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A multicenter study of the safety of intravenous iron dextran (IVFe) in hemodialysis patients
A6
1996
SPRING
CLINICAL
NEPHROLOGY
MEETINGS
A MULTICENTER STUDY OF THE SAFETY OF INTRAVENOUS IRON DEXTRAN (IVFe) IN HEMODIALYSIS PATIENTS -,S Fishbane V-D Ungureanu, JK Maesaka, G Adam, CJ Kaupke, V Lim, J Wish. Winthrop-Univ. Hosp, Mineola, NY, Univ. of CaliforniaIrvine Med. Ctr., Irvine, CA, Univ. of Iowa, Iowa City, IA, Univ. Hospital of Cleveland, Cleveland, Ohio. The treatment of the anemia of ESRD with rHuEP0 is frequently blunted by the development of inadequate iron stores. Intravenous iron dextran is in common use to treat iron deficiency in this population. The purpose of this study was to evaluate the safety of this medication. Charts were reviewed from 4 HD centers. All patients receiving tx. with IVFe (INFeD, Schein Pharmaceuticals, Inc., Florham Park, NJ) between 7/l/93 and 6/30/95 were studied. A total of 573 patients were studied, of which 27 (4.7%) had adverse reactions (AR). 4 reactions (0.7%) were considered serious (defmed as cardiac arrest-l pt., hopitalization-3 pts., and permanent disability-0 pts). There were no deaths as a result of iVFe tx. In 19 cases (3.3% of pts. treated), the adverse reaction was believed to be probably related to the IVFe. In 8 other cases the relationship of the reaction to IVFe was uncertain, however, these cases were included in the following analysis. 15 reactions (2.6%) led to permanent discontinuance of IVFe. Only 4 reactions occurred during the initial test dose (10,25, or 50 mg) including 1 with cardiac arrest. The most common ARs were prm-itis (1.4%), dyspnea (1.4%) hot flashes and flushing (l.O%), chest pain (0.5%), nausea (0.5%) headache (0.3%), hypotension (O.l%), cardiac arrest (O.l%), abdominal pain (0. I%), back pain (O.l%), myalgias (0.1%) diarrhea (0.1%). Two factors were predictive of patients who developed reactions, a history of any drug allergy (odds ratio 2.4, P=O.O3), and multiple drug allergies (odds ratio 5.5, P=O.O004). In conclusion, we found serious adverse reactions with IVFe in hemodialysis patients to be uncommon. Future, prospective studies would be helpful to confvm this fmding.
ELEVATED INTRACELLULAR CALCIUM IS ASSOCIATED WITH THE DEVELOPMENT OF MICROALBUMINURlA lN ESSENTIAL HYPERTENSION. Ronald L. Fong, Myriam Rodriguez-Laguer, Jay V. Vadgama,and Harry J. Ward. Charles R. Drew and UCLA Schools of Medicine, Los Angeles, CA. Elevated intracellular calcium ([Ca”]r) levels has been proposed as an underlying ionic mechanism for insulin resistance. Microalbuminuria (MA) has been identified as an early marker of microvascular disease and has been linked with alterations in [Ca’+]r metabolism. We evaluated 42 non-diabetic patients with essential hypertension (HTN) to examine the relationship between [Caz’li and the presence of MA. Non-proteinuric hypertensives were assessed for MA by using an antibody-enzyme conjugate assay on a timed overnight collection. [Caz’li levels were determined in fresh platelets by measuring Fura- distribution by spectrofluorometty. [Ca”], levels were grouped by the presence (+) or absence (-) of MA (30300 mg/24 hours). Patients’ therapies for HTN included, but were not limited to, angiotensin-coverting enzyme inhibitors, calcium channel antagonists, and diuretics.
