. Biondi-Zoccai G, Romagnoli E, Agostoni P et al. The sum of current evidence suggests an important role for phosphate retention in the pathogenesis and clinical consequences of CKD-mineral and bone disorder (CKD-MBD), a common metabolic complication of kidney disease that affects nearly all patients by the time they reach end-stage renal disease (ESRD). . Nakano T, Ninomiya T, Sumiyoshi S et al. Such trials typically avoid hypervigilant procedures for ensuring compliance with treatment, which are clinically unrealistic, may utilize a no-treatment group in place of a formal placebo and can be completed at relatively lower costs. . Implications for the renal production of 1,25-dihydroxyvitamin D, Relation between serum phosphate level and cardiovascular event rate in people with coronary disease, Relations of serum phosphorus and calcium levels to the incidence of cardiovascular disease in the community, Longitudinal relationships among coronary artery calcification, serum phosphorus, and kidney function, Serum phosphorus levels associate with coronary atherosclerosis in young adults, Serum phosphate is associated with aortic valve calcification in the Multi-ethnic Study of Atherosclerosis (MESA), FGF-23 inhibits renal tubular phosphate transport and is a PHEX substrate, Dietary phosphorus deprivation induces 25-hydroxyvitamin D, Fibroblast growth factor-23 mitigates hyperphosphatemia but accentuates calcitriol deficiency in chronic kidney disease, Common genetic variants associate with serum phosphorus concentration, Association of kidney function with coronary atherosclerosis and calcification in autopsy samples from Japanese elders: the Hisayama study, Phosphate regulation of vascular smooth muscle cell calcification, Human vascular smooth muscle cells undergo vesicle-mediated calcification in response to changes in extracellular calcium and phosphate concentrations: a potential mechanism for accelerated vascular calcification in ESRD, Chronic mineral dysregulation promotes vascular smooth muscle cell adaptation and extracellular matrix calcification, Medial artery calcification in ESRD patients is associated with deposition of bone matrix proteins, Phosphate feeding induces arterial medial calcification in uremic mice: role of serum phosphorus, fibroblast growth factor-23, and osteopontin, High phosphorus diet induces vascular calcification, a related decrease in bone mass and changes in the aortic gene expression, Kidney Disease: Improving Global Outcomes, KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), Parathyroid hormone action on phosphate transporter mRNA and protein in rat renal proximal tubules, Klotho as a regulator of fibroblast growth factor signaling and phosphate/calcium metabolism, Effects of phosphate binders in moderate CKD, Cardiovascular effects of sevelamer in stage 3 CKD, Regulation of rat intestinal Na-dependent phosphate transporters by dietary phosphate, Mineral metabolism parameters throughout chronic kidney disease stages 1–5—achievement of K/DOQI target ranges, The roles of the skeleton and phosphorus in the CKD mineral bone disorder, The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. . In a cross-sectional study of 233 prevalent US dialysis patients, the average daily pill burden was 11, of which 49% were phosphate binders [61]. This medicine will help control the amount of phosphorus your body absorbs from the foods you eat. Alexandra Voinescu, Kevin J. Martin, in Nutritional Management of Renal Disease, 2013. This possibility will be addressed by the COMBINE study, which will incorporate phosphate binders plus nicotinamide in an attempt to achieve more potent reduction in phosphate absorption. There are many different kinds of phosphate binders. Since it does not bind with phosphorus in food, it is not necessary to give it with every meal. Null effects of phosphate binders on these hormones may reflect insufficient blockade of gastrointestinal phosphate absorption, in part due to compensatory up-regulation of sodium–phosphate channels in the gut [41]. Are propensity scores really superior to standard multivariable analysis? Palmer SC, Hayen A, Macaskill P et al. To achieve this objective, such studies must first account for potential differences in characteristics between treated and untreated individuals. The result is maintenance of serum phosphate concentrations within the normal laboratory range throughout most of the course of CKD at the expense of chronic disturbances in mineral metabolism