Multimorbidity in Atherosclerotic Cardiovascular Disease and Its Associations With Adverse Cardiovascular Events and Healthcare Costs: A Real-World Evidence Study.

Background: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of mortality and disability in the United States and worldwide. Objective: To assess the multimorbidity burden and its associations with adverse cardiovascular events (ACE) and healthcare costs among patients with ASCVD. Methods: This is a retrospective observational cohort study using Aetna claims database. Patients with ASCVD were identified during the study period (1/1/2018-10/31/2021). The earliest ASCVD diagnosis date was identified as the index date. Qualified patients were ≥18 years of age and had ≥12 months of health plan enrollment before and after the index date. Comorbid conditions were assessed using all data available within 12 months prior to and including the index date. Association rule mining was applied to identify comorbid condition combinations. ACEs and healthcare costs were assessed using all data within 12 months after the index date. Multivariable generalized linear models were performed to examine the associations between multimorbidity and ACEs and healthcare costs. Results: Of 223 923 patients with ASCVD (mean [SD] age, 73.6 [10.7] years; 42.2% female), 98.5% had ≥2, and 80.2% had ≥5 comorbid conditions. The most common comorbid condition dyad was hypertension-hyperlipidemia (78.7%). The most common triad was hypertension-hyperlipidemia-pain disorders (61.1%). The most common quartet was hypertension-hyperlipidemia-pain disorders-diabetes (30.2%). The most common quintet was hypertension-hyperlipidemia-pain disorders-diabetes-obesity (16%). The most common sextet was hypertension-hyperlipidemia-pain disorders-diabetes-obesity-osteoarthritis (7.6%). The mean [SD] number of comorbid conditions was 7.1 [3.2]. The multimorbidity burden tended to increase in older age groups and was comparatively higher in females and in those with higher social vulnerability. The increased number of comorbid conditions was significantly associated with increased ACEs and increased healthcare costs. Discussion: Extremely prevalent multimorbidity should be considered in the context of clinical decision-making to optimize secondary prevention of ASCVD. Conclusions: Multimorbidity was extremely prevalent among patients with ASCVD. Multimorbidity patterns varied considerably across ASCVD patients and by age, gender, and social vulnerability status. Multimorbidity was strongly associated with ACEs and healthcare costs.

The Joint Association of Fitness and Fatness on Cardiovascular Disease Mortality: A Meta-Analysis.

The joint association of cardiorespiratory fitness (CRF) and body mass index (BMI) on cardiovascular disease (CVD) mortality was determined. PubMed and CINAHL were searched following PRISMA guidelines. Included studies were prospective, had objective assessments of maximal CRF and BMI, and compared the joint impact of CRF and BMI on CVD mortality risk to normal weight, fit referents. Pooled hazard ratios and 95% confidence intervals were calculated from eight articles with nine independent groups using a random effects model. Unfit individuals had two to three times the risk of mortality across all levels of BMI. Overweight and obese-fit individuals had 25% and 42% increased mortality risk, respectively, compared to normal weight-fit individuals. However, for the obese-fit group, a one study removed analysis for five studies resulted in non-significant changes in mortality risk. Researchers, clinicians, and public health officials are encouraged to employ CRF interventions to reduce CDV mortality risk.

Impact of EPOC adjustment on estimation of energy expenditure using activity monitors.

