Seifert ME, de las Fuentes L, Rothstein M et al. Mechanism of action. 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. J Am Soc Nephrol. As evidence is insufficient to suggest that any 1 phosphate binder significantly impacts patient outcomes, the guidelines state that medication selection should be based on the individual patient. , it is clearly affirmed that all of the available phosphate binders are effective in lowering serum phosphate. Treatment of hyperphosphatemia in CKD essentially relies on two measures: restricting dietary phosphate intake; and use of oral phosphate binders. 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. Null findings from these studies should not discourage subsequent trials using clinical endpoints. . . 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]. If you have stage 5 CKD (and are on dialysis) For adults, your healthcare professional should offer a phosphate binder called calcium acetate first. NIH Dietary phosphate loading in mouse and rat models of kidney disease leads to medial arterial calcification across multiple vascular beds [34, 35]. . has received honoraria from Keryx Biopharmaceuticals over the past 12 months. Roman-Garcia P, Carrillo-Lopez N, Fernandez-Martin JL et al. 1 ... To help lower serum phosphorus levels and reduce the relative risk of mortality, phosphate binders are utilized. . It is reasonable that the choice of phosphate binder takes into account CKD stage, presence of other components of CKD-MBD, concomitant therapies, and side-effect profile (not graded). Demonstration of reduced rates of clinical disease in such trials could lead to important health benefits for CKD patients, whereas negative results would refocus efforts to understand and treat CKD-MBD. Pro: Should phosphate binders be used in chronic kidney disease stage 3–4? . Recent advancements have been made in phosphate-binder treatment. There are several calcium-based phosphate binders including calcium carbonate-based ones such as Pronefra, Easypill Kidney Support, Renakitin, Renate, Tums, Ipakitine or Epakitin, Renaltan, Renal/Aventi KP or those based on calcium acetate. 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]. Block et al. Nephrol Dial Transplant 2016; 31: 184–188; See related article by Zoccali and Mallamaci. . Sevelamer and lanthanum can be used in the setting of hypercalcemia, and they offer a cardiovascular mortality benefit. Please enable it to take advantage of the complete set of features! The recently approved iron-based products may have a … These processes collectively result in calcification of the medial blood vessel wall (Mönckeberg's arteriosclerosis) with resultant loss of normal vessel compliance. first demonstrated greater risks of mortality among chronic dialysis patients who had serum phosphate concentrations >6.5 compared with <6.5 mg/dL [1]. Such concentrations are far lower than those used to induce calcification in experimental models, precluding a plausible mechanism for observed associations. Where diet alone is not sufficient, the use of intestinal phosphate binders is recommended (Sparkes et al. . Pro: Should phosphate binders be used in chronic kidney disease stage 3–4? National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error.  |  Phosphate Binders Aluminum Salts. . Am J Kidney Dis. Plasma phosphate levels are important in the evolution of hyperparathyroidism and ectopic calcification in chronic kidney disease (CKD). Second, animal models of phosphate loading utilize diets that contain far greater relative amounts of phosphate than a typical Western diet. . Block GA, Hulbert-Shearon TE, Levin NW et al. [ 6, 7] With … For example, Foley et al. 2015 Oct;30(10):1843-52. doi: 10.1007/s00467-015-3125-3. COVID-19 is an emerging, rapidly evolving situation. 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]. Biondi-Zoccai G, Romagnoli E, Agostoni P et al. A central goal of pharmacoepidemiologic studies is to estimate results that would be found in randomized clinical trials of similar individuals [52]. 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. Bowe AE, Finnegan R, Jan de Beur SM et al. Stevens LA, Djurdjev O, Cardew S et al. This condition is characterized by high phosphate levels and requires phosphate-lowering agents—phosphate binders. Bryan Kestenbaum, Con: Phosphate binders in chronic kidney disease, Nephrology Dialysis Transplantation, Volume 31, Issue 2, February 2016, Pages 189–194, https://doi.org/10.1093/ndt/gfv406. 2000 Sep 29;87(7):E10-7 They are frequently used in people with chronic kidney failure (CKF), who are less able to excrete phosphate, resulting in an elevated serum phosphate. 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]. Adherence to phosphate binders is variable across patients and decreases in association with a greater number of prescribed pills [62]. Curr Med Res Opin. 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. Kempson SA, Lotscher M, Kaissling B et al. Animal models provide further evidence linking phosphate overload with medial arterial calcification in kidney failure. Alexandra Voinescu, Kevin J. Martin, in Nutritional Management of Renal Disease, 2013. Please check for further notifications by email. . 