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• W4253293013 abstract "Background: Mineral metabolism has emerged as an important predictor of morbidity and mortality in dialysis patients, independent of bone and muscle concerns. Several expert panels have issued management guidelines for mineral metabolism. Methods: The state of mineral metabolism (serum parathyroid hormone [PTH], phosphorus, calcium, and calcium-phosphorus product) was described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Japan, Spain, United Kingdom, and United States) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS I, 1996–2001; DOPPS II, 2002–2004). Results: A relatively modest percentage of patients fell within the guideline range for PTH (21.4% in DOPPS I, 26.2% in DOPPS II), serum phosphorus (40.8%, 44.4%), albumin-corrected serum calcium (40.5%, 42.5%), and calcium-phosphorus product (56.6%, 61.4%). Results were not dramatically different across countries. The majority of patients not within guideline ranges had high serum levels of phosphorus (51.6% in DOPPS I, 46.7% in DOPPS II), calcium (50.1%, 48.6%), and calcium-phosphorus product (43.4%, 38.6%) and low (<150 pg/mL) concentrations of PTH (52.9%, 47.5%). It was rare for patients to fall within recommended ranges for all indicators of mineral metabolism; 23% to 28% fell within guideline for at least 3 measures and only 4.6% to 5.5% of patients were within range for all 4. The risks of all-cause and cardiovascular mortality were directly and independently associated with each of the 4 indicators. Conclusion: The DOPPS provides a useful comparison benchmark for the state of mineral metabolism management of patients with kidney disease; it also affirms the association between mineral metabolism and important patient outcomes. Background: Mineral metabolism has emerged as an important predictor of morbidity and mortality in dialysis patients, independent of bone and muscle concerns. Several expert panels have issued management guidelines for mineral metabolism. Methods: The state of mineral metabolism (serum parathyroid hormone [PTH], phosphorus, calcium, and calcium-phosphorus product) was described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Japan, Spain, United Kingdom, and United States) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS I, 1996–2001; DOPPS II, 2002–2004). Results: A relatively modest percentage of patients fell within the guideline range for PTH (21.4% in DOPPS I, 26.2% in DOPPS II), serum phosphorus (40.8%, 44.4%), albumin-corrected serum calcium (40.5%, 42.5%), and calcium-phosphorus product (56.6%, 61.4%). Results were not dramatically different across countries. The majority of patients not within guideline ranges had high serum levels of phosphorus (51.6% in DOPPS I, 46.7% in DOPPS II), calcium (50.1%, 48.6%), and calcium-phosphorus product (43.4%, 38.6%) and low (<150 pg/mL) concentrations of PTH (52.9%, 47.5%). It was rare for patients to fall within recommended ranges for all indicators of mineral metabolism; 23% to 28% fell within guideline for at least 3 measures and only 4.6% to 5.5% of patients were within range for all 4. The risks of all-cause and cardiovascular mortality were directly and independently associated with each of the 4 indicators. Conclusion: The DOPPS provides a useful comparison benchmark for the state of mineral metabolism management of patients with kidney disease; it also affirms the association between mineral metabolism and important patient outcomes. END-STAGE RENAL disease is usually accompanied by profound changes in mineral metabolism that lead to clinical problems such as bone disease, musculoskeletal symptoms, and growth retardation. In addition, several recent studies have found a strong association between mortality and abnormal mineral metabolism, presumably mediated by vascular calcification and atherosclerotic occlusive disease.1Block G.A. Hulbert-Shearon T.E. Levin N.W. et al.Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients A national study.Am J Kidney Dis. 1998; 31: 607-617Abstract Full Text Full Text PDF PubMed Scopus (2116) Google Scholar, 2Hsu C.H. Are we mismanaging calcium and phosphate metabolism in renal failure?.Am J Kidney Dis. 1997; 29: 641-649Abstract Full Text PDF PubMed Scopus (179) Google Scholar Several professional bodies have promulgated guidelines for the management of altered mineral metabolism in dialysis patients, partly in response to growing evidence about the relationship with vascular morbidity and mortality.3K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney DiseaseAm J Kidney Dis. 2003; 42: S1-S201PubMed Google Scholar, 4Kessler M. Canaud B. Pedrini L.A. et al.The EBPG Expert Group on Haemodialysis. European best practice guidelines for haemodialysis.Nephrol Dial Trans. 