «better biological profile»? (prospective randomized study) PTH (pg/ml) Calcitriol (n = 133) 1 Paricalcitol (n = 13) % of patients: > 5% reduction of PTH Paricalcitol : quicker Paricalcitol : fewer hypercalcemia / Ca x P w Sprague Kidney Int. 23;63:
30 Are 2 /3 generation vitamin D associated with a better survival in HD patients? (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted)
31 Are 2 /3 generation vitamin D associated with a better survival in HD patients? (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted) HD (prevalent) survival : paricalcitol > calcitriol Paricalcitol => mortality -16 % (,79-,9) Teng, NEJM 23; 349:446-56
32 Are 2 /3 generation vitamin D associated with a better survival in HD patients? (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted) HD (prevalent) survival : paricalcitol > calcitriol Paricalcitol => mortality -16 % (,79-,9) Teng, NEJM 23; 349: HD (incident) survival: «no differences» Tentori, KI 26; 7:
33 Vitamine D use is associated with a reduced all-cause mortality (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted)
34 Vitamine D use is associated with a reduced all-cause mortality (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted) Teng M et al, JASN HD (prevalent) under vitamin D (IV calcitriol or paricalcitol) no vitamine D HR Death =.8 ( ) Tentori, KI 26; 7: HD (incident) 46,9 % no vitamin D (calcitriol or paricalcitol) HR Death =.8 (.7-.9) Melamed, KI 26; 7: HD/DP (incident) HR Death =.74 (.56-1)
35 Vitamine D use is associated with a reduced all-cause mortality (historical cohorts, retrospective, observation of 2-3y mortality, multivariate adjusted) Teng M et al, JASN HD (prevalent) under vitamin D (IV calcitriol or paricalcitol) no vitamine D HR Death =.8 ( ) Tentori, KI 26; 7: HD (incident) 46,9 % no vitamin D (calcitriol or paricalcitol) HR Death =.8 (.7-.9) Melamed, KI 26; 7: HD/DP (incident) HR Death =.74 (.56-1) vitamin D
36 Does vitamin D use explain «better survival of HD black patients?» (prospective cohort of incident HD, 1 y mortality observation, multivariate adjustement) n Mortality (1 y) PTH (pg/ml) 25 OH (ng/ml) Vitamin D active Dose/TT White % ,2 71%,6 µg Black % ,2 88 % 1 µg Black - Hispanic White
37 Does vitamin D use explain «better survival of HD black patients?» (prospective cohort of incident HD, 1 y mortality observation, multivariate adjustement) n Mortality (1 y) PTH (pg/ml) 25 OH (ng/ml) Vitamin D active Dose/TT White % ,2 71%,6 µg Black % ,2 88 % 1 µg Black - Hispanic White
38 Does vitamin D use explain «better survival of HD black patients?» (prospective cohort of incident HD, 1 y mortality observation, multivariate adjustement) n Mortality (1 y) PTH (pg/ml) 25 OH (ng/ml) Vitamin D active Dose/TT White % ,2 71%,6 µg Black % ,2 88 % 1 µg black patients on active VD blancs
39 Vitamin D Pleiotropic effects VDR is ubiquitary Vitamin D deficiency is associated with extra-skeletal complications Insulin-resistance, Diabetes HTA, SRAA Activation, cardiac failure, stroke Cancer (prostate, colon, breast) Wang, circulation 27; 117:53
40 Vitamin D Pleiotropic effects VDR is ubiquitary Vitamin D deficiency is associated with extra-skeletal complications Insulin-resistance, Diabetes HTA, SRAA Activation, cardiac failure, stroke Cancer (prostate, colon, breast) Wang, circulation 27; 117:53 VDR and diabetic nephropathy Progression Zhang, KI 28; 73:163 Glycemia Proteinuria VDR -/- Glomerulosclérosis VDR +/+
