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5 HIGH DOSE PARICALCITOL THERAPY USED TO DECREASE iPTH > 4000 pg/ml Susan Morrison , Cynthia Wommack, Robert Cuddihee. Affiliated Hospitals Dialysis Center, St. Louis, MO USA. Controlling iPTH and avoiding parathyroidectomy are important in managing the care of the hemodialysis patient. Patients who are compliant with their oral medications and diet may benefit from high dose paricalcitol therapy. We report a case of a 74 year old female patient with a peak iPTH of 4150. This patient had many co-morbidities and avoiding parathyroidectomy was an important consideration in her care. The patient had been on 10-14mcg paricalcitol for 9 months. The lowest iPTH attained during this time period was 1355. With much discussion it was decided to increase the dose to a maximum of 40mcg/treatment. The patient was also on Sensipar during this time period. The paricalcitol dose was increased from 25mcg to 40mcg over a 3 month period and the patient was maintained on a dose of 40mcg for 6 months. Her iPTH dropped from a maximum of 4150 to 260. At this point, the paricalcitol dose was decreased to 35mcg for 1 month, 25mcg the following month, and finally 10mcg. The patient’s iPTH dropped to 161. The patient’s calcium level remained <10.0 until the last 2 months, when it reached a level of 10.1. The patient had a maximum alkaline phosphatase of 591, which dropped to 101 during this time period. Prior to the high dose paricalcitol therapy, the patient reported breaking ribs when bending over, mid-abdominal pain and fatigue. During the time period of the high dose therapy and decreased iPTH level, her symptoms improved. She experienced improved endurance, lessened mid-abdominal pain and no bone fractures. She is very pleased with the result of this therapy. In summary, this demonstrates that high dose paricalcitol therapy may be a choice to avoid parathyroidectomy in patients who are compliant with their medications and their low phosphorus diet restrictions. 6 COMBINATION THERAPY INCLUDING SEVELAMER HCL TO CONTROL SERUM CHOLESTEROL AND TRIGLYCERIDE LEVELS. Judy Pata, Stephen Silver, Rochester General Hospital Dialysis Center Rochester, NY USA Hyperlipidemia can be difficult to control in the dialysis patient when statins are not an option. A 79 year old, non-diabetic female with stage 5 CKD, started CAPD on 6/1/04 and APD on 7/21/04. This active individual is adherent with medication and diet (3 gm Na, heart healthy, high protein, low phosphorus.) Weight for height is within normal limits and albumins are within normal. The patient had elevated total cholesterol, triglycerides, and LDL cholesterol. Four different statins had been prescribed but none were tolerated due to muscle pain. Ezetimibe was tolerated at a dose of 10 mg daily but lipid levels remained elevated. A combination of non-statin therapies was then instituted. Laboratory values (all units in mg/dl.) and medications are noted below: Date Chol TG LDL HDL P Medications 1/04 252 325 147 40 5.5 ezetimibe 10 mg/d 6/04 207 328 103 38 4.9 Addition: niacin tapering up to 1000 mg/d 11/04 248 299 136 52 4.6 1/29/04 niacin discontinued - rash 2/05 254 512 41 4.4 10/05 244 497 4.6 Addition: fish oil 2000 mg bid 1/06 273 389 133 62 5.4 3/06 5.2 Addition: sevelamer 1600 mg tid 7/06 195 271 96 45 5.9 11/06 190 305 86 43 5.6 fish oil 2000 mg bid ezetimibe 10 mg/d sevelamer 1600 mg tid With the introduction of fish oil in October 2005, the triglyceride level dropped in January 2006. The HDL cholesterol was also improved but LDL cholesterol remained elevated. Sevelamer was substituted for calcium carbonate phosphate binder in March 2006. The July and November 2006 draws demonstrated an improvement in total cholesterol, LDL and triglyceride levels compared to January. The previous improvement in the HDL levels was not sustained. In conclusion, addition of sevelamer to the patient's lipid lowering regimen may have resulted in further lowering of triglycerides as well as LDL. 7 CAN ORAL SUPPLEMENTATION WITH A COLLAGEN-CASEIN BASED HYDROLIZED LIQUID PROTEIN IMPROVE SERUM ALBUMIN LEVELS IN HYPOALBUMINEMIC HEMODIALYSIS PATIENTS? Ann Pittaoulis , Evelyn Phillips, Adriana Popovici, Mary Anne Rocks, Kelly Lynn; Philadelphia, PA, USA Decreased albumin (ALB) synthesis results in hypoalbuminemia and occurs due to the interrelationship of inflammation and malnutrition (uremic malnutrition) observed in chronic hemodialysis (CHD) patients. Improving the nutritional status of CHD patients is necessary to prevent and treat uremic malnutrition. The issue remains in how to achieve this goal in CHD patients given the barriers to adequate and appropriate intake such as anorexia, dietary restrictions and impaired nutrient absorption. The objective was to determine if oral supplementation with a collagen-casein based hydrolyzed liquid protein can improve ALB in hypoalbuminemic CHD patients. Our subjects were adult CHD outpatients with serum ALB > or =2.8 g/dL and < or =3.7 g/dL with given written consent. Subjects (age = 31-90y) were divided into 2 groups based on days of dialysis. Controls (n=21; dialysis days TThSat) received standard nutritional counseling. Study group (n=29; dialysis days MWF) received 30 ml of liquid protein one hour into and 15 minutes before the end of treatment. The main outcome measures included: Baseline and monthly ALB for 3 months and subjective assessment of adverse events. In the control group, 5 subjects did not complete the study (final n=16 [49%]) and 12 subjects in the study group, (final n=17 [51%]). There was not a statistically significant correlation between baseline ALB and baseline CRP, r= -0.30 (P=0.093) or between baseline ALB and baseline URR, r= 0.27 (P=0.14). There was no difference in the average ALB between baseline (3.43) and final (3.44 g/dL) for the control group, t= -0.54; df=15; P=0.60. In the study group, the final average (SD) ALB (3.73 [0.28]) was statistically significantly greater than baseline (3.49[0.20]), t= -4.19; df=16; P=0.001. These statistically significant results indicate that oral supplementation with a collagen-casein based hydrolyzed liquid protein can improve serum albumin levels in hypoalbuminemic CHD patients. 8 INTRADIALYTIC PARENTERAL NUTRITION (IDPN): CHANGES IN ALBUMIN, TOTAL PROTEIN, DRY WEIGHT, BUN, AND CREATININE AFTER 3 TO 12 MONTHS OF THERAPY. Deborah Scholl , Richard Dowling, Michelle Ricker, Stan Lindenfeld, Pentec Health, Inc., Boothwyn, PA, USA. An observational, retrospective study of response to IDPN was conducted in 164 maintenance hemodialysis (MHD) patients (pts) who received the therapy for 3 to 12 months over a 46 month period in 28 different dialysis units. Data was gathered from dialysis unit medical records. At the start of therapy mean age was 63.3 years with a range of 22 to 91 years, 47% male, 53% female and 52% had diabetes. All pts received amino acids (average 58.5 g/treatment) and dextrose three times a week during MHD. In addition 16% of pts received 10% lipids and 63% of pts received 20% lipids at each treatment in a 3 in 1 solution. Lipid intolerances were reported in 8 pts (5%), 5 had nausea and/or vomiting and 3 unspecified symptoms. In 9 of 164 pts (5%), IDPN was stopped because of intolerance not related to lipids. In 147 pts with complete data, mean baseline albumin (ALB) was 2.7 gm/dl (range 1.3 to 4.4) and mean final ALB was 3.1 gm/dl (range 1.3 to 4.6). Mean ALB change was +0.4 gm/dl. An improvement in ALB of at least 0.3 gm/dl was observed in 59% of pts. In 126 pts with complete data, mean baseline total protein (TP) was 6.6 gm/dl (range 4.1 to 11.0) and mean final TP was 7.1 gm/dl (range 4.6 to 11.3). An improvement in TP of greater than 0.2 gm/dl was seen in 60% of patients. Mean weight change in 138 pts with complete data was -1.5 kg (range of -20.5 to +10 kg). Fifty percent of pts lost weight, 16% maintained weight and 34% gained weight. In 146 pts with complete data, mean baseline BUN was 40 mg/dl, mean final BUN was 52 mg/dl and mean BUN change was +12 mg/dl. BUN improved by at least 20 mg/dl in 36% of pts. In 144 pts with complete data, mean baseline creatinine (CR) was 6.5 mg/dl and mean final CR was 6.6 mg/dl. In conclusion IDPN was well tolerated and resulted in positive responses in ALB, TP and BUN in the majority of pts. Epidemiological studies have shown that improvement in ALB of the magnitude seen in our study results in a marked improvement in survival and morbidity in MHD pts. IDPN appears to be an effective therapy for raising ALB levels in MHD patients with protein malnutrition. MEETING ABSTRACTS 162