COST MINIMIZATION OF ERYTHROPOIETIN (EPO) AT AN OUTPATIENT HEMODIALYSIS (HD) CENTER. Esther P. Fong, Edward F. Foote, Dong-Churl Suh, Caroline A. Steward, Mildred V. Pickard, Richard A. Sherman. Rutgers College of Pharmacy, Piscataway, NJ, Robert Wood Johnson/DC1 Dialysis Ctr., North Brunswick, NJ. This study quantitated current EPO usage and initiated interventions to reduce cost in our HD unit by maximizing use of EPO overfill (l,OOO-2,000 units/vial) and reducing waste. Our HD center uses 10,000 unit single dose vials exclusively. EPO use was assessed in three phases. Phase I was baseline use, Phase II reflected use after nursing education; Phase III reflected use with the addition of deadspace syringes (MedSaver, Becton-Dickinson Inc.). Nursing education included a review of sterile techniques and EPO cost issues. Partially used vials were refrigerated and saved for the next shift but discarded 14 hours after initial opening. The MedSaver syringe contains a permanently attached needle to the syringe barrel which eliminates approximately 0.075 ml of medication wasted in a standard syringe hub. Utilization was based on chart review of doses administered and physical inventory control. Utilization was defmed as the number of units of EPO recovered per 10,000 unit single dose vial. Phase II and III data ware collected prospectively over one week each and compared to Phase I, baseline EPO use (determined retrospectively over a two month period). Results were: Condition Units recovered uer vial Baseline (Phase I) 9,799 Nursing Education (Phase II) 10,924 Nursing Ed. plus MedSaver (Phase III) 11,780 Based on current EPO usage, an annual cost savings of 17% of total EPO expenditures was calculated (J 145,000 savings for our institution). Nursing education alone accounted for approximately 10% ($88,000) in savings, while the addition of MedSaver syringes produced an additional projected savings of 7% ($57,000). Periodic assessment of utilization under Phase III conditions will be performed for quality control.
EFFECT OF HEMODIALYSIS (HD) ON SIGNAL AVERAGING ECG (ME). lhab G&is. Gabriel Contreras, James Lafferty, Simon Chskko, Judy Mclougblin, Lisa Gualberti, Morton Kleiner, Thomas Costantino, Guido Perez, Kenneth Kessler, Robert Myerburg. Staten Island University Hospital, Staten Island, NY, and University of Miami/VAMC, Miami, FL. The effect of HD on arrhythmic risk is undefined We postulated that electrolytes fluxes during HD may generate late potentials (LP). To demonstrate LP, we performed SAE on 28 ESRD patients immediately before and after HD. The mean QRS duration (QRSd), low amplitude signal duration (LASd), and root-mean-square voltage @MS) were: Pre-HD Post-HD P value QRSd(ms) 103.3 f 13.2 101.3 f 12.9 0.219 LASd(ms) 28.3 f 12.9 24.9 f 10.1 0.041 18.6 f 59.2 63.0 f 56.9 0.007 MS(mV) Results are presented j? f SD. Data were analyzed with Student’s t-test. Normal value: QRSd ~112 ma, LASd 438 ms and RMS >20 mV. Prior to HD eight LP were found in four patients. Post HD only one pient had one LP. Three patients had all seven of their abnormal LP normal&d after HD. In order to assess the role of fluid removal during HD on SAE parameters, we evaluated 12 patients with and without fluid removal. No Fluid Removed Fluid Removed QRSd pre 109.5 f 7.7 108.8 f 7.8 Post 110.4 f 7.6 110.1 * 7.1 LASd pre 26.6 f 8.5 26.2 f 9.2 24.8 f 7.0 25.1 f 9.2 Post RMS pre 43.8 f 23.1 51.0 i26.5 Post 53.3 f 22.6* 51.5 *24.3 Data were analysed by ANOVA with repeated measures. *P-=0.049. We conclude that HD improves SAE parameters and can abolish LP. Fluid removal may be contributing to this effect.
Group MA(+) MA (-)
N 15 27
[Ca”]t (u moles/L) 0.153 +0.021* 0.131 ItO.
MAP (mm Hg) 108.1 + 6.7 102.6 i 7.9
Sir (mgldl) 0.9iO.l 1.0+0.2
* PCO.03 Multivariate analysis showed that [Ca*‘], and MA levels were independent of age, sex, duration of HTN, body mass index, or antihypertensive medication. Differences in mean arterial pressure (MAP) or serum creatinine (S,r) between the two groups were not significant. Our data illustrate that non-diabetic hypertensives with elevated [Caz’li have an increased risk for developing early renal compromise. Abnormal [Caz’li metabolism may modulate smooth muscle’s sensitivity to insulin, resulting in exaggerated vascular contraction and altered vascular permeability. Elevated [Ca”& levels may be an early marker for the development of MA and renal dysfunction in essential HTN.