hormones. Several studies have found relatively lower risks of mortality comparing chronic dialysis patients treated with phosphate binders to similar untreated patients [46–49]. Smith DH, Johnson ES, Thorp ML et al. Current evidence supports clinical trials of phosphate binders on clinically relevant endpoints as the next appropriate scientific step. Second, disturbances in FGF-23, PTH, 1,25(OH)2D and klotho are detectable at the earliest stages of CKD, when filtration is theoretically sufficient to excrete the daily phosphate load without compensation [42, 43]. Tonelli M, Sacks F, Pfeffer M et al. . On the other hand, Mehrotra et al. Preclinical data have shown that the combination of intestinal phosphate binders with inhibitors of active intestinal phosphate transport may enhance the phosphorus-lowering. 2013 May;73(7):673-88. doi: 10.1007/s40265-013-0054-y. -, Circ Res. . -, Circulation. Epub 2020 May 8. 20. Several caveats apply to studies of serum phosphate concentrations in CKD and normal populations. Interventions to correct dyslipidemia, anemia and homocysteine elevation in kidney disease populations have resulted in either no benefit or unintended harm [63–65]. The rationales for prescribing phosphate binders to CKD patients derive from studies of serum phosphate concentrations and phosphate metabolism, not phosphate binders. Observational studies of medication use should further utilize complementary methods to those employed in clinical trials, specifically, commencing follow-up when patients first initiate therapy (incident users) and performing primary analyses according to initial treatment assignment (intention-to-treat). Such a regimen is disruptive to the already reduced quality of life of CKD patients. Curr Med Res Opin. Kestenbaum B, Glazer NL, Kottgen A et al. [ 6, 7] With … In parallel, phosphate retention directly and indirectly inhibits the synthesis of 1,25-dihydroxyvitamin D (1,25[OH]2D), the biologically important form of vitamin D, and klotho, a co-factor for FGF-23 with important implications for aging and disease [26, 38]. Interventions that correct these metabolic disturbances are typically more complex than initially understood. has received honoraria from Keryx Biopharmaceuticals over the past 12 months. randomized 38 stage III CKD patients to lanthanum carbonate versus placebo for 12 months [45]. . Clipboard, Search History, and several other advanced features are temporarily unavailable. Three recent studies compared the impact of phosphate binders versus placebo on serum phosphate concentrations, mineral metabolism hormones and subclinical cardiovascular disease measurements. . Third, coronary artery calcium detected by computed tomography is far more likely to represent calcified atherosclerosis than medial arterial calcification in non-dialysis populations [29]. Such recommendations necessarily imply some intervention (phosphate binders, dietary modification) for patients whose serum phosphate concentrations fall outside the recommended range, yet clinical evidence for such interventions is absent. Therefore, phosphate management is thought to play a pivotal role in health and longevity of CKD patients. Unfortunately, head-to-head studies that compare different medications within the same class provide no meaningful information regarding the safety or efficacy of the drug class. Summary table of randomized controlled trials examining the treatment of CKD-MBD with calcium- containing phosphate binders versus calcium-free phosphate binders: study population characteristics Table S21. As a result, oral phosphate binders are used in over 90% of patients with kidney failure, at an annual cost of approximately $750 million (in U.S. dollars) worldwide.1 Historically, treatment with oral phosphate binders was intended to prevent symp - tomatic secondary hyperparathyroidism. Moe et al. [16] found no adjusted association of serum phosphate concentrations with all-cause mortality or ESRD among 10 672 individuals who had CKD in the community-based Kidney Early Evaluation Program (KEEP) [16]. Hyperphosphatemia and phosphate binders: effectiveness and safety. doi: 10.1093/ndtplus/sfr168. Adherence to phosphate binders is variable across patients and decreases in association with a greater number of prescribed pills [62]. Some, but not all, studies have demonstrated associations of higher circulating phosphate concentrations with mortality and cardiovascular events. ASSOCIATIONS OF SERUM PHOSPHATE WITH DISEASE IN DIALYSIS