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5HIGH DOSE PARICALCITOL THERAPY USED TO DECREASE iPTH > 4000 pg/ml Susan Morrison, Cynthia Wommack, Robert Cuddihee. Affiliated Hospitals Dialysis Center, St. Louis, MO USA. Controlling iPTH and avoiding parathyroidectomy are important in managing the care of the hemodialysis patient. Patients who are compliant with their oral medications and diet may benefit from high dose paricalcitol therapy. We report a case of a 74 year old female patient with a peak iPTH of 4150. This patient had many co-morbidities and avoiding parathyroidectomy was an important consideration in her care. The patient had been on 10-14mcg paricalcitol for 9 months. The lowest iPTH attained during this time period was 1355. With much discussion it was decided to increase the dose to a maximum of 40mcg/treatment. The patient was also on Sensipar during this time period. The paricalcitol dose was increased from 25mcg to 40mcg over a 3 month period and the patient was maintained on a dose of 40mcg for 6 months. Her iPTH dropped from a maximum of 4150 to 260. At this point, the paricalcitol dose was decreased to 35mcg for 1 month, 25mcg the following month, and finally 10mcg. The patient’s iPTH dropped to 161. The patient’s calcium level remained <10.0 until the last 2 months, when it reached a level of 10.1. The patient had a maximum alkaline phosphatase of 591, which dropped to 101 during this time period. Prior to the high dose paricalcitol therapy, the patient reported breaking ribs when bending over, mid-abdominal pain and fatigue. During the time period of the high dose therapy and decreased iPTH level, her symptoms improved. She experienced improved endurance, lessened mid-abdominal pain and no bone fractures. She is very pleased with the result of this therapy. In summary, this demonstrates that high dose paricalcitol therapy may be a choice to avoid parathyroidectomy in patients who are compliant with their medications and their low phosphorus diet restrictions.