41 Vitamin D Ongoing studies OBSERVATION INTERVENTION Native Active VD and Myopathy in HD patients
42 2. Calcimimetic agents Small organic compounds that are administered orally Act as allosteric activators rather than ligands to the CaSR Increase sensitivity of the CaSR to extracellular Ca ions Suppress PTH secretion without elevating serum calcium and phosphorus levels
43 Calcimimetic agents Cinacalcet [Ca 2+ ] Ca SR PTH Secretion Synthesis Number of cells Hyperplasia
44 Calcimimetic agents Cinacalcet [Ca 2+ ] Increase calcium sensitivity 1 Control Cinacalcet Ca SR Serum PTH (% of maximum) Secretion PTH Synthesis Number of cells Hyperplasia Serum ionized calcium (mm) de Francisco, NDT 23 AVRIL 28
45 Calcimimetic agents Cinacalcet [Ca 2+ ] Increase calcium sensitivity 1 Control Cinacalcet Ca SR Serum PTH (% of maximum) Secretion PTH Synthesis Number of cells Hyperplasia Serum ionized calcium (mm) ipth P Ca Ca x P de Francisco, NDT 23 AVRIL 28 Cinacalcet
46 Calcimimetic agents Placebo Cinacalcet Biological Effects PTH KDOQI Target B Week Calcium KDOQI Target B Week Phosphate 65 6 Ca x P KDOQI Target B Week 45 4 KDOQI Target B Week Moe SM, et al. Kidney Int. 25;67:
47 Calcimimetic agents Clinical Effects Changes in relative risk (%)* PTX Fracture -54 Hospitalization CV -39 Mortality Cunningham J et al, KI 25;68:1793-8
48 Calcimimetic agents Clinical Effects Changes in relative risk (%)* PTX Fracture -54 Hospitalization CV -39 Mortality Cunningham J et al, KI 25;68:1793-8
49 Calcimimetic agents Clinical Effects Changes in relative risk (%)* PTX Fracture -54 Hospitalization CV -39 Mortality Cunningham J et al, KI 25;68:1793-8
50 Calcimimetic agents Clinical Effects Changes in relative risk (%)* PTX Fracture -54 Hospitalization CV -39 Mortality -19 DNS Cunningham J et al, KI 25;68:1793-8
51 Calcimimetic agents Clinical Effects Meta-analysis 8 studies comparing cinacalcet vs placebo n = 1429 patients End of treatment values of PTH, Ca, Ph are lower with calcimimetics No significant effects on patient-based endpoints were demonstrated Benefits of calcimimetics remain uncertain until futher RCT become available Strippoli AJKD 26;47:715
52 Calcimimetic agents Clinical Effects IN PROGRESS EVOLVE (Evaluation of Cinacalcet to Lower Clinical Events)
53 Calcimimetic agents Clinical Effects IN PROGRESS EVOLVE (Evaluation of Cinacalcet to Lower Clinical Events) Prevalent HD N=19 PTH > 3 Ca > 2.1 mm N=19 Ca x P > 3.6 mm 2 Placebo ± P binders ± vit D Cinacalcet ± P binders ± vit D
54 Calcimimetic agents Clinical Effects IN PROGRESS EVOLVE (Evaluation of Cinacalcet to Lower Clinical Events) Prevalent HD N=19 PTH > 3 Ca > 2.1 mm N=19 Ca x P > 3.6 mm 2 Placebo ± P binders ± vit D Titration : PTH 15-3 End : 1882 events (± 2.5 years) Death MI/ ACS Pulm oedema Stroke Cinacalcet ± P binders ± vit D
55 Calcimimetic agents Clinical Effects IN PROGRESS EVOLVE (Evaluation of Cinacalcet to Lower Clinical Events) Prevalent HD N=19 PTH > 3 Ca > 2.1 mm N=19 Ca x P > 3.6 mm 2 Placebo ± P binders ± vit D Titration : PTH 15-3 End : 1882 events (± 2.5 years) Cinacalcet ± P binders ± vit D Death MI/ ACS Pulm oedema Stroke %?