PURPOSE: To examine the accuracy of activity monitors in estimating energy expenditure (EE) during activities of varying mode and intensity and to evaluate the impact of including energy expended during recovery from activity (EPOC) on the EE estimate. EE estimates obtained from the Fitbit Surge (FBS), Garmin Vívofit (GV) and SenseWear Armband Mini (SWA) were compared to criterion EE with and without EPOC adjustments during moderate- and vigorous-intensity treadmill and cycling activities. METHODS: Participants (N = 34; 23 males) completed counterbalanced treadmill or cycling conditions, comprised of a resting metabolic rate measurement, 10-min bouts of moderate- and vigorous-intensity activity and an EPOC measurement. Participants simultaneously wore the three activity monitors and a portable metabolic analyser. RESULTS: The FBS provided lowest percent error (PE) during treadmill walking (4.4%) and the GV during moderate (6.4%) and vigorous (-0.1%) cycling bouts. EPOC-adjusted PE was higher than non-EPOC PE across all monitors and activities. Mean absolute error rate (MAPE), indicating overall measurement error, was the smallest for the FBS (14.1%) during moderate treadmill walking and the largest for the SWA (53.5%) for vigorous intensity cycling. Only the FBS had comparable non-EPOC (14.6%) and EPOC-adjusted (17.6%) MAPE during treadmill walking. CONCLUSION: The activity monitors tended to underestimate EE during moderate and vigorous treadmill and cycling activities. The EE estimates from the activity monitors did not account for the energy cost met by anaerobic means during activity, as suggested by the higher EPOC-adjusted EE error rates.

An Evaluation of Time-Trial-Based Predictions of V[Combining Dot Above]O2max and Recommended Training Paces for Collegiate and Recreational Runners.

Scudamore, EM, Barry, VW, and Coons, JM. An Evaluation of time-trial-based predictions of V[Combining Dot Above]O2max and recommended training paces for collegiate and recreational runners. J Strength Cond Res 32(4): 1137-1143, 2018-The purpose of the current study was to determine the accuracy of Jack Daniels' VDOT Running Calculator for the prediction of V[Combining Dot Above]O2max, and recommendations of interval and training paces (pIN and pTH) in samples of National Collegiate Athletic Association Division 1 track athletes (ATH, n = 11) and recreational runners (REC; n = 9). Predicted variable data were obtained using results from indoor 5-km time-trials. Data from the VDOT Calculator were compared with laboratory-tested V[Combining Dot Above]O2max, pace at V[Combining Dot Above]O2max (V[Combining Dot Above]O2maxpace), and lactate threshold pace (LTpace). Results indicated that VDOT underestimated V[Combining Dot Above]O2max in ATH (t(10) = -6.00, p < 0.001, d = 1.75) and REC (t(8) = -8.96, p < 0.001, d = 3.44). Follow-up between-groups analysis indicated that the difference between VDOT and V[Combining Dot Above]O2max was significantly greater in REC than in ATH (p = 0.0031, d = 1.59). pIN was slower than V[Combining Dot Above]O2maxpace in REC (t(8) = -4.26, p = 0.003, d = 1.76), but not different in ATH (t(10) = 0.52, p = 0.614, d = 0.14). Conversely, pTH was faster than LTpace in ATH (t(8) = -4.17, p = 0.003, d = 1.49), but not different in REC (t(8) = 1.64, p = 0.139, d = 0.57). Practically, pTH can be confidently used for threshold training regardless of the ability level. pIN also seemed to be accurate for ATH, but may be not be optimal for improving V[Combining Dot Above]O2max in REC. Practitioners should interpret VDOT with caution as it may underestimate V[Combining Dot Above]O2max.

Effect of Caffeine on near Maximal Blood Pressure and Blood Pressure Recovery in Physically-Active, College-Aged Females.