POPULATIONS, ASSOCIATIONS OF SERUM PHOSPHATE WITH DISEASE IN CKD AND GENERAL POPULATIONS, EXPERIMENTAL MODELS OF VASCULAR CALCIFICATION, ROLE OF PHOSPHATE RETENTION IN THE PATHOGENESIS OF CKD-MBD, SHORT-TERM CLINICAL TRIALS USING BIOCHEMICAL AND SUBCLINICAL ENDPOINTS, HEAD-TO-HEAD STUDIES OF DIFFERENT PHOSPHATE BINDER CLASSES, Receive exclusive offers and updates from Oxford Academic, Copyright © 2020 European Renal Association - European Dialysis and Transplant Association. Kempson SA, Lotscher M, Kaissling B et al. Thank you for submitting a comment on this article. Wang S, Alfieri T, Ramakrishnan K et al. Block et al. Noordzij M, Korevaar JC, Bos WJ et al. Differences in demographics, CKD etiologies, comorbidity assessment and the timing of serum phosphate measurements, which may vary by as much as 1.0 mg/dL throughout the day [19], may have contributed to heterogeneous associations. Moreover, there were also no differences with respect to change in left ventricular mass, diastolic function, carotid-femoral pulse wave velocity or lumbar spine bone mineral density. There are no definitive clinical trials that compare phosphate binders versus no treatment on clinically relevant outcomes. Specifically, this theory posits that the loss of filtering nephrons leads to subtle phosphate retention, which subsequently signals the phosphaturic hormones parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF-23) to increase proportionate phosphate excretion through the kidneys [27, 37]. Current evidence is limited to short-term clinical trials using biochemical and subclinical endpoints, pharmacoepidemiologic studies and head-to-head studies that compare different classes of phosphate binders. It is possible that one or more phosphate regulatory factors, and not phosphate directly, is responsible for observed associations with calcification and cardiovascular events in non-dialysis populations. Pills, chewable tablets, powders, and liquids are available. Second, the distribution of serum phosphate concentrations in CKD and general populations is typically within or just above the normal laboratory range. Calcium-based binders (calcium carbonate and calcium acetate) became the binders of choice in the 1980s and 1990s. Recent findings Mehrotra R, Peralta CA, Chen SC et al. . Adherence to phosphate binders requires the consumption of multiple pills per day timed with meals and often snacks. Studies of serum phosphate concentrations with disease in non-dialysis-requiring CKD populations have yielded mixed results [11–16].  |  Advanced coronary and carotid arteriopathy in young adults with childhood-onset chronic renal failure, Serum phosphate levels and mortality risk among people with chronic kidney disease, Relationship of phosphorus and calcium–phosphorus product with mortality in CKD, Outcomes associated with serum phosphorus level in males with non-dialysis dependent chronic kidney disease, Serum phosphate and mortality in patients with chronic kidney disease, Outcomes predicted by phosphorous in chronic kidney disease: a retrospective CKD-inception cohort study, No independent association of serum phosphorus with risk for death or progression to end-stage renal disease in a large screen for chronic kidney disease, High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients, Association of serum phosphate with vascular and valvular calcification in moderate CKD, Dietary intake of phosphorus modulates the circadian rhythm in serum concentration of phosphorus. Please check for further notifications by email. In general, these studies demonstrated progressively greater risks associated with sequentially higher serum phosphate concentrations; however, heterogeneity in analytic approaches across studies precludes definitive knowledge of the functional pattern of this relationship. 2009 Oct;54(4):619-37. doi: 10.1053/j.ajkd.2009.06.004. . Therefore, at present, the prolonged use of aluminium-containing phosphate binders in patients with CKD is strongly discouraged, in accordance with recent clinical practice guidelines. Modification of Diet in Renal Disease Study Group, Effects of phosphate binder therapy on vascular stiffness in early-stage chronic kidney disease, Phosphorus binders and survival on hemodialysis, Comparative effectiveness of calcium-containing phosphate binders in incident U.S. dialysis patients, Phosphate binder use and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS): evaluation of possible confounding by nutritional status, Use of phosphate-binding