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• W1984735161 abstract "Diabetes is the most common cause of end-stage renal disease and an important risk factor for morbidity and mortality in dialysis patients. Glycemic control, utilizing serial measurement of glycosylated hemoglobin (HbA1c), is generally recommended to limit end-organ damage, including cardiovascular morbidity and mortality. We, along with others, have previously suggested that HbA1c may not be a reliable measure of glycemic control in dialysis patients, and have therefore explored the use of serum fructosamine (SF) as an alternative marker. The objective of this study was to compare HbA1c levels with SF in monitoring glycemic control and associated morbidity (infection and hospitalization) in diabetic patients in a large urban hemodialysis (HD) center. We enrolled 100 diabetic HD patients and followed them up prospectively for 3 years. Data on demographics, as well as biochemical and clinical data, including hospitalizations and infections, were recorded. The mean age was 63 years. In all 54% were women and the majority were African Americans (72%). As expected, HbA1c and albumin-corrected fructosamine (AlbF) levels were highly correlated and both were significantly associated with serum glucose. AlbF, however, was more highly correlated with mean glucose values when less than 150 mg/dl and was a more useful predictor of morbidity. By univariate logistic regression and by Poisson regression analysis, AlbF, but not HbA1c, was a significant predictor of hospitalization. Additionally, in patients dialyzed by arteriovenous (AV) access (that is, excluding those dialyzed via vascular catheters), AlbF, but not HbA1c, was a significant predictor of infection. In conclusion, AlbF is as reliable a marker as HbA1c for glycemic control in diabetic patients on HD, and may be advantageous for patients with serum glucose in a desirable therapeutic range (<150 mg/dl). In addition, AlbF, but not HbA1c, is associated with morbidity (hospitalizations and infections) in diabetic patients on HD. Diabetes is the most common cause of end-stage renal disease and an important risk factor for morbidity and mortality in dialysis patients. Glycemic control, utilizing serial measurement of glycosylated hemoglobin (HbA1c), is generally recommended to limit end-organ damage, including cardiovascular morbidity and mortality. We, along with others, have previously suggested that HbA1c may not be a reliable measure of glycemic control in dialysis patients, and have therefore explored the use of serum fructosamine (SF) as an alternative marker. The objective of this study was to compare HbA1c levels with SF in monitoring glycemic control and associated morbidity (infection and hospitalization) in diabetic patients in a large urban hemodialysis (HD) center. We enrolled 100 diabetic HD patients and followed them up prospectively for 3 years. Data on demographics, as well as biochemical and clinical data, including hospitalizations and infections, were recorded. The mean age was 63 years. In all 54% were women and the majority were African Americans (72%). As expected, HbA1c and albumin-corrected fructosamine (AlbF) levels were highly correlated and both were significantly associated with serum glucose. AlbF, however, was more highly correlated with mean glucose values when less than 150 mg/dl and was a more useful predictor of morbidity. By univariate logistic regression and by Poisson regression analysis, AlbF, but not HbA1c, was a significant predictor of hospitalization. Additionally, in patients dialyzed by arteriovenous (AV) access (that is, excluding those dialyzed via vascular catheters), AlbF, but not HbA1c, was a significant predictor of infection. In conclusion, AlbF is as reliable a marker as HbA1c for glycemic control in diabetic patients on HD, and may be advantageous for patients with serum glucose in a desirable therapeutic range (<150 mg/dl). In addition, AlbF, but not HbA1c, is associated with morbidity (hospitalizations and infections) in diabetic patients on HD. The prevalence of diabetes is increasing worldwide. According to a 2009 Centers for Disease Control report, more than 23.6 million Americans have diabetes, of whom 5.7 million do not know that they have the