The purpose of this study is to determine how caffeine affects exercise blood pressure (BP) and active and passive recovery BP after vigorous intensity exercise in physically active college-aged females. Fifteen physically active, ACSM stratified low-risk females (age (y): 23.53 ± 4.07, weight (kg): 60.34 ± 3.67, height (cm): 165.14 ± 7.20, BMI (kg/m2): 22.18 ± 1.55) participated in two Bruce protocol exercise tests. Before each test participants consumed 1) a placebo or 2) 3.3 mg·kg-1 of caffeine at least one hour before exercise in a counterbalanced double-blinded fashion. After reaching 85% of their age-predicted maximum heart rate, BP was taken and participants began an active (i.e. walking) recovery phase for 6 minutes followed by a passive (i.e. sitting) recovery phase. BP was assessed every two minutes in each phase. Recovery times were assessed until active and passive BP equaled 20 mmHg and 10 mmHg above resting, respectively. Participants completed each test 1-2 weeks a part. Maximal systolic and diastolic blood pressures were not significantly different between the two trials. Active recovery, passive recovery, and total recovery times were all significantly longer during the caffeine trial than the placebo trial. Furthermore, the time to reach age-predicted maximum heart rate was significantly shorter in the placebo trial than the caffeine trial. While caffeine consumption did not significantly affect maximal blood pressure, it did affect active and passive recovery time following vigorous intensity exercise in physically active females. Exercise endurance also improved after consuming caffeine in this population.

Vascular access placement in patients with chronic kidney disease Stages 4 and 5 attending an inner city nephrology clinic: a cohort study and survey of providers.

BACKGROUND: The majority of incident hemodialysis (HD) patients initiate dialysis via catheters. We sought to identify factors associated with initiating hemodialysis with a functioning arterio-venous (AV) access. METHODS: We conducted a retrospective chart review of all adult patients, age >18 years seeing a nephrologist with a diagnosis of CKD stage 4 or 5 during the study period between 06/01/2011 and 08/31/2013 to evaluate the placement of an AV access, initiation of dialysis and we conducted a survey of providers about the process. RESULTS: The 221 patients (56% female) in the study had median age of 66 years (interquartile range (IQR), 57-75) and were followed for a median of 1.26 years (IQR 0.6-1.68). At study entry, 81%had CKD stage 4 and 19% had CKD stage 5. By the end of study, 48 patients had initiated dialysis. Thirty-four of the patients started dialysis with a catheter (1 failed and 10 maturing AVFs), 9 with an AVF and 5 with an AVG. During the study period, 61 total AV accesses were placed (54 AVF and 7 AVG). A higher urinary protein/ creatinine ratio and a lower eGFR were associated with AV access placement and dialysis initiation. A greater number of nephrology visits were associated with AV access creation but not dialysis initiation. Hospitalizations and hospitalizations with an episode of acute kidney injury (AKI) were strongly associated with dialysis initiation (odds ratio (OR) 13.0 (95% confidence interval (CI) 2.3 to 73.3, p-value = 0.004) and OR 6.6 (95% CI 1.9 to 22.8, p-value = 0.003)). CONCLUSIONS: More frequent nephrology clinic visits for patients with a recent hospitalization may improve rates of placement of an AV access. A hospitalization with AKI is strongly associated with the need for dialysis initiation. Nephrologists may not be referring the correct patients to get an AV access surgery.

Hidden Obesity in Dialysis Patients: Clinical Implications.

While body-mass index (BMI) is used to diagnose obesity in the general population, its application in the end-stage renal disease (ESRD) population is fraught with difficulty. A major limitation is its inability to distinguish muscle mass from fat mass, thereby leading to misclassification of individuals with poor muscle mass but excess adipose tissue as non-obese (i.e. BMI <30 kg/m(2) ). As muscle wasting is common among ESRD patients, this is an important problem. A substantial proportion of ESRD patients have levels of BMI in the normal range, yet excess adiposity based on other measures. The importance of this "hidden" obesity remains to be determined, but it must be recognized in order for obesity interventions to be appropriately targeted and tested in the ESRD population.

Variability in monthly serum bicarbonate measures in hemodialysis patients: a cohort study.

