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Improved Phosphorous Control in Patients Switched to Lanthanum Carbonate from Other Binders
MEETING ABSTRACTS
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DECLINE IN SGA SCORE, HOSPITALIZATION, & DEATH IN NEW START HEMODIALYSIS PATIENTS
IMPROVED PHOSPHOROUS CONTROL IN PATIENTS SWITCHED TO LANTHANUM CARBONATE FROM OTHER BINDERS
Amy Myrtue-Nelson, Fresenius Medical Care, Olympia, WA Barbara Bruemmer and Louise Peck, University of Washington, Seattle, WA
Linda Noto, Western New York Dialysis Center, LLC, Orchard Park, NY, USA
Subjective Global Assessment (SGA) was used to evaluate nutritional status in hemodialysis (HD) patients. The aim of the this study was to determine if a one point or greater decline in SGA score between initial and 6 month assessment was predictive of the number of days new start HD patients are hospitalized in the first year. All subjects were new start HD patients entering care in 2005 in one of 14 Fresenius outpatient HD facilities located in Alaska, Oregon, and Washington. There were 180 patients who met the inclusion criteria. Initial and 6 month SGA scores, sex, height, weight, age, and type of vascular dialysis access were recorded from the electronic patient medical record. Hospitalization and mortality data was collected. The effect of decline in SGA score on number of days a patient was hospitalized was assessed using linear regression. There were 75 hospitalizations, 31 deaths, 23 (13%) patients with a decline in SGA score, and 32 patients with a 10% or greater decline in BMI between initial and 6 month assessments. Seventy patients (39%) had no change in SGA score and 85 (47%) had an increase in SGA score. Decline in SGA score was positively associated with number of days a patient is hospitalized with a linear regression coefficient of 4.3 (p 5 0.08). A crude logistic regression model was used to determine if a 1 point or greater decline in SGA was related to hospitalization as a categorical variable. The odds ratio for patients with a 1 point or greater decline in SGA score was 2.6 (95% CI 1.07-6.30). A logisticregression model was done to determine the relationship of a 1-point or greater decline in SGA score versus a stable score or increase in scoreon mortality. The adjusted odds ratio of the association was 3.67 (95% CI 1.43-9.37). A decrease in SGA score from initial assessment to 6 month assessment is related to higher odds of hospitalization in new start HD patients and higher odds of mortality between months 6 to 12. A decline in SGA score between the initial and 6 month assessment has some ability to predict the outcomes of hospitalization and mortality in new start HD patients.
The goal of this retrospective database analysis was to determine if dialysis patients in whom current phosphorous (P) binders were ineffective or intolerable benefited from switching to the non-calcium, non-resin P binder lanthanum carbonate (LC) (FosrenolÒ, Shire). Seventeen of over 100 patients on dialysis were switched from other P binders (calcium acetate [PhosLoÒ], n58; sevelamer hydrochloride [RenagelÒ], n57; calcium carbonate [TumsÒ], n52) to LC 500 or 1000 mg TID and remained on LC for at least 1 year (11 months to date in 1 patient). Serum P levels were assessed monthly and averaged over the 3-month period before the switch (1 patient was switched after only 1 month on sevelamer) and then over months 1–3, 4–6 and 10–12 after the switch (1 year after the switch); 3-month averages were used to account for month-to-month variability in P levels. Patient education and counseling programs in place before the switch were continued, with specific information about LC provided at the time of the switch. The mean (SD) of all 3-month average serum P levels in the reference period before the switch to LC was 6.4 (1.35) mg/dL. The mean over months 1–3 after the switch was 5.5 (1.36) mg/dL (P 5 0.01); at months 4–6 after the switch, 5.5 (1.06) mg/dL (P 5 0.003); at months 10–12 after the switch, 5.2 (0.87) mg/dL (19% mean improvement after 1 year on LC; P,0.004). Among the 14 patients who were above the KDOQI guideline (# 5.5 mg/dL) before the switch, 6 were within the guideline at months 1–3 after the switch and 9 were within the guideline at months 10–12 after the switch; among 3 patients switched to LC for reasons relating to tolerability, compliance, or rising calcium levels with the previous binder, 2 remained within the guideline after the switch. Thus, the overall proportion of patients with P levels within the KDOQI guideline rose from 3/17 (18%) before the switch to LC to 11/17 (65%) by 1 year after the switch. These exploratory findings suggest that LC is a rational choice for switching dialysis patients in whom other phosphorous binders were ineffective or poorly tolerated.