agents is associated with a lower risk of mortality, Outcomes associated with phosphorus binders in men with non-dialysis-dependent CKD, Practice patterns of phosphate binder use and their associations with mortality in chronic kidney disease, In defense of pharmacoepidemiology—embracing the yin and yang of drug research, Propensity score methods gave similar results to traditional regression modeling in observational studies: a systematic review. This problem may be attenuated by newer phosphate binders such as sevelamer hydrochloride and lanthanum carbonate. People with chronic kidney disease (CKD) have a reduction in their capacity to remove phosphate from the body via the kidneys, so that phosphate levels in the blood and in body tissues increase as kidney function decreases. . First, steady-state serum phosphate levels reflect the complex interplay of regulatory hormones, cellular receptors and bone metabolic factors that serve to maintain phosphate homeostasis [25–27]. . -, J Am Soc Nephrol. . This study was supported by a grant from the National Institutes of Health R01 DK094891. Phosphate binders are medications used to reduce the absorption of dietary phosphate; they are taken along with meals and snacks. In conclusion, phosphate binders significantly lower serum and urinary phosphorus and attenuate progression of secondary hyperparathyroidism among patients with CKD who have normal or near-normal levels of serum phosphorus; however, they also promote the progression of vascular calcification. containing phosphate binders versus calcium-free phosphate binders: study characteristics Table S20. Navaneethan SD, Palmer SC, Craig JC, Elder GJ, Strippoli GF. . © The Author 2015. Similarly, for any of the available drugs, gastrointestinal adverse effects are a possible limitation and may promote non-adherence to medication. Pediatr Nephrol. Kestenbaum B, Sampson JN, Rudser KD et al. Adeney KL, Siscovick DS, Ix JH et al. Animal models provide further evidence linking phosphate overload with medial arterial calcification in kidney failure. Clinical trials that employ highly practical or ‘pragmatic’ designs represent an optimal approach for determining the safety and effectiveness of phosphate binders in real-world settings. In this review, the role of phosphate as a uraemic toxin and the advantages and disadvantages of the currently available phosphate binders are discussed. Epub 2019 Oct 30. [33] directly demonstrated a 44% prevalence of medial arterial calcification, an otherwise rare finding, in inferior epigastric arteries removed from ESRD patients undergoing renal transplantation. Navaneethan SD, Sakhuja A, Arrigain S et al. Published by Oxford University Press on behalf of ERA-EDTA. However, knowledge pertaining to serum phosphate concentrations and phosphate metabolism cannot substitute for information regarding the clinical risks and benefits of interventions that are used to reduce phosphate. Over 9 months of follow-up, phosphate binder treatment reduced 24-h urinary phosphate excretion by a mean of 22%, demonstrating reasonable compliance and expected efficacy. Giral H, Caldas Y, Sutherland E et al. However, certain aspects of experimental models temper direct application to human calcification. . . Although phosphate binders reduce serum phosphate in these patients, it remains uncertain whether they improve clinical outcomes. patients with CKD (attached). All rights reserved. For example, we demonstrated a graded association of higher serum phosphate concentrations with mortality and incident myocardial infarction among 3490 male US veterans with stage III–IV CKD [11]. For adults with stage 5 CKD who are on dialysis, it is recommended that serum phosphate levels be maintained at between 1.1 and 1.7 mmol/l. Cannata-Andia JB, Fernandez-Martin JL, Locatelli F et al. Second, animal models of phosphate loading utilize diets that contain far greater relative amounts of phosphate than a typical Western diet. First, the initiation of calcification in cell culture models typically requires substantially high concentrations of phosphate (3.0 mmol = 9.3 mg/dL) under stringent conditions. . In CKD affected animals, serum phosphate tends to increase and may become more refractory to control using dietary phosphate restriction. . In summary, existing placebo-controlled trials of phosphate binders in CKD patients, albeit small, demonstrate null effects on serum phosphate concentrations, mineral metabolism hormones and subclinical cardiovascular