BACKGROUND: Some nephrologists have advocated an individualized approach to the prescription of bicarbonate hemodialysis. However, the utility of monthly serum bicarbonate levels for guiding and evaluating such treatment decisions has not been evaluated. We sought to define the variability of these measurements and to determine factors that are associated with month-to-month variability in pre-dialysis serum bicarbonate. METHODS: We examined the monthly variability in serum bicarbonate measurements among 181 hemodialysis patients admitted to a free-standing dialysis unit in the Bronx, NY from 1/1/2008-6/30/2012. All patients were treated with a uniform bicarbonate dialysis prescription (bicarbonate 35 mEq/L, acetate 8 mEq/L). Pre-dialysis serum bicarbonate values were obtained from monthly laboratory reports. Month-to-month variability was defined using a rolling measurement for each time point. RESULTS: Only 34 % of high serum bicarbonate values (>26 mEq/L) remained high in the subsequent month, whereas 60 % converted to normal (22-26 mEq/L). Of all low values (<22 mEq/L), 41 % were normal the following month, while 58 % remained low. Using the mean 3-month bicarbonate, only 29 % of high values remained high in the next 3-month period. In multivariable-adjusted longitudinal models, both low and high serum bicarbonate values were associated with greater variability than were normal values (ß = 0.12 (95 % CI 0.09-0.15) and 0.24 (0.18 to 0.29) respectively). Variability decreased with time, and was significantly associated with age, phosphate binder use, serum creatinine, potassium, and normalized protein catabolic rate. CONCLUSIONS: Monthly pre-dialysis serum bicarbonate levels are highly variable. Even if a clinician takes no action, approximately 50 % of bicarbonate values outside a normal range of 22-26 mEq/L will return to normal in the subsequent month. The decision to change the bicarbonate dialysis prescription should not be based on a single bicarbonate value, and even a 3-month mean may be insufficient.

Live vs. digital video disk exercise in college--aged females.

Although exercise digital video disk (DVD) sales have substantially increased over the past decade, little is known on the effectiveness of personal training vs. DVD exercises. The purpose of this study was to compare energy expenditures and heart rates of live and DVD vigorously intense exercise sessions. Twenty active and low-to-moderate fit, college-aged females completed 2 identical exercise sessions. Each exercise session consisted of 6 exercises; 1 session was completed with a personal trainer and the other with a DVD. A portable metabolic analyzer was used to measure oxygen consumption and record heart rate. Both energy expenditure (p < 0.001) and heart rate (p = 0.001) were significantly higher during the live exercise session as compared with the DVD exercise session. Rate of perceived exertion was significantly higher for the live exercise session compared with the DVD exercise session (p = 0.045). Finally, the majority (89%) of the participants reported that they preferred the live exercise session over the DVD exercise session. The results suggest that low-to-moderately fit college-aged females not only prefer exercise sessions with a personal trainer but will also demonstrate higher energy expenditures and heart rates.

Fitness vs. fatness on all-cause mortality: a meta-analysis.

The purpose of this study was to quantify the joint association of cardiorespiratory fitness (CRF) and weight status on mortality from all causes using meta-analytical methodology. Studies were included if they were (1) prospective, (2) objectively measured CRF and body mass index (BMI), and (3) jointly assessed CRF and BMI with all-cause mortality. Ten articles were included in the final analysis. Pooled hazard ratios were assessed for each comparison group (i.e. normal weight-unfit, overweight-unfit and -fit, and obese-unfit and -fit) using a random-effects model. Compared to normal weight-fit individuals, unfit individuals had twice the risk of mortality regardless of BMI. Overweight and obese-fit individuals had similar mortality risks as normal weight-fit individuals. Furthermore, the obesity paradox may not influence fit individuals. Researchers, clinicians, and public health officials should focus on physical activity and fitness-based interventions rather than weight-loss driven approaches to reduce mortality risk.

Sleep Problems, Suicidality and Depression among American Indian Youth.