1996
SPRING
CLINICAL
NEPHROLOGY
MEETINGS
A MULTICENTER STUDY OF THE SAFETY OF INTRAVENOUS IRON DEXTRAN (IVFe) IN HEMODIALYSIS PATIENTS -,S Fishbane V-D Ungureanu, JK Maesaka, G Adam, CJ Kaupke, V Lim, J Wish. Winthrop-Univ. Hosp, Mineola, NY, Univ. of CaliforniaIrvine Med. Ctr., Irvine, CA, Univ. of Iowa, Iowa City, IA, Univ. Hospital of Cleveland, Cleveland, Ohio. The treatment of the anemia of ESRD with rHuEP0 is frequently blunted by the development of inadequate iron stores. Intravenous iron dextran is in common use to treat iron deficiency in this population. The purpose of this study was to evaluate the safety of this medication. Charts were reviewed from 4 HD centers. All patients receiving tx. with IVFe (INFeD, Schein Pharmaceuticals, Inc., Florham Park, NJ) between 7/l/93 and 6/30/95 were studied. A total of 573 patients were studied, of which 27 (4.7%) had adverse reactions (AR). 4 reactions (0.7%) were considered serious (defmed as cardiac arrest-l pt., hopitalization-3 pts., and permanent disability-0 pts). There were no deaths as a result of iVFe tx. In 19 cases (3.3% of pts. treated), the adverse reaction was believed to be probably related to the IVFe. In 8 other cases the relationship of the reaction to IVFe was uncertain, however, these cases were included in the following analysis. 15 reactions (2.6%) led to permanent discontinuance of IVFe. Only 4 reactions occurred during the initial test dose (10,25, or 50 mg) including 1 with cardiac arrest. The most common ARs were prm-itis (1.4%), dyspnea (1.4%) hot flashes and flushing (l.O%), chest pain (0.5%), nausea (0.5%) headache (0.3%), hypotension (O.l%), cardiac arrest (O.l%), abdominal pain (0. I%), back pain (O.l%), myalgias (0.1%) diarrhea (0.1%). Two factors were predictive of patients who developed reactions, a history of any drug allergy (odds ratio 2.4, P=O.O3), and multiple drug allergies (odds ratio 5.5, P=O.O004). In conclusion, we found serious adverse reactions with IVFe in hemodialysis patients to be uncommon. Future, prospective studies would be helpful to confvm this fmding.
ELEVATED INTRACELLULAR CALCIUM IS ASSOCIATED WITH THE DEVELOPMENT OF MICROALBUMINURlA lN ESSENTIAL HYPERTENSION. Ronald L. Fong, Myriam Rodriguez-Laguer, Jay V. Vadgama,and Harry J. Ward. Charles R. Drew and UCLA Schools of Medicine, Los Angeles, CA. Elevated intracellular calcium ([Ca”]r) levels has been proposed as an underlying ionic mechanism for insulin resistance. Microalbuminuria (MA) has been identified as an early marker of microvascular disease and has been linked with alterations in [Ca’+]r metabolism. We evaluated 42 non-diabetic patients with essential hypertension (HTN) to examine the relationship between [Caz’li and the presence of MA. Non-proteinuric hypertensives were assessed for MA by using an antibody-enzyme conjugate assay on a timed overnight collection. [Caz’li levels were determined in fresh platelets by measuring Fura- distribution by spectrofluorometty. [Ca”], levels were grouped by the presence (+) or absence (-) of MA (30300 mg/24 hours). Patients’ therapies for HTN included, but were not limited to, angiotensin-coverting enzyme inhibitors, calcium channel antagonists, and diuretics.