disease. Diabetes is the leading cause of end-stage renal disease in the United States, accounting for approximately 44% of new patients requiring dialysis.1.United States Renal Data System Excerpts from the USRDS 2008 annual data report: Atlas of end-stage renal disease in the United States.Am J Kidney Dis. 2009; 53: S129-S142PubMed Google Scholar The number of patients with diabetes as the primary cause of end-stage renal disease increased by 6.6% between 2001 and 2005.2United States Renal Data System.in: USRDS 2007 Annual Data Report, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney disease, Bethesda, MD2007Google Scholar Diabetes is a known mortality risk in hemodialysis (HD) patients.3.Oomichi T. Emoto M. Tabata T. et al.Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study.Diabetes Care. 2006; 29: 1496-1500Crossref PubMed Scopus (149) Google Scholar Glycemic control can limit end organ damage, cardiovascular morbidity, and mortality in these patients.4.McMurray S.D. Johnson G. Davis S. et al.Diabetes education and care management significantly improve patient outcomes in the dialysis unit.Am J Kidney Dis. 2002; 40: 566-575Abstract Full Text Full Text PDF PubMed Scopus (156) Traditionally, serial measurements of blood glucose and glycosylated hemoglobin (HbA1c), which reflect the previous 2–3 months of glycemic control, have been used to monitor glycemic control in diabetic HD patients, as for diabetics in the general population. Although graded glycohemoglobin levels within the normal range have been associated with coronary artery disease in nondiabetics without renal disease,5.Selvin E. Coresh J. Golden S.H. et al.Glycemic control and coronary heart disease risk in persons with and without diabetes. The atherosclerosis risk in communities study.Arch Intern Med. 2005; 165: 1910-1916Crossref PubMed Scopus (232) Google Scholar and blood glucose level is a risk factor for cardiovascular disease in healthy individuals without diabetes,6.Levitan E.B. Song Y. Ford E.S. et al.Is nondiabetic hyperglycemia a risk factor for cardiovascular disease?.Arch Intern Med. 2004; 164: 2147-2155Crossref PubMed Scopus (542) Google Scholar little information is available in the dialysis population. Kalantar-Zadeh et al.,7.Kalantar-Zadeh K. Kopple J.D. Regidor D.L. et al.A1C and survival in maintenance hemodialysis patients.Diabetes Care. 2007; 30: 1049-1055Crossref PubMed Scopus (202) Google Scholar using a large dialysis provider's database, noted paradoxically better survival with a poorer glycemic index (that is, lower mortality hazard ratios with higher A1c values). However, HbA1c may not be an ideal measure of glycemic control in diabetic end-stage renal disease patients, as it may be lowered by shortened red cell survival or by increased red cell turnover due to repetitive proerythropoietic stimulation (for example, recombinant human erythropoietin), or affected by assay interference from uremia. Several alternative indices of glycemic control have been reported in literature, including serum fructosamine (SF), which has a shorter half-life than HbA1c.8.Coronel F. Marcia M. Ciodoncha A. et al.Fructosamine levels in CAPD: its value as glycemic index.Adv Perit Dial. 1991; 7: 253-256PubMed Google Scholar, 9.Inaba M. Okuno S. Kumeda Y. et al.Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection.J Am Soc Nephrol. 2007; 18: 896-903Crossref PubMed Scopus (406) Google Scholar, 10.Peacock T.P. Shihabi Z.K. Bleyer A.J. et al.Comparison of glycated albumin and hemoglobin A(1c) levels in diabetic subjects on hemodialysis.Kidney Int. 2008; 7: 1062-1068Abstract Full Text Full Text PDF Scopus (262) Google Scholar SF, produced by the spontaneous, nonenzymatic glycation of proteins, reflects very recent (1–3 weeks) glycemic control, potentially lessening the confounding effect of shortened red cell survival or of high red cell turnover seen with A1c (HbA1c) levels. Few reports in literature have assessed the validity of alternative indices of glycemic control in dialysis patients. Those published have involved small numbers of patients, and results have been contradictory.8.Coronel F. Marcia M. Ciodoncha A. et al.Fructosamine levels in CAPD: its value as glycemic index.Adv Perit Dial. 1991; 7: 253-256PubMed Google Scholar, 11.Ichikawa H. Nagake Y. Takahashi M. et al.What is the best index of glycemic control in patients with diabetes on hemodialysis?.Nippon Jinzo Gakkai shi. 1996; 38: 305-308PubMed Google Scholar, 12.Nunoi K. Kodama T. Sato Y. et al.Comparison of reliability of plasma fructosamine and glycosylated hemoglobin assays for assessing glycemic control in diabetic patients on hemodialysis.Metabolism. 