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. After 40 weeks of follow-up, there were no differences between the treatment and placebo groups with respect to serum phosphate concentrations or phosphate regulatory hormones. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Noordzij M, Korevaar JC, Bos WJ et al. B.K. 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. -, Circ Res. Epub 2020 May 8. 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). 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. 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]. 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. Dhingra R, Sullivan LM, Fox CS et al. Reynolds JL, Joannides AJ, Skepper JN et al. However, selected cardiovascular imaging modalities in these studies are subject to measurement error, require longer time periods to capture meaningful biological changes and have uncertain relationships with clinical disease in CKD populations. 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. -. 2007 Dec;23(12):3167-75. doi: 10.1185/030079907X242719. Yoshida T, Yoshida N, Monkawa T et al. Your comment will be reviewed and published at the journal's discretion. . The risks and benefits of phosphate binders cannot be inferred from association studies of serum phosphate concentrations, which are inconsistent and subject to confounding, animal-experimental data, which are based on conditions that differ from human disease, or physiological arguments, which are limited to known regulatory factors. NLM A novel polymeric phosphate binder, AMG 223 was being developed by Amgen after its June 2007 acquisition of Ilypsa. . Some, but not all, studies have demonstrated associations of higher circulating phosphate concentrations with mortality and cardiovascular events. Benefits and harms of phosphate binders in CKD: a systematic review of randomized controlled trials. Although phosphate binders reduce serum phosphate in these patients, it remains uncertain whether they improve clinical outcomes. -, Clin J Am Soc Nephrol. Mehrotra R, Peralta CA, Chen SC et al. On the other hand, Mehrotra et al. . Greater total pill burden in this study was associated with lower physical component scores on the Kidney Disease Quality of Life (KDQOL) instrument. Chronic kidney disease (CKD) is frequently accompanied by hyperphosphatemia. . For this narrative review a PubMed searched was undertaken to identify new publications on phosphate binders that had been published between January 2015 and July 2019. [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. 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. Kovesdy CP, Anderson JE, Kalantar-Zadeh K. Eddington H, Hoefield R, Sinha S et al. Click below to view dosing and additional information on each type of binder. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone, Cytomegalovirus after kidney transplantation in 2020: moving towards personalized prevention, Influence of a low-dose tacrolimus protocol on the appearance of, Fibrosis and cancer: shared features and mechanisms suggest common targeted therapeutic approaches. Tonelli M, Sacks F, Pfeffer M et al. . Linefsky JP, O'Brien KD, Sachs M et al. If you can't take calcium acetate for any reason, they should talk to you about taking a different binder called calcium carbonate. Nevertheless, there has been a progressive evolution of oral binders from aluminum, through calcium salts, and on to newer agents such as sevelamer and lanthanum carbonate. CKD-MBD, defined by disturbances in mineral metabolism hormones and associated bone disease, is one of the most common recognized metabolic complications of CKD [36]. doi: 10.1093/ndtplus/sfr168. Several studies have compared calcium versus non-calcium-based phosphate binders using a variety of endpoints [55–58]. Plasma phosphate levels are important in the evolution of hyperparathyroidism and ectopic calcification in chronic kidney disease (CKD). CLINCAL INFORMATION See Phosphate Binders Prescribing Information Sheet AREAS OF RESPONSIBILITY Specialist’s Roles and Responsibilities 1. Foley RN, Collins AJ, Herzog CA et al. Nakano T, Ninomiya T, Sumiyoshi S et al. Third, direct mechanisms by which phosphate excess stimulates the FGF-23–klotho axis remain incompletely understood. 2020 Oct;35(10):1915-1923. doi: 10.1007/s00467-020-04571-x. 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. 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. Hyperphosphataemia in patients with chronic kidney disease, particularly those on dialysis, can be ameliorated by oral phosphate binders in conjunction with dietary phosphate restriction. Giral H, Caldas Y, Sutherland E et al. 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]. 