2002; 17: 1-111Crossref Scopus (1) Google Scholar The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a useful description of guideline achievement among representative samples of hemodialysis patients in 7 countries at 2 time points. In addition, the DOPPS has confirmed and extended observations about the associations between outcomes and laboratory markers of mineral metabolism. The overall DOPPS study design has been presented elsewhere.5Young E.W. Goodkin D.A. Mapes D.L. et al.The Dialysis Outcomes and Practice Patterns Study (DOPPS) An international hemodialysis study.Kidney Int Suppl. 2000; 74: S74-S81Crossref Scopus (356) Google Scholar, 6Young EW, Albert JM, Satayathum S, et al: Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int (in press)Google Scholar Briefly, a sample of dialysis facilities was selected in each participating country so as to represent the distribution of facilities by type and geography. Within each facility, a sample of 20 to 40 patients was randomly selected. The resulting prevalent patient cross-section represented the characteristics of patients in the facility and country at the time of sampling. Clinical data were abstracted from the medical record by a study coordinator at each site, usually a dialysis nurse. Longitudinal follow-up data were acquired for a period of at least 2 years. The study was approved by national and local institutional review boards, and individualized consent requirements were followed for each country and facility. DOPPS I, conducted from 1996 to 2001, involved France (20 facilities, 540 patients in the initial cross-section), Germany (21 facilities, 505 patients), Italy (20 facilities, 561 patients), Japan (65 facilities, 2,168 patients), Spain (20 facilities, 491 patients), the United Kingdom (20 facilities, 493 patients), and the United States (142 facilities, 3,853 patients). DOPPS II, conducted from 2002 to 2004, included the same 7 countries: France (20 facilities, 512 patients in the initial cross-section), Germany (20 facilities, 571 patients), Italy (20 facilities, 576 patients), Japan (60 facilities, 1,802 patients), Spain (20 facilities, 613 patients), the United Kingdom (19 facilities, 544 patients), and the United States (79 facilities, 2,246 patients). Data from the additional countries that joined DOPPS II (Australia, Belgium, Canada, Sweden, and New Zealand) were not included in the current study because of the lack of an earlier time for comparison. The variables of interest in this study were common laboratory indicators of mineral metabolism: parathyroid hormone (PTH) concentration, serum phosphorus concentration, serum calcium concentration corrected for the serum albumin concentration, and the calcium-phosphorus product (Ca × P). Throughout the DOPPS, the majority of PTH measurements were based on an intact molecule assay; values measured with other assays were excluded from this analysis. The mineral metabolism values were evaluated in reference to practice guidelines issued by the Kidney Disease Outcomes Quality Initiative (K/DOQI) program of the National Kidney Foundation and the European Best Practice Guidelines (EBPG) drafted by the European Best Practice Guidelines Working Group. Time and location trends were evaluated by using basic descriptive statistics. In addition, patient all-cause and cardiovascular survival were modeled using Cox regression with adjustment for patient demographics and clinical characteristics, including 14 summary comorbidity measures. Cardiovascular mortality was defined as deaths attributed to acute myocardial infarction, cardiac arrhythmia, cardiac arrest (cause unknown), and atherosclerotic heart disease. Mineral metabolism indicators were entered as the predictor variables of primary interest. Robust techniques were used to correct for facility clustering effects.7Klein J. Moeschberger M. Survival Analysis Techniques for Censored and Truncated Data. Springer, New York, NY1997: 416-418Google Scholar Table 1 shows the