1991; 40: 986-989Abstract Full Text PDF PubMed Scopus (14) Google Scholar Elevated SF levels have been associated with increased cardiovascular mortality in nonuremic nondiabetics,13.Browner W.S. Pressman A.R. Lui L.-Y. et al.The association between serum fructosamine and mortality in elderly women. The study of osteoporotic fractures.Am J Epidemiol. 1999; 149: 471-475Crossref PubMed Scopus (27) Google Scholar but little information is available with regard to the association of SF with morbidity in HD patients. The demographics of the patient population are shown in Table 1. The mean age was 63 years. Women comprised 54%, and the majority were African Americans (72%). Mean dialysis vintage was 36 months. Mean values for SF, albumin-corrected fructosamine (AlbF), and HbA1c (A1c) were 373 μmol/l (range: 243–618 μmol/l), 973 μmol/g (range: 607–1994 μmol/g), and 7.2% (range: 5–14%), respectively. As expected, HbA1c and fructosamine levels were highly correlated. Enrollment and follow-up A1c values strongly and positively correlated with the corresponding SF values (r=0.66, P<0.0001 at enrollment, and r=0.75, P<0.0001 at follow-up) and AlbF values (r=0.67, P<0.0001 at enrollment, and r=0.74, P<0.0001 at follow-up). Both measures of glycemic index, A1c and SF, were highly correlated with glucose measurements, with similar correlation coefficients and levels of significance (r=0.70, P<0.0001 versus r=0.63, P=<0.0001 for enrollment AlbF and A1c, respectively; and r=0.75, P<0.0001 versus r=0.71, P<0.0001 for follow-up AlbF and A1c, respectively). AlbF was much more highly correlated with mean glucose values when glucose values were less than 150 mg/dl (r=0.57, P=0.001 versus r=0.31, P=0.19 for enrollment AlbF and A1c, respectively; and r=0.55, P=0.001 versus r=0.45, P=0.01 for follow-up AlbF and A1c, respectively) (Figures 1 and 2).Table 1Characteristics of hemodialysis patientsAge (years, mean±s.d.)63±11 (range 35–85)Gender, female (%)54Race African Americans (%)72 White (%)5 Hispanic (%)21 Other (%)2Months on dialysis at enrollment (mean±s.d.)36±44 (range 0.1–296) Open table in a new tab Figure 2Correlation of fructosamine and glycosylated hemoglobin with serum glucose. Relationship between glucose and (a) follow-up albumin-corrected fructosamine (correlation coefficient r=0.55, P=0.001) and (b) follow-up glycosylated hemoglobin (HbA1c, correlation coefficient r=0.45, P=0.01) in diabetic hemodialysis patients with glucose level less than 150 mg/dl.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Table 2 compares the levels of AlbF and HbA1c by hospitalizations and by infection. Patients who were hospitalized during the study period had higher AlbF levels compared with those who were not hospitalized (974 versus 863 μmol/g, P=0.012), whereas there was no significant difference in A1c between the groups (P=0.96). Similarly, patients dialyzed using AV access (that is, excluding those using catheters) and having an infection during the study period had significantly higher AlbF (998 versus 903 μmol/g, P=0.03). By univariate logistic regression analysis, AlbF was a significant positive predictor of hospitalization (odds ratio=1.005, P=0.016) and of infection (odds ratio=1.003, P=0.039) in diabetic HD patients, whereas A1c did not predict hospitalization (odds ratio=1.01, P=0.96) or infection (odds ratio=1.34, P=0.17). By Poisson regression analysis, AlbF was a significant predictor of the number of hospitalizations per patient year (relative risk=1.12, P=0.007), the duration of hospitalization per patient year (relative risk=1.19, P<0.0001), and the number of episodes of infection per patient year (relative risk=1.29, P=0.001), whereas A1c did not predict frequency or duration of hospitalization or of infection in patients receiving dialysis by AV access (Table 3).Table 2Fructosamine and HbA1c by hospitalization and infection in diabetic hemodialysis patientsHospitalizationInfectionYesNoP-valueYesNoP-valueHbA1c (%)7.02±1.27.01±1.30.967.31±1.366.86±1.190.17Albumin-corrected fructosamine (μmol/g)974±158863±1690.012998±194903±1470.03Abbreviation: HbA1c, glycosylated hemoglobin. Open table in a new tab Table 3Poisson regression analysis: predictors of hospitalization and infection in hemodialysis patientsHbA1c (%)Albumin-corrected fructosamine (μmol/g)aValues of fructosamine were divided by 100 for scaling purposes.OutcomeRR (95% CI)P-valueRR (95% CI)P-valueFrequency of hospitalization1.02 (0.36, 1.86)0.761.12 (1.03, 1.22)0.007Duration of hospitalization0.97 (0.93, 1.00)0.121.19 (1.15, 1.22)<0.001Infections1.22 (0.86, 1.72)0.271.29 (1.11, 1.51)0.001Abbreviations: CI, confidence interval; HbA1c, glycosylated hemoglobin; RR, relative ratio.a Values of fructosamine were divided by 100 for scaling purposes. Open table in a new tab Abbreviation: HbA1c, glycosylated hemoglobin. Abbreviations: CI, confidence interval; HbA1c, glycosylated hemoglobin; RR, relative ratio. This study has shown that two indices of glycemic control, HbA1c and SF, correlate with each other and with mean blood glucose levels in our diabetic HD population. Whereas AlbF and A1c equally reflected mean blood glucose values or glycemic status in the entire population, we found that when serum glucose was stratified for ‘acceptable’ glycemic control (mean serum glucose below 150 mg/dl), AlbF was more highly correlated with mean glucose than was A1c. This supports the hypothesis that A1c may not be the best measure of glycemic control in diabetic HD patients, as it may be affected by shortened red cell survival, by increased red cell turnover due to repetitive proerythropoietic stimulation (that is, recombinant human erythropoietin), or by assay interference from uremia.11.Ichikawa H. Nagake Y. Takahashi M. et al.What is the best index of glycemic control in patients with diabetes on hemodialysis?.Nippon Jinzo Gakkai shi. 1996; 38: 305-308PubMed Google Scholar, 14.Nakao T. Matsumoto H. Okada T. et al.Influence of erythropoietin treatment on hemoglobin A1c levels in patients with chronic renal failure on hemodialysis.Intern Med. 1998; 37: 826-830Crossref PubMed Scopus (114) Google Scholar Our findings are consistent with those of Shoji et al.,15.Shoji T. Tabata T. Nishizawa Y. et al.Clinical availability of serum fructosamine measurement in diabetic patients with uremia. Use as a glycemic index in uremic diabetes.Nephron. 1989; 51: 338-343Crossref PubMed Google Scholar who reported that SF level corrected for protein concentration is an excellent glycemic index in diabetic patients with CKD, and is not affected by urea, which is known to influence the level of HbA1c. Lamb et al.16.Lamb E. Venton T.R. Cattell W.R. et al.Serum glycated albumin and fructosamine in renal dialysis patients.Nephron. 1993; 64: 82-88Crossref PubMed Scopus (29) Google Scholar reported that SF is elevated in HD patients, but suggested that, when corrected for total protein concentration, it is probably a more reliable marker of glycemic index than glycated hemoglobin. Coronel et al.8.Coronel F. Marcia M. Ciodoncha A. et al.Fructosamine levels in CAPD: its value as glycemic index.Adv Perit Dial. 1991; 7: 253-256PubMed Google Scholar studied glycemic control in diabetic continuous ambulatory peritoneal dialysis patients, reporting that there were good correlations between fructosamine and mean blood glucose over the preceding 3 weeks, and concluded that both assays can be used as glycemic indices. Some authors have suggested other glycemic indices as superior alternatives to A1c. Recently, Inaba et al.9.Inaba M. Okuno S. Kumeda Y. et al.Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection.J Am Soc Nephrol. 