STUDY BACKGROUND: Mental health and sleep problems are important public health concerns among adolescents yet little is known about the relationship between sleep, depressive symptoms, and suicidality among American Indian youth. METHODS: This study examined the impact of sleep and other factors on depressive symptoms and suicidality among Lumbee American Indian adolescents (N=80) ages 11-18. RESULTS: At the bivariate level, sleepiness, was associated with depression but not with suicidality. Time in bed (TIB) was not associated with depression, but more TIB decreased the likelihood of suicidality. Higher levels of depressive symptoms were associated with increased likelihood of suicidality. At the multivariate level, sleepiness, suicidality, and self-esteem were associated with depression. TIB and depressive symptoms were the only variables associated with suicidality. CONCLUSION: In working with American Indian youth, it may be helpful to consider sleep patterns as part of a comprehensive assessment process for youth who have or are at risk for depression and suicide.

Cardiometabolic results from an armband-based weight loss trial.

PURPOSE: This report examines the blood chemistry and blood pressure (BP) results from the Lifestyle Education for Activity and Nutrition (LEAN) study, a randomized weight loss trial. A primary purpose of the study was to evaluate the effects of real-time self-monitoring of energy balance (using the SenseWear(™) Armband, BodyMedia, Inc Pittsburgh, PA) on these health factors. METHODS: 164 sedentary overweight or obese adults (46.8 ± 10.8 years; BMI 33.3 ± 5.2 kg/m(2); 80% women) took part in the 9-month study. Participants were randomized into 4 conditions: a standard care condition with an evidence-based weight loss manual (n = 40), a group-based behavioral weight loss program (n = 44), an armband alone condition (n = 41), and a group plus armband (n = 39) condition. BP, fasting blood lipids and glucose were measured at baseline and 9 months. RESULTS: 99 participants (60%) completed both baseline and follow-up measurements for BP and blood chemistry analysis. Missing data were handled by baseline carried forward. None of the intervention groups had significant changes in blood lipids or BP when compared to standard care after adjustment for covariates, though within-group lowering was found for systolic BP in group and group + armband conditions, a rise in total cholesterol and LDL were found in standard care and group conditions, and a lowering of triglycerides was found in the two armband conditions. Compared with the standard care condition, fasting glucose decreased significantly for participants in the group, armband, and group + armband conditions (all P < 0.05), respectively. CONCLUSION: Our results suggest that using an armband program is an effective strategy to decrease fasting blood glucose. This indicates that devices, such as the armband, can be a successful way to disseminate programs that can improve health risk factors. This can be accomplished without group-based behavioral programs, thereby potentially reducing costs.

Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial.

BACKGROUND: The SenseWear™ Armband (SWA) (BodyMedia, Inc. Pittsburgh, PA) is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes. METHODS: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI), 33.3 ± 5.2 kg/m(2); 81% women, 32% African-American) from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50), a group-based behavioral weight loss program (GWL, n = 49), the armband alone (SWA-alone, n = 49), or the GWL plus the armband (GWL+SWA, n = 49), during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave. RESULTS: Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention). There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P < 0.0001) but not in the Standard Care group (0.89 kg, P = 0.39) at month 9. Only the GWL+SWA group achieved significant weight loss at month 9 compared to the Standard Care group (P = 0.04). Significant waist circumference reductions were achieved in all 4 groups at month 9 (Standard Care, 3.49 cm, P = 0.0004; GWL, 2.42 cm, P = 0.008; SWA-alone, 3.59 cm, P < 0.0001; GWL+SWA, 6.77 cm, P < 0.0001), but no intervention group had significantly reduced waist circumference compared to the Standard Care group. CONCLUSIONS: Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss.

Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design.