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. Several studies have found relatively lower risks of mortality comparing chronic dialysis patients treated with phosphate binders to similar untreated patients [46–49]. tain adequate nutrition (Polzin and Churchill 2016). [23] found that relatively high serum phosphate concentrations (>3.9 mg/dL) among young men and women (mean age 25 years) were associated with a greater prevalence of coronary artery calcification 15 years later [23]. An intriguing and potentially unifying hypothesis suggests that phosphate retention plays a central role in the development of CKD-MBD. Nephrol Dial Transplant 2016; 31: 196–199.). This site needs JavaScript to work properly. Phosphate binders are ubiquitously prescribed to chronic dialysis patients and sporadically prescribed to patients who have chronic kidney disease (CKD). . . Pediatr Nephrol. This study was supported by a grant from the National Institutes of Health R01 DK094891. High serum phosphate usually requires dietary measures, adequate dialysis prescription and/or phosphate binders. A comparative review of the efficacy and safety of established phosphate binders: calcium, sevelamer, and lanthanum carbonate. The demise of calcium-based phosphate binders-is this appropriate for children? . Smith DH, Johnson ES, Thorp ML et al. . Raggi P, Boulay A, Chasan-Taber S et al. 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. Some, but not all, studies have demonstrated associations of higher circulating phosphate concentrations with mortality … Finally, Seifert et al. This topic is beyond the scope this review. . 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]. To achieve this objective, such studies must first account for potential differences in characteristics between treated and untreated individuals. 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. Surprisingly, active therapy with phosphate binders modestly increased coronary artery and aortic calcification scores compared with placebo, with the largest increases observed in the calcium acetate group. observed an estimated 22% lower risk of death over 1 year of follow-up among 3186 new phosphate binder users compared with a matched group of non-users [46]. Interventions that correct these metabolic disturbances are typically more complex than initially understood. Drugs. . Thank you for submitting a comment on this article. In patients with CKD stage 5D, we suggest lowering elevated phosphorus levels toward the normal range (2C)." The addition of exogenous phosphate to cultured vascular smooth muscle cells and isolated aortic rings causes loss of the smooth muscle phenotype, expression of bone-specific markers and mineralization of the extracellular matrix [30–32]. Reliable data regarding the risks and benefits of phosphate binders must derive from studies that specifically focus on these medications, not serum phosphate concentrations or phosphate metabolism. . Current knowledge regarding phosphate metabolism in CKD provides important insight into disease mechanisms and supports future clinical trials of phosphate binders in CKD patients to determine the impact of these medications on clinically relevant outcomes. . Block GA, Klassen PS, Lazarus JM et al. 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. Many clinical trials in medicine, including nephrology, have found no benefit, or even harm, from treatments that target a single metabolite or metabolic pathway based on biomarker association studies and suspected biological significance to a disease process. A link between end-stage renal disease and cardiovascular disease? Moderator's view: Phosphate binders in chronic kidney disease patients: a clear ‘No’ at the moment, but stay tuned. 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]. 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. Hyperphosphatemia and phosphate binders: effectiveness and safety. Shroff RC, McNair R, Skepper JN et al. Clin Kidney J. CKD alters the serum concentration of thousands of metabolites, many of which are plausibly related to disease outcomes. Moderator's view: Phosphate binders in chronic kidney disease patients: a clear ‘No’ at the moment, but stay tuned. . Gutierrez O, Isakova T, Rhee E et al. 2020 Mar;35(3):501-518. doi: 10.1007/s00467-019-04370-z. . Oxford University Press is a department of the University of Oxford. Epub 2015 May 15. . There are no definitive clinical trials that compare phosphate binders versus no treatment on clinically relevant outcomes. 2009 Feb;20(2):397-404 In this regard, phosphate binders are considered the prime option; however, dietary phosphate restriction and intensified dialysis are also valuable supportive tools. Are propensity scores really superior to standard multivariable analysis? . Isakova T, Gutierrez OM, Chang Y et al. See related article by Zoccali and Mallamaci. 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. Intestinal phosphate binders that do not contain calcium are associated with a reduction of mortality in the order of 22%, compared with those that do contain calcium. Of endpoints [ 55–58 ] the already reduced quality of life of CKD patients aspects of experimental models direct! 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