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EXERCISE TYPE AND MORTALITY RISK IN MODERATE CHRONIC KIDNEY DISEASE (CKD): NHANES III
RAPID AND SUSTAINED REDUCTION OF PHOSPHOROUS LEVELS WITH LANTHANUM CARBONATE TREATMENT IN PHOSPHOROUS BINDER-NAIVE PATIENTS
J Neilson, B Baird, J Zitterkoph, T Greene, and S Beddhu The survival benefits of physical activity type (aerobic exercise only or the combination of aerobic with resistance exercise) in moderate CKD are unknown. We examined the associations of type of exercise with mortality in non-CKD and CKD (MDRD GFR , 60 ml/min/1.73m2) cohorts in the National Health and Nutrition Examination survey (NHANES) III. A physical activity questionnaire was used to collect data on the frequency of walking a mile without stopping, running or jogging, riding a bicycle or exercise bike, swimming, aerobics, dancing, calisthenics, garden or yard work, lifting weights or other activities. Resistance exercise was defined as weight lifting or performing calisthenics. Participants were divided into three physical activity groups (No exercise, aerobic only and combination of aerobic and resistance). Of the 20,050 NHANES participants, a sub-population of 15,926 with nonmissing data was examined. 1127 had CKD. The associations of physical activity type with mortality was examined in multivariate Cox models adjusted for age, gender, race, cardiovascular disease, metabolic syndrome, systolic and diastolic blood pressures, GFR, proteinuria and frequency of physical activity in nonCKD and CKD populations (Table 1). Stata 10.0 (Stata Inc, College Station, TX) was used to analyze the data. Table 1. Physical activity type and mortality Non-CKD CKD Hazard Ratio (95% CI) Hazard Ratio (95% CI) No Exercise Aerobic Only Combination
Reference .63 (.46-.85) .45 (.30-.68)
Reference .59 (.44-.80) .46 (.28-.74)
Aerobic exercise only group was associated with lower mortality but the combination group had the lowest mortality in both CKD and non- CKD populations. Patients with CKD should be encouraged to perform a combination of aerobic and resistance activities.
Linda Noto, Western New York Dialysis Center, LLC, Orchard Park, New York, USA The goal of this retrospective database analysis was to determine the efficacy of the non-calcium, non-resin phosphorous (P) binder lanthanum carbonate (LC) (FosrenolÒ, Shire) in controlling serum P levels of patients on dialysis previously untreated with P binders. Patients with elevated serum P levels undergoing dialysis received education on P control and were treated with LC 500 mg TID (n 5 16) and maintained at that level (n59) or titrated to LC 1000 mg TID, as needed. Serum P levels were measured monthly. Patients began treatment for 1 year (mean [SD]: 12.00 [7.29] mo; range 2–26 mo) after (n 5 11), or before (n 5 5), starting dialysis. The mean (SD) serum P level in patients (n 5 11) before initiation of P binder treatment (6.52 [0.70] mg/dL) dropped significantly to 4.81 (1.20; P,0.001) mg/dL 1 month after start of LC 500 mg TID. For patients whose dosage was elevated to LC 1000 mg TID (n 5 6), the serum P level before dosage increase (6.93 [0.25] mg/dL) dropped significantly to 4.47 (0.95; P , 0.001) mg/dL 1 month after dosage increase. Initiation of LC treatment permitted our clinic to maintain at least 65% of the patients within the KDOQI guideline of #5.5 mg/dL. Of the 11 patients who began treatment with LC after the start of dialysis, 9 (82%) reached this level within 1 month and maintained control after 6 months. All 5 patients who began treatment with LC before dialysis met the guideline 1 month after starting dialysis and 4 (80%) maintained control after 6 months. Overall, treatment with LC was effective in bringing serum P levels within KDOQI guidelines rapidly and maintaining those levels in 13 of 16 patients (81.3%). Patient nutritional status was maintained throughout treatment (mean serum albumin levels [SD] 3.61 [0.28] g/dL over 13.81 [8.4] mo). Treatment with LC in conjunction with patient education was shown to be effective in maintaining serum P levels in patients previously untreated with P binders before starting dialysis and as primary treatment after starting dialysis.