disease measurements over relatively short-term follow-up. The prescription of phosphate binders is motivated by evidence suggesting potential toxicity of higher serum phosphate concentrations, and by the assumption that phosphate binders can meaningfully reduce serum phosphate levels in CKD. McAlister L, Pugh P, Greenbaum L, Haffner D, Rees L, Anderson C, Desloovere A, Nelms C, Oosterveld M, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Tuokkola J, Warady B, Walle JV, Shaw V, Shroff R. Pediatr Nephrol. Chiu YW, Teitelbaum I, Misra M et al. A comparative review of the efficacy and safety of established phosphate binders: calcium, sevelamer, and lanthanum carbonate. Menon V, Greene T, Pereira AA et al. The specialist will confirm the working diagnosis. Please enable it to take advantage of the complete set of features! Dietary calcium intake does not meet the nutritional requirements of children with chronic kidney disease and on dialysis. Moderator's view: Phosphate binders in chronic kidney disease patients: a clear ‘No’ at the moment, but stay tuned. Sevelamer and lanthanum can be used in the setting of hypercalcemia, and they offer a cardiovascular mortality benefit. Subsequently, observational cohort studies of hemodialysis and peritoneal patients consistently observed associations of higher serum phosphate concentrations with all-cause and cardiovascular mortality [2–7]. Intriguingly, a number of studies have observed associations of serum phosphate with cardiovascular events, vascular calcification and cardiac valve calcification in the general population [20–24]. There is a misconception that complex methodologies (propensity scores, inverse probability weighting and instrumental variables) are mandatory for this purpose; however, standard adjustment methods yield similar validity in most situations and produce results that are easier to interpret and have greater generalizability [53, 54]. No intervention to lower serum phosphate concentrations in CKD should be approved without evidence that the intervention provides at least some clinical benefit, is generally acceptable to patients and is relatively safe over long-term use. Several findings suggest that the phosphocentric hypothesis for CKD-MBD is incomplete. Curr Med Res Opin. The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition Taskforce. This site needs JavaScript to work properly. Raggi P, Boulay A, Chasan-Taber S et al. . Epub 2015 May 15. . These processes collectively result in calcification of the medial blood vessel wall (Mönckeberg's arteriosclerosis) with resultant loss of normal vessel compliance. However, phosphate binders only minimally impacted the serum phosphate concentration (0.3 mg/dL reduction versus no change in placebo group) or serum concentrations of PTH, FGF-23 or 1,25(OH)2D. . 2008 Oct 21;118(17):1748-57 In CKD Patients With Kidney Failure (Stage 5): •  5.3 Both calcium-based phosphate binders and other noncalcium-, nonaluminum-, nonmagnesium-containing phosphate-binding agents (such as sevelamer HCl) are effective in lowering serum phosphorus levels (EVIDENCE) and either may be used as the primary therapy. Drugs. Although dietary management may be adequate to control plasma phosphate in its early stages, most patients develop hyperphosphataemia by CKD stages 3-4 and require the addition of a phosphate binder. The Chronic Renal Impairment in Birmingham Phosphate study randomized 109 stage III CKD patients to sevelamer 1600 mg three times per day versus placebo [40]. Voormolen N, Noordzij M, Grootendorst DC et al. Current evidence does not support the general prescription of phosphate binders to CKD patients. Chue CD, Townend JN, Moody WE et al. Phosphate binders are among the most common medications prescribed to patients with kidney failure receiving dialysis and are often used in advanced chronic kidney disease (CKD). This topic is beyond the scope this review. Calcium Carbonate and Calcium Acetate. Well-conducted observational studies of phosphate binder use in large CKD populations could provide welcome new knowledge regarding the real-world safety and effectiveness of these medications. Recent advancements have been made in phosphate-binder treatment. B.K. Animal models and cell culture data suggest direct calcifying effects of phosphate on vascular smooth muscle tissue. 2007 Dec;23(12):3167-75. doi: 10.1185/030079907X242719. 2009 Mar;35 Suppl 1:65-70. doi: 10.1111/j.1755-6686.2009.00052.x. 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