percentage of patients within K/DOQI guideline values by DOPPS country at 2 points in time. DOPPS I measurements were performed between 1996 and 1999, before the introduction of guidelines. DOPPS II measurements were made just as the relevant K/DOQI and EBPG were finalized and disseminated. The patterns are striking and consistent across countries. A minority of patients fell within the guideline range for PTH (150–300 pg/mL [150–300 ng/L]), phosphorus (3.5–5.5 mg/dL [1.13–1.78 mmol/L]), and calcium (8.4–9.5 mg/dL [2.10–2.37 mmol/L]). A slight majority of patients fell within the guideline range for the calcium-phosphorus product (<55 mg2/dL2). There was a trend toward improvement for all measurements in most of the countries. There was no consistent pattern to the relatively modest variation observed across countries.Table 1Percentage of Patients With Laboratory Values Within K/DOQI Guideline Range, by Country and YearLaboratory MeasurePTHSerum PhosphorusSerum CalciumAlbCa × PCountry (n1/n2)DOPPS IDOPPS IIDOPPS IDOPPS IIDOPPS IDOPPS IIDOPPS IDOPPS IIFrance (540/512)23.120.544.239.135.235.461.964.5Germany (505/571)24.028.626.039.554.952.043.657.8Italy (561/576)21.729.648.846.835.947.865.268.2Japan (2,168/1,802)21.427.540.645.942.745.756.861.2Spain (491/613)21.425.943.848.637.126.356.959.3UK (493/544)20.716.438.039.632.731.555.060.1US (3,853/2,246)20.726.941.244.441.146.156.360.8Overall 7 countries (8,611/6,864)21.426.240.844.440.542.556.661.4NOTE. Among prevalent cross-sections in each region: DOPPS I: US = 1996, Europe = 1998, Japan = 1999; DOPPS II: 2002. Includes data from France, Germany, Italy, Japan, Spain, UK, and US only. n1/n2 = sample size from DOPPS I/DOPPS II. K/DOQI guideline ranges: PTH 150–300 pg/mL, serum phosphorus 3.5–5.5 mg/dL, serum calciumAlb 8.4–9.5 mg/dL, Ca × P <55 mg2/dL2. To convert PTH in pg/mL to ng/L, multiply by 1; serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; serum calcium in mg/dL to mmol/L, multiply by 0.2495. Open table in a new tab NOTE. Among prevalent cross-sections in each region: DOPPS I: US = 1996, Europe = 1998, Japan = 1999; DOPPS II: 2002. Includes data from France, Germany, Italy, Japan, Spain, UK, and US only. n1/n2 = sample size from DOPPS I/DOPPS II. K/DOQI guideline ranges: PTH 150–300 pg/mL, serum phosphorus 3.5–5.5 mg/dL, serum calciumAlb 8.4–9.5 mg/dL, Ca × P <55 mg2/dL2. To convert PTH in pg/mL to ng/L, multiply by 1; serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; serum calcium in mg/dL to mmol/L, multiply by 0.2495. Given the large fraction of patients who did not fall within the guideline ranges, it is important to understand the distribution of measurements outside the guidelines. Table 2 shows that among patients outside the guideline range for PTH, more than twice as many fell in the low (<150 pg/mL [150 ng/L]) than the high (>300 pg/mL [300 ng/L]) range. Over time, the percentage of patients with low PTH declined and the percentage with high PTH increased. Most patients outside of the serum phosphorus guideline range fell in the high-phosphorus category. The time trend shows a reduction in patients with hyperphosphatemia and an increase in patients with “normal” and low phosphorus. For calcium, most of the patients outside the guidelines had high concentrations. The percentages of patients with both low and high concentrations of serum calcium have declined modestly over time.Table 2Overall Distribution of Mineral Metabolism Laboratory Values by Time (DOPPS I and DOPPS II)Measurement (n1/n2)RangePatients (%)P ValueDOPPS IDOPPS IIPTH (pg/mL) (n1/n2 = 5,439/4,261)<15052.947.5150–30021.426.2<0.001>30025.726.3Serum calciumAlb (mg/dL) (n1/n2 = 6,892/5,780)<8.49.48.98.4–9.540.542.50.06>9.550.148.6Serum phosphorus (mg/dL) (n1/n2 = 8,263/6,383)<3.57.69.03.5–5.540.844.4<0.001>5.551.646.7NOTE. Among prevalent cross sections in each region: DOPPS I: US = 1996, Europe = 1998, Japan = 1999; DOPPS II: 2002. Includes data from France, Germany, Italy, Japan, Spain, UK, and US only. n1/n2 = sample size from DOPPS I/DOPPS II. To convert PTH in pg/mL to ng/L, multiply by 1; serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; serum calcium in mg/dL to mmol/L, multiply by 0.2495. P values indicate DOPPS I versus DOPPS II for each set of laboratory value measurements. Open table in a new tab NOTE. Among prevalent cross sections in each region: DOPPS I: US = 1996, Europe = 