191
5
7
DECLINE IN SGA SCORE, HOSPITALIZATION, & DEATH IN NEW START HEMODIALYSIS PATIENTS
IMPROVED PHOSPHOROUS CONTROL IN PATIENTS SWITCHED TO LANTHANUM CARBONATE FROM OTHER BINDERS
Amy Myrtue-Nelson, Fresenius Medical Care, Olympia, WA Barbara Bruemmer and Louise Peck, University of Washington, Seattle, WA
Linda Noto, Western New York Dialysis Center, LLC, Orchard Park, NY, USA
Subjective Global Assessment (SGA) was used to evaluate nutritional status in hemodialysis (HD) patients. The aim of the this study was to determine if a one point or greater decline in SGA score between initial and 6 month assessment was predictive of the number of days new start HD patients are hospitalized in the first year. All subjects were new start HD patients entering care in 2005 in one of 14 Fresenius outpatient HD facilities located in Alaska, Oregon, and Washington. There were 180 patients who met the inclusion criteria. Initial and 6 month SGA scores, sex, height, weight, age, and type of vascular dialysis access were recorded from the electronic patient medical record. Hospitalization and mortality data was collected. The effect of decline in SGA score on number of days a patient was hospitalized was assessed using linear regression. There were 75 hospitalizations, 31 deaths, 23 (13%) patients with a decline in SGA score, and 32 patients with a 10% or greater decline in BMI between initial and 6 month assessments. Seventy patients (39%) had no change in SGA score and 85 (47%) had an increase in SGA score. Decline in SGA score was positively associated with number of days a patient is hospitalized with a linear regression coefficient of 4.3 (p 5 0.08). A crude logistic regression model was used to determine if a 1 point or greater decline in SGA was related to hospitalization as a categorical variable. The odds ratio for patients with a 1 point or greater decline in SGA score was 2.6 (95% CI 1.07-6.30). A logisticregression model was done to determine the relationship of a 1-point or greater decline in SGA score versus a stable score or increase in scoreon mortality. The adjusted odds ratio of the association was 3.67 (95% CI 1.43-9.37). A decrease in SGA score from initial assessment to 6 month assessment is related to higher odds of hospitalization in new start HD patients and higher odds of mortality between months 6 to 12. A decline in SGA score between the initial and 6 month assessment has some ability to predict the outcomes of hospitalization and mortality in new start HD patients.
The goal of this retrospective database analysis was to determine if dialysis patients in whom current phosphorous (P) binders were ineffective or intolerable benefited from switching to the non-calcium, non-resin P binder lanthanum carbonate (LC) (FosrenolÒ, Shire). Seventeen of over 100 patients on dialysis were switched from other P binders (calcium acetate [PhosLoÒ], n58; sevelamer hydrochloride [RenagelÒ], n57; calcium carbonate [TumsÒ], n52) to LC 500 or 1000 mg TID and remained on LC for at least 1 year (11 months to date in 1 patient). Serum P levels were assessed monthly and averaged over the 3-month period before the switch (1 patient was switched after only 1 month on sevelamer) and then over months 1–3, 4–6 and 10–12 after the switch (1 year after the switch); 3-month averages were used to account for month-to-month variability in P levels. Patient education and counseling programs in place before the switch were continued, with specific information about LC provided at the time of the switch. The mean (SD) of all 3-month average serum P levels in the reference period before the switch to LC was 6.4 (1.35) mg/dL. The mean over months 1–3 after the switch was 5.5 (1.36) mg/dL (P 5 0.01); at months 4–6 after the switch, 5.5 (1.06) mg/dL (P 5 0.003); at months 10–12 after the switch, 5.2 (0.87) mg/dL (19% mean improvement after 1 year on LC; P,0.004). Among the 14 patients who were above the KDOQI guideline (# 5.5 mg/dL) before the switch, 6 were within the guideline at months 1–3 after the switch and 9 were within the guideline at months 10–12 after the switch; among 3 patients switched to LC for reasons relating to tolerability, compliance, or rising calcium levels with the previous binder, 2 remained within the guideline after the switch. Thus, the overall proportion of patients with P levels within the KDOQI guideline rose from 3/17 (18%) before the switch to LC to 11/17 (65%) by 1 year after the switch. These exploratory findings suggest that LC is a rational choice for switching dialysis patients in whom other phosphorous binders were ineffective or poorly tolerated.