6COMBINATION THERAPY INCLUDING SEVELAMER HCL TO CONTROL

SERUM CHOLESTEROL AND TRIGLYCERIDE LEVELS. Judy Pata, Stephen Silver, Rochester General Hospital Dialysis Center Rochester, NY USA Hyperlipidemia can be difficult to control in the dialysis patient when statins are not an option. A 79 year old, non-diabetic female with stage 5 CKD, started CAPD on 6/1/04 and APD on 7/21/04. This active individual is adherent with medication and diet (3 gm Na, heart healthy, high protein, low phosphorus.) Weight for height is within normal limits and albumins are within normal. The patient had elevated total cholesterol, triglycerides, and LDL cholesterol. Four different statins had been prescribed but none were tolerated due to muscle pain. Ezetimibe was tolerated at a dose of 10 mg daily but lipid levels remained elevated. A combination of non-statin therapies was then instituted. Laboratory values (all units in mg/dl.) and medications are noted below: Date Chol TG LDL HDL P Medications1/04 252 325 147 40 5.5 ezetimibe 10 mg/d 6/04 207 328 103 38 4.9 Addition: niacin tapering up to

1000 mg/d 11/04 248 299 136 52 4.6 1/29/04 niacin discontinued -

rash 2/05 254 512 41 4.410/05 244 497 4.6 Addition: fish oil 2000 mg bid 1/06 273 389 133 62 5.43/06 5.2 Addition: sevelamer 1600 mg tid 7/06 195 271 96 45 5.911/06 190 305 86 43 5.6 fish oil 2000 mg bid

ezetimibe 10 mg/d sevelamer 1600 mg tid

With the introduction of fish oil in October 2005, the triglyceride level dropped in January 2006. The HDL cholesterol was also improved but LDL cholesterol remained elevated. Sevelamer was substituted for calcium carbonate phosphate binder in March 2006. The July and November 2006 draws demonstrated an improvement in total cholesterol, LDL and triglyceride levels compared to January. The previous improvement in the HDL levels was not sustained. In conclusion, addition of sevelamer to the patient's lipid lowering regimen may have resulted in further lowering of triglycerides as well as LDL.

7CAN ORAL SUPPLEMENTATION WITH A COLLAGEN-CASEIN BASED HYDROLIZED LIQUID PROTEIN IMPROVE SERUM ALBUMIN LEVELS IN HYPOALBUMINEMIC HEMODIALYSIS PATIENTS? Ann Pittaoulis, Evelyn Phillips, Adriana Popovici, Mary Anne Rocks, Kelly Lynn; Philadelphia, PA, USA Decreased albumin (ALB) synthesis results in hypoalbuminemia and occurs due to the interrelationship of inflammation and malnutrition (uremic malnutrition) observed in chronic hemodialysis (CHD) patients. Improving the nutritional status of CHD patients is necessary to prevent and treat uremic malnutrition. The issue remains in how to achieve this goal in CHD patients given the barriers to adequate and appropriate intake such as anorexia, dietary restrictions and impaired nutrient absorption. The objective was to determine if oral supplementation with a collagen-casein based hydrolyzed liquid protein can improve ALB in hypoalbuminemic CHD patients. Our subjects were adult CHD outpatients with serum ALB > or =2.8 g/dL and < or =3.7 g/dL with given written consent. Subjects (age = 31-90y) were divided into 2 groups based on days of dialysis. Controls (n=21; dialysis days TThSat) received standard nutritional counseling. Study group (n=29; dialysis days MWF) received 30 ml of liquid protein one hour into and 15 minutes before the end of treatment. The main outcome measures included: Baseline and monthly ALB for 3 months and subjective assessment of adverse events. In the control group, 5 subjects did not complete the study (final n=16 [49%]) and 12 subjects in the study group, (final n=17 [51%]). There was not a statistically significant correlation between baseline ALB and baseline CRP, r= -0.30 (P=0.093) or between baseline ALB and baseline URR, r= 0.27 (P=0.14). There was no difference in the average ALB between baseline (3.43) and final (3.44 g/dL) for the control group, t= -0.54; df=15; P=0.60. In the study group, the final average (SD) ALB (3.73 [0.28]) was statistically significantly greater than baseline (3.49[0.20]), t= -4.19; df=16; P=0.001. These statistically significant results indicate that oral supplementation with a collagen-casein based hydrolyzed liquid protein can improve serum albumin levels in hypoalbuminemic CHD patients.

8INTRADIALYTIC PARENTERAL NUTRITION (IDPN): CHANGES IN ALBUMIN, TOTAL PROTEIN, DRY WEIGHT, BUN, AND CREATININE AFTER 3 TO 12 MONTHS OF THERAPY. Deborah Scholl, Richard Dowling, Michelle Ricker, Stan Lindenfeld, Pentec Health, Inc., Boothwyn, PA, USA. An observational, retrospective study of response to IDPN was conducted in 164 maintenance hemodialysis (MHD) patients (pts) who received the therapy for 3 to 12 months over a 46 month period in 28 different dialysis units. Data was gathered from dialysis unit medical records. At the start of therapy mean age was 63.3 years with a range of 22 to 91 years, 47% male, 53% female and 52% had diabetes. All pts received amino acids (average 58.5 g/treatment) and dextrose three times a week during MHD. In addition 16% of pts received 10% lipids and 63% of pts received 20% lipids at each treatment in a 3 in 1 solution. Lipid intolerances were reported in 8 pts (5%), 5 had nausea and/or vomiting and 3 unspecified symptoms. In 9 of 164 pts (5%), IDPN was stopped because of intolerance not related to lipids. In 147 pts with complete data, mean baseline albumin (ALB) was 2.7 gm/dl (range 1.3 to 4.4) and mean final ALB was 3.1 gm/dl (range 1.3 to 4.6). Mean ALB change was +0.4 gm/dl. An improvement in ALB of at least 0.3 gm/dl was observed in 59% of pts. In 126 pts with complete data, mean baseline total protein (TP) was 6.6 gm/dl (range 4.1 to 11.0) and mean final TP was 7.1 gm/dl (range 4.6 to 11.3). An improvement in TP of greater than 0.2 gm/dl was seen in 60% of patients. Mean weight change in 138 pts with complete data was -1.5 kg (range of -20.5 to +10 kg). Fifty percent of pts lost weight, 16% maintained weight and 34% gained weight. In 146 pts with complete data, mean baseline BUN was 40 mg/dl, mean final BUN was 52 mg/dl and mean BUN change was +12 mg/dl. BUN improved by at least 20 mg/dl in 36% of pts. In 144 pts with complete data, mean baseline creatinine (CR) was 6.5 mg/dl and mean final CR was 6.6 mg/dl. In conclusion IDPN was well tolerated and resulted in positive responses in ALB, TP and BUN in the majority of pts. Epidemiological studies have shown that improvement in ALB of the magnitude seen in our study results in a marked improvement in survival and morbidity in MHD pts. IDPN appears to be an effective therapy for raising ALB levels in MHD patients with protein malnutrition.

MEETING ABSTRACTS162