2007; 18: 896-903Crossref PubMed Scopus (406) Google Scholar reported that glycated albumin is a better glycemic indicator than are glycated hemoglobin values in HD patients with diabetes, whereas Peacock et al.10.Peacock T.P. Shihabi Z.K. Bleyer A.J. et al.Comparison of glycated albumin and hemoglobin A(1c) levels in diabetic subjects on hemodialysis.Kidney Int. 2008; 7: 1062-1068Abstract Full Text Full Text PDF Scopus (262) Google Scholar suggested that in diabetic HD patients, HbA1c levels significantly underestimate glycemic control, whereas those of glycated albumin more accurately reflect this control. On the other hand, Ichikawa et al.11.Ichikawa H. Nagake Y. Takahashi M. et al.What is the best index of glycemic control in patients with diabetes on hemodialysis?.Nippon Jinzo Gakkai shi. 1996; 38: 305-308PubMed Google Scholar evaluated multiple indices of glycemic control in diabetic HD patients, including HbA1c, fructosamine, glycated albumin, and 1,5-anhydroglucitol, concluding that HbA1c was the most reliable index. Similarly, Nunoi et al.12.Nunoi K. Kodama T. Sato Y. et al.Comparison of reliability of plasma fructosamine and glycosylated hemoglobin assays for assessing glycemic control in diabetic patients on hemodialysis.Metabolism. 1991; 40: 986-989Abstract Full Text PDF PubMed Scopus (14) Google Scholar and Joy et al.17.Joy M.S. Cefalu W.T. Hogan S.L. et al.Long-term glycemic control measurements in diabetic patients receiving hemodialysis.Am J Kidney Dis. 2002; 39: 297-307Abstract Full Text Full Text PDF PubMed Scopus (128) Google Scholar reported that, in HD patients, fructosamine correlated poorly with blood glucose, and that HbA1c was a superior marker of glycemic control. We have examined the association of morbidity, that is, hospitalization and infection, with two glycemic markers, HbA1c and AlbF, in our diabetic HD patients. It should be noted that we used mean serum glucose values over a longer period than did other studies cited above (3–4 months as opposed to 2–4 weeks), a time period that should have more fairly leveled the comparison. As central venous catheter hemoaccess was so strongly associated with the incidence of infection (odds ratio=11, P=0.026, by logistic regression analysis) compared with AV access, we analyzed data in patients dialyzed with AV access only. In our diabetic HD patients, hospitalization and risk of infection were associated with increased levels of AlbF, but not with the current standard of diabetic care, namely, hemoglobin A1c. A reasonable inference can be made that higher levels of AlbF reflect poorer glycemic control, potentially resulting in more diabetic complications and, therefore, in more hospitalizations and infections. Increased nonenzymatic glycosylation of various proteins such as glycosylated hemoglobin, glycated albumin, and fructosamine has been reported to be associated with diabetic complications. In addition, increased levels of glycated proteins have been reported to diminish immune function,18.Cohen G. Rudnicki M. Walter F. et al.Glucose-modified proteins modulate essential functions and apoptosis of polymorphonuclear leukocytes.J Am Soc Nephrol. 2001; 12: 1264-1271PubMed Google Scholar increase oxidative stress, proinflammatory response,19.Aronson D. Hyperglycemia and the pathobiology of diabetic complications.Adv Cardiol. 2008; 45: 1-16Crossref PubMed Scopus (273) Google Scholar and induce various other pathological events. In nonuremic diabetic patients, good preoperative glycemic control (HbA1c level <7.0%) is associated with a decrease in infectious complications across a variety of surgical procedures.20.Dronge A.S. Perkal M.F. Kancir S. et al.Long-term glycemic control and postoperative infectious complications.Arch Surg. 2006; 141: 375-380Crossref PubMed Scopus (245) Google Scholar SF is increased in anemic Helicobacter pylori-infected nondiabetic nonuremic patients compared with healthy controls.21.Vijayan G. Sundaram R.C. Bobby Z. et al.Increased plasma malondialdehyde and fructosamine in anemic H. pylori infected patients: effect of treatment.World J Gastroenterol. 2007; 13: 796-800Crossref PubMed Scopus (20) Google Scholar Published information regarding the relationship of A1c and AlbF with morbidity, hospitalization, and infection in diabetic HD patients is scarce. In a retrospective study, extremely high and low HbA1c values were associated with hospitalization risk in diabetic HD patients.22.Williams M.E. Lacson Jr, E. Teng M. et al.Extremes of glycemic control (HbA1c) increase hospitalization risk in diabetic hemodialysis patients in the USA.Am J Nephrol. 