PURPOSE: The SenseWear™ Armband is an activity monitor developed to improve lifestyle self-monitoring. Currently, few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program. To our knowledge, only one study has used the SenseWear Armband in combination with a lifestyle intervention to improve weight loss, and no studies have evaluated whether a self-monitoring intervention based solely on the armband can promote weight loss. Consequently, the aims of the study were to assess weight loss from electronic self-monitoring, to compare these values to the lifestyle intervention and standard care groups, and to compare weight loss with lifestyle intervention with and without the armband. PATIENTS AND METHODS: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 years; BMI, 33.3 ± 5.2 kg/m(2)) to participate in the 9-month study. Participants were randomized into one of four weight loss groups: 1) the standard care group received a self-directed weight loss program, complete with an evidence-based weight loss manual (standard care, n = 50); 2) a 14-week group-based behavioral weight loss program followed by weekly, biweekly, and monthly telephone counseling calls (GWL, n = 49); 3) the use of the armband to help improve lifestyle self-monitoring (SWA alone, n = 49); or (4) the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armband (GWL + SWA, n = 49). All participants received the evidence-based weight loss manual at baseline. All measures were performed at baseline and months 4 and 9. The primary outcomes were weight loss and waist circumference reduction. RESULTS: This study is a well-designed randomized controlled study powered to detect a 0.5-kg weight loss and 0.6-cm waist circumference reduction in overweight and obese sedentary adults. CONCLUSION: Innovative technologies are providing lifestyle self-monitoring and weight loss tools. Utilizing these technologies may be an important step in improving the current obesity epidemic.

Renal function recovery in chronic dialysis patients.

Renal function recovery (RFR) from acute kidney injury requiring dialysis occurs at a high frequency. RFR from chronic dialysis, on the other hand, is an uncommon but well-recognized phenomenon, occurring at a rate of 1.0-2.4% according to data from large observational studies. The underlying etiology of renal failure is the single most important predicting factor of RFR in chronic dialysis patients. The disease types with the highest RFR rates are atheroembolic renal disease, systemic autoimmune disease, renovascular diseases, and scleroderma. The disease types with the lowest RFR rates are diabetic nephropathy and cystic kidney disease. Initial dialysis modality does not appear to influence RFR. Careful observation and history taking are needed to recognize the often nonspecific clinical and laboratory signs of RFR. When RFR is suspected in a chronic dialysis patient, a 24-hour urine urea and creatinine clearance should be measured. Based on the renal clearance, along with other clinical factors, the dialysis prescription may be gradually reduced until a complete discontinuation of dialysis. After RFR from maintenance dialysis, patients require close follow-up in an office setting for chronic kidney disease management.

Sodium ferric gluconate complex in haemodialysis patients: a prospective evaluation of long-term safety.

BACKGROUND: A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. METHODS: Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250 mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. RESULTS: Among 1412 enrolled patients at 54 centres, 1321 received 13,151 infusions of SFGC. Most doses (94.8%) were < or =125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. CONCLUSIONS: Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13,000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

Intravenous iron therapy in chronic kidney disease and peritoneal dialysis patients.

Identical National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) hematologic and iron targets apply to chronic kidney disease (CKD), peritoneal dialysis (PD), and hemodialysis (HD) patients, yet intravenous (i.v.) nondextran iron therapy is FDA approved only in HD patients. This is because oral iron has been considered adequate in CKD and PD patients, and delivering a parenteral therapy on a frequent basis to an outpatient population with notoriously poor vascular access presents logistical complexities. However, recognition of the need for more aggressive treatment of anemia in the CKD and PD population is growing. This awareness, along with the improved safety profiles of the new, nondextran irons, is tipping the risk-benefit ratio toward more widespread use of i.v. iron in these patients. This article provides a summary of the literature and of our own experience using i.v. iron therapy in CKD and PD patients. Our protocol relies on early monitoring and intervention with i.v. ferric gluconate before severe iron deficiency develops. The proactive approach allows for relatively infrequent treatments at only moderately "high" doses (250 mg) of ferric gluconate. The convergence of convenience and safety may expedite more energetic anemia prevention and treatment in PD and CKD patients.

Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration.

BACKGROUND: Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients. METHODS: The authors reviewed the safety and tolerability of higher-dose SFGC infusions (> or =250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of > or =250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min. RESULTS: Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC. CONCLUSION: Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses.