Outline. The Role of Vitamin D in CKD. Essential Role of Vitamin D. Mechanism of Action of Vit D. Mechanism of Action of Vit D 7/16/2010

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1 Outline The Role of Vitamin D in CKD Priscilla How, Pharm.D., BCPS Assistant Professor National University of Singapore Principal Clinical Pharmacist National University Hospital (Pharmacy and Nephrology, Medicine) Vitamin D Sources and metabolism Mechanism of action and its essential role Vitamin D deficiency in general population and in CKD patients Causes and consequences Supplementation and treatment Effects of Vitamin D on mortality 1 2 Vitamin D - Sources & Metabolism Mechanism of Action of Vit D Vit D sources - Sunlight - Diet - Supplements Measure of Vit D stores Regulated by Ca, P, PTH & FGF23 Active Vit D Renal production of 1,25(OH) 2 D (calcitriol) GI: Enhance Ca absorption Bone: Release Ca and P into circulation Parathyroid gland: Inhibits PTH production Hydroxylation to become inactive calcitroic acid 3 Holick M. NEJM Mechanism of Action of Vit D Essential Role of Vitamin D Non renal production of 1,25(OH) 2 D Macrophages, brain, colon, breast, prostate, vasculature, pancreas etc Control cell growth and cellular differentiation Inhibit cancer cell growth, induce cancer cell maturation, apoptosis and decrease angiogenesis Inhibits renin production in kidney Immunomodulatory activity on monocytes and activated T,B lympocytes System Gastrointestinal Skeletal Endocrine Renal Immune Cardiovascular Potential Effects on Outcomes Maintains normal bone formation Decrease fracture risk Regulation of growth factor and cytokine synthesis and signaling Reduced risk of cancer, DM Decreased hyperparathyroidism Protects and preserves renal function Improves immune function Reduce inflammation, atherosclerosis, myocardial hypertrophy, heart failure Decrease morbidity and mortality, improve patient outcomes 5 Andress DL. Semin Dial 2005; Al-Badr W et al. CJASN

2 Vitamin D Deficiency Vitamin D Deficiency in Asia Serum levels of 25-hydroxyvitamin D, 25(OH)D, are the measure of body stores of vitamin D Definition: Serum 25(OH)D (ng/ml or mcg/l) In General KDOQI Sufficient 30 >30 Insufficiency Deficiency < (mild) < 5 (severe) Prevalence Widespread and global problem 1 billion people worldwide have Vit D insufficiency/deficiency US, Europe, Middle East, India, Australia, Asia Widespread prevalence all age groups and genders across South Asia Vit D status in Southeast Asian countries has received less attention Less severe? Closer to equator? Sun-rich? Postmenopausal women: Thailand 47%, Malaysia 49%, Japan 90%, South Korea 92% 25(OH)D levels lower in Malays than Chinese Younger women: Jakarta and KL > 60% More Malays and Indians had suboptimal Vit D levels Vit D status in Japan is better (fish consumption?) 7 Mithal A et al. Osteoporos Int 2009; Lim SK et al. Curr Med Res Opin 2008; Green TJ et al. Eur J Clin Nutr 2007; Rahman et al. Asia Pac J Clin Nutr 2004; Nakamura K Nutrition Causes of Vitamin D Deficiency Consequences of Vit D Deficiency Decreased skin synthesis Geographical (latitude, season, time of day) Aging, melanin content in skin Sunscreen use, indoor lifestyle, clothing Decreased bioavailability Malabsorption Obesity Increased catabolism Drugs (anticonvulsants, immunosuppressants, steroids) Decreased 25(OH)D synthesis Liver disease Increased 25(OH)D losses Proteinuria Decreased 1,25(OH) 2 D synthesis Chronic kidney disease Other disorders Hyperthyroidism, primary hyperparathyroidism, granulomatous diseases Skeletal Osteomalacia Rickets Osteoporosis Increased fracture risk Non-Skeletal Cancer Diabetes Autoimmune disease Cardiovascular disease Infections Schizophrenia, depression Muscle weakness, falls 9 10 Vitamin D Repletion/Supplementation Vitamin D Repletion/Supplementation Vitamin D 2 Vitamin D 3 Synonym Ergocalciferol Cholecalciferol Structure Extra methyl group Double bond C22-C23 Source UV radiation of ergosterol (plant sterol) from yeast Synthesized in skin from UV radiation and mushrooms Foods e.g. oily fish and those fortified with vitamin D UV radiation of 7- dehydrocholesterol from lanolin Bioactivity Less More (~30% as effective as D 3 ) Equal and interchangeable (?) Dosage strength Rx-strength 50,000 IU IU High dose repletion approach 100,000 IU every 3 months, 50,000 IU 3x/week, weekly, monthly (ergocalciferol, vit D 2 ) 1000 to 4000 IU daily (cholecalciferol, vit D 3 ) Inter-individual variability exist Rule of thumb : 1000 IU of vitamin D 3 daily can increase 25(OH)D level by ~10 ng/ml Most individuals likely require daily intake of 1000IU of vitamin D 3 to achieve optimal 25(OH)D level > 30 ng/ml When to check 25(OH)D level? Steady state is normally attained 3-6 months following supplementation; check levels approx 6 months after initiating treatment 11 Binkley N et al. Endocrinol Metabl Clin N Am

3 Vitamin D and Chronic Kidney Disease Vitamin D deficiency in CKD Mineral and bone disorder (MBD) Common complication in CKD Hyperphosphatemia, hypocalcemia, vitamin D deficiency Secondary hyperparathyroidism, bone disease, vascular calcification Altered vitamin D metabolism in CKD Reduced activation of 25(OH)D by the 1-α-hydroxylase enzyme in the kidney to become calcitriol (1,25-dihydroxycholecalciferol) Decreased quantities of enzyme as a result of reduced renal mass and function Decreased delivery of 25(OH)D to kidneys Decreased amount of 25(OH)D Suppression of 1-α-hydroxylase by FGF-23, elevated serum P and PTH A majority of CKD pts have Vit D insufficiency/deficiency US: 71% (CKD stage 3), 83% (CKD stage 4), 97% (HD) Asia: 87% (PD pts in HK) Singapore (preliminary results: > 50% stage 3-4 pts) Low 25(OH)D associated with elevated PTH Al-Badr W et al. CJASN Al-Badr W et al. CJASN 2008; Gonzalez EA et al. Am J Nephrol Recommendations Vitamin D Supplementation In CKD pts with SHPT, 25(OH)D should be measured, if insufficiency or deficiency detected, initial step to control SHPT is to give Vit D repletion or supplementation Effects of Ergocalciferol and Cholecalciferol CKD stage 3 and 4 Al-Aly et al and Zisman et al: Ergocalciferol increased 25(OH)D levels in CKD stage 3-4 pts but significantly reduced PTH only in pts with stage 3 CKD Chandra et al: Cholecalciferol 50,000 IU/week x 12 weeks increased 25(OH)D levels to ~ 50 ng/ml with 31% reduction in PTH (p=ns) Moe et al: Compared cholecalciferol vs. doxercalciferol. Cholecalciferol increased 25(OH)D levels (P<0.05). Greater PTH reduction observed in doxercalciferol group (P=NS) CKD stage 5 and 5D Pts will most likely require active vitamin D due to decrease in 1-αhydroxylase concentration in kidney Little data on use of vit D to correct vit D deficiency and effect on mortality Active Vitamin D Therapy in CKD Vitamin D (D2 or D3) does not have significant activity and must be metabolized to 1,25(OH) 2 D In advanced kidney disease, the use of active Vit D or Vit D sterols is often necessary to manage SHPT 1-alphahydroxylase Vitamin D 3 25-(OH)D 1,25-(OH) 2 D Calcitriol Active Vit D Al-Aly et al, AJKD 2007; Zisman et al, AJN 2007; Chandra et al, Endocr Pract

4 Active Vitamin D Agents Types of Vit D Generic Name Features Vit D sterol Calcitriol 1,25(OH) 2 D 3 Biologically active Vit D Hypercalcemia, hyperphosphatemia Vit D prohormones Vit D analogs Alfacalcidol 1(OH)D 3 Paricalcitol 19nor-1,25(OH) 2 D 2 Doxercalciferol 1(OH)D 2 Needs to undergo 25-hydroxylation in liver to become active vit D Hypercalcemia, hyperphosphatemia Active Vit D with structural modifications More selective for VDR in parathyroid gland Less hypercalcemic and hyperphosphatemic Reduce mortality (?) Active Vit D with structural modifications Needs to undergo 25-hydroxylation in liver to become active vit D Less hypercalcemic and hyperphosphatemic than calcitriol 19 Vitamin D deficiency is associated with increased mortality Wolf et al: Retrospective cohort, cross-sectional analysis of >800 HD pts to determine correlation of vit D levels and mortality Majority of pts were vit D deficient and were associated with increased mortality Treatment with active vitamin D appears to improve survival and clinical outcomes in dialysis pts Teng et al: 20% reduction in mortality in pts who received some form of vit D (calcitriol or paricalcitol) vs. those who received none (P<0.05) Survival benefit observed regardless of Ca, P and PTH levels indicating effects of vitamin D independent of that on CKD-MBD Wolf M et al, Kidney Int 2007; Teng M et al, J Am Soc Nephrol Shoji et al: - Cardiovascular mortality reduced in pts receiving alfacalcidol Kalanter-Zadeh et al: - Paricalcitol associated with improved survival compared to those not receiving Vit D Is one type of Vit D better than the other? Teng et al: Paricalcitol shown to have improved survival advantage over calcitriol in 60,000 HD pts Tentori et al: Higher mortality in pts who did not receive Vit D (p<0.05) Similar survival benefit irrespective of active Vit D sterols (calcitriol, doxercalciferol, paricalcitol) Benefit independent of Ca, P, PTH levels Shoji T et al. Nephrol Dial Transplant 2004; Kalanter-Zadeh et al. Kidney Int Teng M et al. NEJM 2003; Tentori F et al. Kidney Int Management of CKD-MBD Pleiotropic effects of Vit D (?) Problems with Vit D studies Mostly from observational, historical cohort studies Awaiting results of randomized, placebo-controlled trial (PRIMO study) comparing effects of paricalcitol on progression or regression of LVH in stage 3-5 CKD Monitor PTH Evaluate Vit D status and treat as necessary Dietary P restriction Calcium supplements P-binders Active Vit D sterols (calcitriol, alfacalcidol, doxercalciferol, l paricalcitol) Calcimimetic Dialysate Ca Dialysis prescription Limit Ca intake Parathyroidectomy CKD Stage 3 CKD Stage 4 CKD Stage 5 23 Martin KJ et al, JASN

5 Summary Need to treat Vit D deficiency in CKD? Vit D deficiency shown to be associated with various diseases Also associated with mortality in general population and CKD Currently no data from RCTs showing reduction in mortality from vit D repletion No consensus on what defines adequate or toxic vitamin D levels Emerging information on potential role of vit D deficiency and insufficiency in pathogenesis or worsening of certain diseases Measurement of levels and treatment should be individualized Summary CKD pts with Vit D deficiency should be treated similarly as general population Use of active Vit D sterols according to KDOQI guidelines CKD stage 3-5 (predialysis pts) Correct Vit D deficiency using ergocalciferol or cholecalciferol if SHPT is present; if SHPT persists, switch to active vit D agent CKD pts on dialysis Use active vit D agents in pts with SHPT No comment on use of vit D to correct vit D deficiency Vit D should be held or dosage decreased if serum P > 5.5 mg/dl (1.78 mmol/l), PTH < 150 pg/ml (15.75 pmol/l) and CaxP > 55 mg 2 /dl 2 (4.44 mmol 2 /L 2 ) THE END 27 5

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