56 Calcimimetic agents Clinical Effects While EVOLVE results are awaited I personnaly use calcimimetic agents in selected patients
57 Calcimimetic agents Clinical Effects While EVOLVE results are awaited I personnaly use calcimimetic agents in selected patients M PTH 15 Ca x P > 1 mg 2 /dl 2 Zerbi et al. JCEM
58 Calcimimetic agents Clinical Effects While EVOLVE results are awaited I personnaly use calcimimetic agents in selected patients M Cinacalcet 3-6 mg/j M6 PTH 15 Ca x P > 1 mg 2 /dl Zerbi et al. JCEM
59 3. Phosphorus Hennig Bland (1669) The Discovery of Phosphorus Joseph Wright
60 Phosphate? PTH HD patients General Population 2.2 Risque relatif de décès < > 9. Block JASN 24;15: Dhingra Arch Intern Med 27;167:
61 Phosphate balance in HD patients Intake 1.2 g/kg => 1 mg P Absorption 6% => 42 mg P/w Dialysis Extraction => 8 mg x 3/w Accumulation => 2 mg P /day
62 Phosphate balance in HD patients Intake 1.2 g/kg => 1 mg P Absorption 6% => 42 mg P/w Dialysis Extraction => 8 mg x 3/w Accumulation => 2 mg P /day Diet appropriate diet prevents l hyperparathyroïdism Slatopolski et al, JCI :492
63 Phosphate balance in HD patients Intake 1.2 g/kg => 1 mg P Absorption 6% => 42 mg P/w Dialysis Extraction => 8 mg x 3/w Accumulation => 2 mg P /day Diet Phosphate Binders appropriate diet prevents l hyperparathyroïdism Calcium (carbonate / acetate) Résines Sevelamer Lanthanum Slatopolski et al, JCI :492
64 Phosphate binders Serum P (mg/dl) Ca * Ca *** Sevelamer * Lanthanum ** 5.5 K/DOQI Weeks * TTG: Chertow GM. KI 22 ** Hutchison WCN 3. Berlin *** Qunibi W. Kidney Int : 1914
65 Phosphate binders «CARE Study» The Calcium Acetate Renagel Evaluation Qunibi W. Kidney Int : 1914
66 Phosphate binders «CARE Study» The Calcium Acetate Renagel Evaluation n = 1 HD Double blind 8 weeks Titration : P<5.5 Phosphate Ca x P P < 5.5 mg/dl Calcium Acetate OR = 2.37 CaP < 55 mg 2 /dl 2 Calcium Acetate OR = 2.16 Calcium Hypercalcémie Calcium Acetate OR = 6.1 Qunibi W. Kidney Int : 1914
67 Phosphate binders «CARE Study» The Calcium Acetate Renagel Evaluation n = 1 HD Double blind 8 weeks Titration : P<5.5 PTH DNS HCO3- P <,1 Tolerance DNS
68 Phosphate binders «CARE Study» The Calcium Acetate Renagel Evaluation n = 1 HD Double blind 8 weeks Titration : P<5.5 Calcium Acetate 732 $ Sevelamer 4283 $ «superior efficacy» «in occasional patients»
69 Phosphate binders Treat to Goal 2 prevalent HD Calcium Acetate Calcium Carbonate International Prospective Randomized Open 52 weeks Sevelamer Primary endpoint : Ca x P difference between binders Chertow, et al. KI :
70 Phosphate binders Treat to Goal 2 prevalent HD Calcium Acetate Calcium Carbonate International Prospective Randomized Open 52 weeks Sevelamer Primary endpoint : Ca x P difference between binders Results Primary endpoint not met (no difference between binders) Some secondary endpoints show differences: 1 hypercalcemic episode PTH suppression LDL cholesterol Aorta calcification at 52 weeks Chertow, et al. KI :
71 Phosphate binders Treat to Goal Progression of calcifications Median Percent Change Sevalame r Calcium binders 1 % Aort a Week % Week 52 5 % 28% * Chertow, et al. KI :
72 Phosphate binders Treat to Goal Progression of calcifications «calcium calcifies» Median Percent Change Sevalame r Calcium binders 1 % Aort a Week % Week 52 5 % 28% * Chertow, et al. KI :
73 Phosphate binders Treat to Goal Progression of calcifications «calcium calcifies» Median Percent Change Sevalame r Calcium binders 1 % Aort a Week % Week 52 5 % 28% * «not so sure» In the SEVELAMER group, 1) Calcium intake was probably important in the dialysate as nighttime supplements 2) LDLc was lower Chertow, et al. KI :
74 Phosphate binders Treat to Goal Sevelamer (n=99) Final Calcium (n=11) Final P Phosphorus mg/dl Calcium mg/dl Hypercalcemia % Ca P mg2/dl2 Intact PTH pg/ml LDL-C mg/dl 5.1 ± ±.7 16% 49 ± ± <.1 Chertow, et al. KI :
