International Anemia Prevalence and Management in Peritoneal Dialysis Patients

2019 ◽  
Vol 39 (6) ◽  
pp. 539-546 ◽  
Author(s):  
Rachel L. Perlman ◽  
Junhui Zhao ◽  
Douglas S. Fuller ◽  
Brian Bieber ◽  
Yun Li ◽  
...  

Background The optimal treatment for managing anemia in peritoneal dialysis (PD) patients and best clinical practices are not completely understood. We sought to characterize international variations in anemia measures and management among PD patients. Methods The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) enrolled adult PD patients from 6 countries from 2014 to 2017. Hemoglobin (Hb), ferritin levels, and transferrin saturation (TSAT), as well as erythropoiesis stimulating agents (ESAs) and iron use were compared cross-sectionally at study enrollment in Australia and New Zealand (A/NZ), Canada, Japan, the United Kingdom (UK), and the United States (US). Results Among 3,603 PD patients from 193 facilities, mean Hb ranged from 11.0 – 11.3 g/dL across countries. The majority of patients (range 53% – 59%) had Hb 10 – 11.9 g/dL, with 4% – 12% patients ≥ 13 g/dL and 16% – 23% < 10 g/dL. Use of ESAs was higher in Japan (94% of patients) than elsewhere (66% – 79% of patients). In the US, 63% of patients had a ferritin level > 500 ng/mL, compared with 5% – 38% in other countries. In the US and Japan, 87% – 89% of PD patients had TSAT ≥ 20%, compared with 73% – 76% in other countries. Intravenous (IV) iron use within 4 months of enrollment was higher in the US (55% of patients) than elsewhere (6% – 17% patients). Conclusions In this largest international observational study of anemia and anemia management in patients receiving PD, comparable Hb levels across countries were observed but with notable differences in ESA and iron use. Peritoneal dialysis patients in the US have higher ferritin levels and higher IV iron use than other countries.

2002 ◽  
Vol 22 (1) ◽  
pp. 60-66 ◽  
Author(s):  
Elisabeth Dittrich ◽  
Martin Schillinger ◽  
Gere Sunder–Plassmann ◽  
Walter H. Hörl ◽  
Andreas Vychytil

Objective Sufficient iron substitution leads to a decrease in the required recombinant human erythropoietin (rHuEPO) dose and/or an increased hematocrit in dialysis patients. Intravenous (IV) application of larger doses of iron sucrose may be associated with hyperferritinemia, appearance of catalytically free iron, and impaired phagocyte function. Therefore, we investigated the effectiveness of a low-dose IV iron regimen in peritoneal dialysis (PD) patients. Patients and Interventions Forty-five PD patients were followed over a period of 1 year. Serum ferritin, serum transferrin saturation, and hemoglobin were measured monthly. In cases of absolute iron deficiency (serum ferritin < 100 μg/L), 50 mg iron sucrose was given IV every second week. In cases of functional iron deficiency (ferritin ≥ 100 μg/L and transferrin saturation < 20%) and in iron repleted patients (ferritin ≥ 100 μg/L and transferrin saturation ≥ 20%), 50 mg IV iron sucrose was applied monthly. Iron therapy was stopped in cases of acute infection (until complete recovery) and when serum ferritin level was ≥ 600 μg/L. Results To analyze the influence of iron substitution on erythropoiesis and rHuEPO requirements, the EPO resistance index (ERI; quotient of rHuEPO dose in units/kilogram/week and hemoglobin in grams per deciliter) was calculated every 3 months. The ERI decreased significantly during the course of the study in the whole patient group ( p = 0.009) as well as in the subgroup of 21 patients with absolute iron deficiency ( p = 0.01). A nonsignificant decrease in the ERI was observed within the group of 14 iron repleted patients ( p = 0.5). There was no significant change in the ERI in 10 patients with functional iron deficiency ( p = 0.6). Conclusion The low-dose IV iron regimen used in this study substantially decreased rHuEPO requirements in patients with absolute iron deficiency and was effective in maintaining iron stores in iron repleted patients. However, in the absence of significant hyperparathyroidism, aluminum toxicity, or inadequate dialysis, it did not improve the ERI in patients with functional iron deficiency.


2019 ◽  
Vol 39 (2) ◽  
pp. 103-111 ◽  
Author(s):  
Karthik Tennankore ◽  
Junhui Zhao ◽  
Angelo Karaboyas ◽  
Brian A. Bieber ◽  
Bruce M. Robinson ◽  
...  