COST MINIMIZATION OF ERYTHROPOIETIN (EPO) AT AN OUTPATIENT HEMODIALYSIS (HD) CENTER. Esther P. Fong, Edward F. Foote, Dong-Churl Suh, Caroline A. Steward, Mildred V. Pickard, Richard A. Sherman. Rutgers College of Pharmacy, Piscataway, NJ, Robert Wood Johnson/DC1 Dialysis Ctr., North Brunswick, NJ. This study quantitated current EPO usage and initiated interventions to reduce cost in our HD unit by maximizing use of EPO overfill (l,OOO-2,000 units/vial) and reducing waste. Our HD center uses 10,000 unit single dose vials exclusively. EPO use was assessed in three phases. Phase I was baseline use, Phase II reflected use after nursing education; Phase III reflected use with the addition of deadspace syringes (MedSaver, Becton-Dickinson Inc.). Nursing education included a review of sterile techniques and EPO cost issues. Partially used vials were refrigerated and saved for the next shift but discarded 14 hours after initial opening. The MedSaver syringe contains a permanently attached needle to the syringe barrel which eliminates approximately 0.075 ml of medication wasted in a standard syringe hub. Utilization was based on chart review of doses administered and physical inventory control. Utilization was defmed as the number of units of EPO recovered per 10,000 unit single dose vial. Phase II and III data ware collected prospectively over one week each and compared to Phase I, baseline EPO use (determined retrospectively over a two month period). Results were: Condition Units recovered uer vial Baseline (Phase I) 9,799 Nursing Education (Phase II) 10,924 Nursing Ed. plus MedSaver (Phase III) 11,780 Based on current EPO usage, an annual cost savings of 17% of total EPO expenditures was calculated (J 145,000 savings for our institution). Nursing education alone accounted for approximately 10% ($88,000) in savings, while the addition of MedSaver syringes produced an additional projected savings of 7% ($57,000). Periodic assessment of utilization under Phase III conditions will be performed for quality control.
EFFECT OF HEMODIALYSIS (HD) ON SIGNAL AVERAGING ECG (ME). lhab G&is. Gabriel Contreras, James Lafferty, Simon Chskko, Judy Mclougblin, Lisa Gualberti, Morton Kleiner, Thomas Costantino, Guido Perez, Kenneth Kessler, Robert Myerburg. Staten Island University Hospital, Staten Island, NY, and University of Miami/VAMC, Miami, FL. The effect of HD on arrhythmic risk is undefined We postulated that electrolytes fluxes during HD may generate late potentials (LP). To demonstrate LP, we performed SAE on 28 ESRD patients immediately before and after HD. The mean QRS duration (QRSd), low amplitude signal duration (LASd), and root-mean-square voltage @MS) were: Pre-HD Post-HD P value QRSd(ms) 103.3 f 13.2 101.3 f 12.9 0.219 LASd(ms) 28.3 f 12.9 24.9 f 10.1 0.041 18.6 f 59.2 63.0 f 56.9 0.007 MS(mV) Results are presented j? f SD. Data were analyzed with Student’s t-test. Normal value: QRSd ~112 ma, LASd 438 ms and RMS >20 mV. Prior to HD eight LP were found in four patients. Post HD only one pient had one LP. Three patients had all seven of their abnormal LP normal&d after HD. In order to assess the role of fluid removal during HD on SAE parameters, we evaluated 12 patients with and without fluid removal. No Fluid Removed Fluid Removed QRSd pre 109.5 f 7.7 108.8 f 7.8 Post 110.4 f 7.6 110.1 * 7.1 LASd pre 26.6 f 8.5 26.2 f 9.2 24.8 f 7.0 25.1 f 9.2 Post RMS pre 43.8 f 23.1 51.0 i26.5 Post 53.3 f 22.6* 51.5 *24.3 Data were analysed by ANOVA with repeated measures. *P-=0.049. We conclude that HD improves SAE parameters and can abolish LP. Fluid removal may be contributing to this effect.
Group MA(+) MA (-)
N 15 27
[Ca”]t (u moles/L) 0.153 +0.021* 0.131 ItO.
MAP (mm Hg) 108.1 + 6.7 102.6 i 7.9
Sir (mgldl) 0.9iO.l 1.0+0.2
* PCO.03 Multivariate analysis showed that [Ca*‘], and MA levels were independent of age, sex, duration of HTN, body mass index, or antihypertensive medication. Differences in mean arterial pressure (MAP) or serum creatinine (S,r) between the two groups were not significant. Our data illustrate that non-diabetic hypertensives with elevated [Caz’li have an increased risk for developing early renal compromise. Abnormal [Caz’li metabolism may modulate smooth muscle’s sensitivity to insulin, resulting in exaggerated vascular contraction and altered vascular permeability. Elevated [Ca”& levels may be an early marker for the development of MA and renal dysfunction in essential HTN.