75 Phosphate binders CARE -2 Calcium Acetate /Sevelamer Evaluation Study 2 23 PREVALENT HD Calcium Acetate USA Prospective Randomized Open 52 weeks Sevelamer Ph mg/dl LDLc <.7 g/l (± atorvastatin)
76 Phosphate binders CARE -2 Calcium Acetate /Sevelamer Evaluation Study 2 23 PREVALENT HD Calcium Acetate USA Prospective Randomized Open 52 weeks Sevelamer Ph mg/dl LDLc <.7 g/l (± atorvastatin) Primary endpoint : CAC score (ECBT at 1 year) Hypothesis : no différence in CAC score progression
77 Phosphate binders CARE -2 Calcium Acetate /Sevelamer Evaluation Study 2 23 PREVALENT HD Calcium Acetate USA Prospective Randomized Open 52 weeks Sevelamer 3 3 % 29% Ph mg/dl LDLc <.7 g/l (± atorvastatin) Median % Change AJKD 28 in press Sevalamer Calcium binders 5 Week 52
78 Phosphate binders RIND study Renagel In New Dialysis Block GA et al, KI 27;71:
79 Phosphate binders RIND study Renagel In New Dialysis 129 INCIDENTS HD Calcium Acetate Calcium Carbonate International Prospective Randomised Open 44 weeks Sevelamer Endpoints: 1) Mortality Block GA et al, KI 27;71:
80 Phosphate binders RIND study Renagel In New Dialysis 129 INCIDENTS HD Calcium Acetate Calcium Carbonate International Prospective Randomised Open 44 weeks Renagel Endpoints: 1) Mortality Crude : 1.6/1 vs 5.3/1 (P=.5) Adjusted : HR 3.1 (p=.16) Block GA et al, KI 27;71:
81 Phosphate binders RIND study Renagel In New Dialysis 129 INCIDENTS HD Calcium Acetate Calcium Carbonate International Prospective Randomised Open 44 weeks Renagel Endpoints: 1) Mortality Crude : 1.6/1 vs 5.3/1 (P=.5) Adjusted : HR 3.1 (p=.16) Block GA et al, KI 27;71:
82 Phosphate binders DCOR «Dialysis Clinical Outcomes Revisited» 213 HD prévalents (75 centres, USA) Renagel (n=153) Calcium(n=15) Acetate 7% Carbonate 3% Suki et al. KI 27
83 Phosphate binders DCOR «Dialysis Clinical Outcomes Revisited» 213 HD prévalents Renagel (n=153) Calcium(n=15) (75 centres, USA) Acetate 7% Carbonate 3% Men 55% Black 47% Diabetes 5% HD vintage 3 y 6 y Suki et al. KI 27
84 Phosphate binders DCOR «Dialysis Clinical Outcomes Revisited» 213 HD prévalents Renagel (n=153) Calcium(n=15) (75 centres, USA) Acetate 7% Carbonate 3% Men 55% Black 47% Diabetes 5% HD vintage 3 y 6 y 45 months Mortality Power >8 % to detect a > 22% mortaliy réduction Suki et al. KI 27
85 Phosphate binders DCOR «Dialysis Clinical Outcomes Revisited» 213 HD prévalents Renagel (n=153) Calcium(n=15) (75 centres, USA) Acetate 7% Carbonate 3% Men 55% Black 47% Diabetes 5% HD vintage 3 y 6 y 45 months Mortality Power >8 % to detect a > 22% mortaliy réduction P <.1 Ca <.1 Ca x P DNS PTH <.1 LDLc <.1 Suki et al. KI 27
86 Phosphate binders DCOR All cause Mortality Cardiovascular Mortality Suki et al. KI 27
87 Phosphate binders DCOR STRATIFICATION : PATIENTS > 65 ans All cause Mortality Cardiovascular Mortality Suki et al. KI 27
88 Phosphate binders Systematic reviews
89 Phosphate binders Systematic reviews Experts opinions
90 Phosphate binders Systematic reviews 2 -ANALYSIS AJKD 28 (March) 51 : 445 Experts opinions DCOR : many patients were lost to follow up Intention to treat analysis Using Medicare/Medicaid data Reported by Separate group of investigators Overall mortality DNS Cause specific mortality DNS Morbidity DNS Cause specific hospitalisation DNS First specific hospitalisation DNS Multiple hospitalisation rate 1.7 vs 1.9* Hospital days (patient/year) 12.3 vs 13.9 *
91 HPTX TREATMENTS Ca CLINICALLY RELEVANT RESULTS Morbidity Mortality Phos
92 HPTX TREATMENTS Ca CLINICALLY RELEVANT RESULTS Morbidity Mortality Phos Desappointing Absent Awaited To be confirmed Sevelamer Cinacalcet Vitamin D Lanthanum Nicotinic Acid Calcium / dialysate
( ) , (Donabedian, 1980) We would not choose any treatment with poor outcomes
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