6
8
EXERCISE TYPE AND MORTALITY RISK IN MODERATE CHRONIC KIDNEY DISEASE (CKD): NHANES III
RAPID AND SUSTAINED REDUCTION OF PHOSPHOROUS LEVELS WITH LANTHANUM CARBONATE TREATMENT IN PHOSPHOROUS BINDER-NAIVE PATIENTS
J Neilson, B Baird, J Zitterkoph, T Greene, and S Beddhu The survival benefits of physical activity type (aerobic exercise only or the combination of aerobic with resistance exercise) in moderate CKD are unknown. We examined the associations of type of exercise with mortality in non-CKD and CKD (MDRD GFR , 60 ml/min/1.73m2) cohorts in the National Health and Nutrition Examination survey (NHANES) III. A physical activity questionnaire was used to collect data on the frequency of walking a mile without stopping, running or jogging, riding a bicycle or exercise bike, swimming, aerobics, dancing, calisthenics, garden or yard work, lifting weights or other activities. Resistance exercise was defined as weight lifting or performing calisthenics. Participants were divided into three physical activity groups (No exercise, aerobic only and combination of aerobic and resistance). Of the 20,050 NHANES participants, a sub-population of 15,926 with nonmissing data was examined. 1127 had CKD. The associations of physical activity type with mortality was examined in multivariate Cox models adjusted for age, gender, race, cardiovascular disease, metabolic syndrome, systolic and diastolic blood pressures, GFR, proteinuria and frequency of physical activity in nonCKD and CKD populations (Table 1). Stata 10.0 (Stata Inc, College Station, TX) was used to analyze the data. Table 1. Physical activity type and mortality Non-CKD CKD Hazard Ratio (95% CI) Hazard Ratio (95% CI) No Exercise Aerobic Only Combination
Reference .63 (.46-.85) .45 (.30-.68)
Reference .59 (.44-.80) .46 (.28-.74)
Aerobic exercise only group was associated with lower mortality but the combination group had the lowest mortality in both CKD and non- CKD populations. Patients with CKD should be encouraged to perform a combination of aerobic and resistance activities.
Linda Noto, Western New York Dialysis Center, LLC, Orchard Park, New York, USA The goal of this retrospective database analysis was to determine the efficacy of the non-calcium, non-resin phosphorous (P) binder lanthanum carbonate (LC) (FosrenolÒ, Shire) in controlling serum P levels of patients on dialysis previously untreated with P binders. Patients with elevated serum P levels undergoing dialysis received education on P control and were treated with LC 500 mg TID (n 5 16) and maintained at that level (n59) or titrated to LC 1000 mg TID, as needed. Serum P levels were measured monthly. Patients began treatment for 1 year (mean [SD]: 12.00 [7.29] mo; range 2–26 mo) after (n 5 11), or before (n 5 5), starting dialysis. The mean (SD) serum P level in patients (n 5 11) before initiation of P binder treatment (6.52 [0.70] mg/dL) dropped significantly to 4.81 (1.20; P,0.001) mg/dL 1 month after start of LC 500 mg TID. For patients whose dosage was elevated to LC 1000 mg TID (n 5 6), the serum P level before dosage increase (6.93 [0.25] mg/dL) dropped significantly to 4.47 (0.95; P , 0.001) mg/dL 1 month after dosage increase. Initiation of LC treatment permitted our clinic to maintain at least 65% of the patients within the KDOQI guideline of #5.5 mg/dL. Of the 11 patients who began treatment with LC after the start of dialysis, 9 (82%) reached this level within 1 month and maintained control after 6 months. All 5 patients who began treatment with LC before dialysis met the guideline 1 month after starting dialysis and 4 (80%) maintained control after 6 months. Overall, treatment with LC was effective in bringing serum P levels within KDOQI guidelines rapidly and maintaining those levels in 13 of 16 patients (81.3%). Patient nutritional status was maintained throughout treatment (mean serum albumin levels [SD] 3.61 [0.28] g/dL over 13.81 [8.4] mo). Treatment with LC in conjunction with patient education was shown to be effective in maintaining serum P levels in patients previously untreated with P binders before starting dialysis and as primary treatment after starting dialysis.