1998, Japan = 1999; DOPPS II: 2002. Includes data from France, Germany, Italy, Japan, Spain, UK, and US only. n1/n2 = sample size from DOPPS I/DOPPS II. To convert PTH in pg/mL to ng/L, multiply by 1; serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; serum calcium in mg/dL to mmol/L, multiply by 0.2495. P values indicate DOPPS I versus DOPPS II for each set of laboratory value measurements. Table 3 illustrates that patients rarely fall within guideline range for combinations of the 4 laboratory markers of mineral metabolism (PTH, phosphorus, calcium, and calcium-phosphorus product). In DOPPS I (1996–2001), approximately 21% of patients fell outside the guideline range for all 4 measures and only 4.6% of patients fell within the guideline range for all 4 values. By the time of data collection for DOPPS II (2002–2004), there was only a slight increase in the percentage of patients falling within guidelines for multiple measurements.Table 3Percentage of Patients Within Guidelines for Varying Numbers of Laboratory ValuesNumber of Measurements in Guideline RangeDOPPS IDOPPS IIP Value*P value is chi-square for overall distribution of number of target values met in DOPPS I versus DOPPS II (n = 4,679/3,565)020.717.8At least 179.382.2At least 254.057.6<0.001At least 323.127.5All 44.65.5* P value is chi-square for overall distribution of number of target values met in DOPPS I versus DOPPS II (n = 4,679/3,565) Open table in a new tab Table 4 illustrates the potential consequences associated with falling outside the recommended ranges for markers of mineral metabolism. All-cause and cardiovascular mortality risks were significantly and positively associated with the PTH, serum phosphorus, serum calcium, and the calcium-phosphorus product.Table 4Association Between Study Outcomes (All-Cause and Cardiovascular Mortality) and Markers of Mineral MetabolismPredictorOutcome Measure*DOPPS I (1996–2001) and II (2002–04) data; models stratified by country and adjusted for age, sex, black race, duration of ESRD, prior parathyroidectomy, serum albumin, hemoglobin, dialysis dose (spKt/V), 14 summary comorbid conditions, and predictors listed in Table 4, and year of enrollment in DOPPS, controlling for effects of facility clustering.All-Cause Mortality RR (95% CI) P ValueCardiovascular Mortality RR (95% CI) P ValuePhosphorus (per 1 mg/dL)1.04 (1.023–1.059)1.10 (1.067–1.128)<0.0001<0.0001Albumin-corrected calcium (per 1 mg/dL)1.12 (1.079–1.160)1.13 (1.065–1.196)<0.0001<0.0001Calcium-phosphorus product (per 5 mg2/dL2)1.03 (1.015–1.035)1.06 (1.041–1.072)<0.0001<0.0001PTH (per 100 pg/mL)1.01 (1.001–1.018)1.02 (1.005–1.030)0.030.007NOTE. To convert serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; PTH in pg/mL to ng/L, multiply by 1.* DOPPS I (1996–2001) and II (2002–04) data; models stratified by country and adjusted for age, sex, black race, duration of ESRD, prior parathyroidectomy, serum albumin, hemoglobin, dialysis dose (spKt/V), 14 summary comorbid conditions, and predictors listed in Table 4, and year of enrollment in DOPPS, controlling for effects of facility clustering. Open table in a new tab NOTE. To convert serum phosphorus in mg/dL to mmol/L, multiply by 0.3229; PTH in pg/mL to ng/L, multiply by 1. The DOPPS confirms and extends the state of knowledge about the adverse impact of abnormalities of mineral metabolism on the health of hemodialysis patients. The DOPPS is one of the largest observational studies to describe the state and consequences of mineral metabolism for representative samples of hemodialysis facilities and patients from 7 countries at 2 discrete time points. The current study paints an informative picture of mineral metabolism in the recent past and provides a benchmark for assessing future changes. The mineral metabolism guidelines issued by the National Kidney Foundation3K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney DiseaseAm J Kidney Dis. 2003; 42: S1-S201PubMed Google Scholar and European Best Practice Guidelines Working Group were based on evidence and expert opinion.4Kessler M. Canaud B. Pedrini L.A. et al.The EBPG Expert Group on Haemodialysis. European best practice guidelines for haemodialysis.Nephrol Dial Trans. 