2009; 29: 54-61Crossref PubMed Scopus (21) Google Scholar Glycated albumin, but not glycated hemoglobin, was associated with peripheral vascular calcification in diabetic HD patients.23.Yamada S. Inaba M. Shidara K. et al.Association of glycated albumin, but not glycated hemoglobin, with peripheral vascular calcification in hemodialysis patients with type 2 diabetes.Life Sci. 2008; 83: 516-519Crossref PubMed Scopus (39) Google Scholar As SF levels are directly affected by serum albumin concentration,24.Van Dieijen-Visser M.P. Seynaeve C. Brombacher P.J. Influence of variations in albumin or total-protein concentration on serum fructosamine concentration.Clin Chem. 1986; 32: 1610PubMed Google Scholar fructosamine values were corrected for serum albumin. Therefore, we examined whether serum albumin concentration itself was associated with hospitalization and infection. By logistic regression analysis, serum albumin concentration was associated with infection (odds ratio=0.19, P=0.04) but not with hospitalization (odds ratio=0.22, P=0.06); therefore, serum albumin itself may have been a contributory factor in predicting infection in our HD patients. In summary, SF, corrected for the level of serum albumin, seems to be a reliable index of glycemic control in diabetic patients on HD, and may be superior to HbA1c in some patients, especially those with ‘acceptable’ diabetic control. This study also suggests that enrollment AlbF, an alternative index of glycemia control, was more strongly associated with hospitalization and infection than was HbA1c in diabetic HD patients followed up prospectively in a single center. Large, prospective trials are needed to confirm these findings, to define optimal diabetic control in this population at great risk for cardiovascular morbidity and mortality, and to define the contribution of serum albumin to morbidity associated with SF. One hundred diabetic HD patients treated at the Avram Center for Kidney Diseases in Long Island College Hospital were enrolled in this study, conducted from February 2005 through to August 2005. Patients were followed up to April 2008. On enrollment, demographics, and clinical and biochemical data were recorded. Morbidity data including number of hospitalizations, duration of hospitalization, and episodes of infections were recorded throughout the study period. Results of monthly evaluation of biochemical parameters, including serum albumin, total protein, serum creatinine, and serum glucose, were recorded. Serial blood glucose values measured using test strips (Precision Extra, Medisense, Abbott Laboratories, Alameda, CA, USA) and predialysis serum glucose measurements for the preceeding 4-monthly chemistry panels were collected. HbA1c levels were measured by an immunoturbidimetric method. SF levels were measured by a colorimetric method (COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN, USA). Both HbA1c and fructosamine were measured at enrollment and then 6 months after enrollment. Fructosamine values were corrected for variations in the concentration of serum albumin according to the following formula by Lamb et al.16.Lamb E. Venton T.R. Cattell W.R. et al.Serum glycated albumin and fructosamine in renal dialysis patients.Nephron. 1993; 64: 82-88Crossref PubMed Scopus (29) Google ScholarAlbF=(fructosamine(μmol/l)×100/albumin(g/l)). The study protocol was approved by the Institutional Review Board of Long Island College Hospital, and informed consent was obtained from all patients. Continuous variables were expressed as mean±s.d. Correlations were reported as either the Pearson correlation coefficient or the Spearman rank correlation coefficient. Poisson regression analysis was used to examine the association of HbA1c and AlbF with hospitalization and infection. Two-sided P-values of less than 0.05 were considered as statistically significant. Calculations were performed using SPSS for Windows 12.0.1 (SPSS, Chicago, IL, USA) and SAS, version 8.2 software (SAS Institute, Carey, NC, USA). This work was supported, in part, by the Nephrology Foundation of Brooklyn. We acknowledge with gratitude the assistance and counsel provided by Dr J Michael Lazarus, Chief Medical Officer of Fresenius of North America." @default.
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• W1984735161 title "Serum fructosamine versus glycosylated hemoglobin as an index of glycemic control, hospitalization, and infection in diabetic hemodialysis patients" @default.
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