2002; 17: 1-111Crossref Scopus (1) Google Scholar A striking but perhaps unsurprising finding is the universal frequency with which mineral metabolism laboratory values fell outside the guideline ranges proposed by these expert panels (Tables 1 and 2). A defensible case can certainly be made for each guideline in isolation. However, our results underscore the difficulty of simultaneously achieving guideline targets for all laboratory markers (PTH, phosphorous, calcium, and calcium-phosphorous product). Management of mineral metabolism requires a complex mixture of dialysis therapy, medications, dietary intervention, patient and provider education, communication, and patient adherence. This complexity makes it difficult for providers to successfully manage mineral metabolism with the current therapeutic tools. It will be important to determine if widespread dissemination of the guidelines and new therapeutic agents will result in increased success in achieving guideline ranges for multiple mineral metabolism indicators. Several aspects of the distribution of mineral metabolism laboratory values merit particular notice. First, there appears to be a trend toward improvement over the 2- to 4-year period between DOPPS I and DOPPS II. The improvement is probably not attributable to the guidelines, which were only released during DOPPS II data collection. However, the modest improvements may be attributable to recent studies and attention on the hypothesized vascular and mortality impact of abnormal mineral metabolism. In addition, several therapies came into new or increasing use between DOPPS I and DOPPS II, including calcium-free phosphorus binder (sevelamer), several vitamin D analogs, and cinacalet HCl. Improvements were seen in some, if not all, markers of mineral metabolism for patients in all 7 of the DOPPS countries. No country patterns emerged to suggest dramatically different practices by region. Most nephrologists would not be surprised to find the serum levels of phosphorus, calcium, and calcium-phosphorus product exceeded the upper guideline limit for the majority of patients. These entities accumulate in renal failure, resulting in high blood concentrations in the absence of aggressive management. However, there may be some surprise that the overwhelming majority of patients with a PTH level outside the guideline ranges had a low concentration (Table 2). Despite the emphasis on hyperparathyroidism as a frequent and adverse feature of renal disease, hypoparathyroidism emerged as the predominant finding in the current era. Low PTH has been associated with bone disease but not with mortality risk per se. As with other DOPPS analyses and other observational studies, this study found that these easily measured laboratory indicators of mineral metabolism were significantly predictive of mortality (Table 4). All-cause and cardiovascular mortality were directly associated with higher concentrations of PTH, phosphorus, calcium, and calcium-phosphorus product (Table 4). In the current study, each indicator of mineral metabolism was analyzed as a continuous variable. In a prior categorical analysis, we found that mortality risk increased above a PTH of approximately 700 pg/mL (700 ng/L), a phosphorus of 5.5 to 6.0 mg/dL (1.78–1.94 mmol/L), and a calcium-phosphorus product of 55 to 60 mg2/dL2, all consistent with the guideline ranges. Mortality increased steadily with the calcium concentration, without an apparent plateau. Unlike earlier reports, there was no evidence of increased mortality at low calcium concentrations. However, consistent with other studies, mortality risk is higher at low concentrations of phosphorus. The higher mortality at low concentrations of serum phosphorus has been attributed to malnutrition that is not fully adjusted for in the statistical models. Management of mineral metabolism in dialysis patients is unquestionably important for maintaining musculoskeletal health. However, the repeatedly observed associations with mortality serve to solidify and magnify the importance of improving the treatment of this problem. Our findings provide an international baseline for the results of efforts to improve the management of mineral metabolism. The possibilities for improvement are substantial given the importance of mineral metabolism on survival and the recent availability of several new therapeutic agents." @default.
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• W4253293013 title "Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS)" @default.
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