Background Little is known about the prevalence of functional impairment in peritoneal dialysis (PD) patients, its variation by country, and its association with mortality or transfer to hemodialysis. Methods A prospective cohort study was conducted in PD patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) (2014 – 2017). Functional status (FS) was assessed by combining self-reports of 8 instrumental and 5 basic activities of daily living, using the Lawton-Brody and the Katz questionnaires. Summary FS scores, ranging from 1.25 (most dependent) to 13 (independent), were based on the patient's ability to perform each activity with or without assistance. Logistic regression was used to estimate the odds ratio (OR; 95% confidence interval [CI]) of a FS score < 11 comparing each country with the United States (US). Cox regression was used to estimate the hazard ratio (HR; 95% CI) for the effect of a low FS score on mortality and transfer to hemodialysis, adjusting for case mix. Results Of 2,593 patients with complete data on FS, 48% were fully independent (FS = 13), 32% had a FS score 11 to < 13, 14% had a FS score 8 to < 11, and 6% had a FS score < 8. Relative to the US, low FS scores (< 11; more dependent) were more frequent in Thailand (OR = 10.48, 5.90 – 18.60) and the United Kingdom (UK) (OR = 3.29, 1.77 – 6.08), but similar in other PDOPPS countries. The FS score was inversely and monotonically associated with mortality but not with transfer to hemodialysis; the HR, comparing a FS score < 8 vs 13, was 4.01 (2.44 – 6.61) for mortality and 0.91 (0.58 – 1.43) for transfer to hemodialysis. Conclusion Regional differences in FS scores observed across PDOPPS countries may have been partly due to differences in regional patient selection for PD. Functional impairment was associated with mortality but not with permanent transfer to hemodialysis.


2015 ◽  
Vol 41 (4-5) ◽  
pp. 354-361 ◽  
Author(s):  
James B. Wetmore ◽  
Yi Peng ◽  
Keri L. Monda ◽  
Allyson M. Kats ◽  
Deborah H. Kim ◽  
...  

Background/Aims: Recent changes in clinical practice guidelines and reimbursement policies may have affected the use of anemia-related medications and red blood cell (RBC) transfusions in peritoneal dialysis (PD) and hemodialysis (HD) patients. We sought to compare patterns of erythropoiesis-stimulating agents (ESA) and intravenous (IV) iron use, achieved hemoglobin levels, and RBC transfusion use in PD and HD patients. Methods: In quarterly cohorts of prevalent dialysis patients receiving persistent therapy (>3 months), 2007-2011, with Medicare Parts A and B coverage, we assessed ESA and IV iron use and dose, RBC transfusions, and hemoglobin levels. Quarterly transfusion rates were calculated. Results: Observable PD and HD patients numbered 14,958 and 221,866 in Q1/2007 and 17,842 and 256,942 in Q4/2011. Adjusted ESA use was lower in PD (71.4-80.1%) than in HD (86.9-92.0%) patients, decreasing from 80.1% (Q1/2010) to 71.4% (Q4/2011) in PD patients, and from 92.0 to 86.9% in HD patients. The mean adjusted ESA dose decreased by 67.5% in PD and 58.4% in HD patients. IV iron use tended to increase, peaking at 39.3% for PD (Q3/2011) and 80.5% for HD (Q2/2011) patients. Adjusted mean hemoglobin levels fell from 11.7 to 10.6 mg/dl in PD and from 12.0 to 10.7 mg/dl in HD ESA users; adjusted transfusion rates increased from 2.4 to 3.0 per 100 patient-months in PD and from 2.6 to 3.3 in HD patients. Conclusions: In patients receiving persistent dialysis, dose and frequency of ESA administrations decreased during the period 2007-2011. Mean hemoglobin levels decreased by more than 1 g/dl, while transfusion rates increased by approximately 25%.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 308-308
Author(s):  
Young Hee Nam ◽  
Aaron Mendelsohn ◽  
James Marshall ◽  
Nancy Lin ◽  
Jeffrey Brown ◽  
...  

308 Background: Biosimilars for trastuzumab, a HER2 inhibitor (HER2I), have been available for use in the US since in 2019, yet information on their utilization and patient characteristics is limited. We assessed utilization and patient characteristics for the trastuzumab originator, biosimilars, and other HER2Is in the US. Methods: We analyzed healthcare claims for 10/1/2016-up to 2/29/2020 (end date varied across health plans) from the Biologics and Biosimilars Collective Intelligence Consortium’s Distributed Research Network ( > 95 million persons) using the FDA’s Sentinel distributed analysis tools. We conducted descriptive analyses on the number of incident users and patients’ characteristics for each HER2I. Adults continuously enrolled in their health plan with medical and drug coverage ≥365 days (baseline period) prior to their incident HER2I use were eligible for analysis. Results: Of the incident users (incident to any HER2Is), we identified 6,631 originator trastuzumab users, 122 trastuzumab-anns, 116 ado-trastuzumab emtansine, 54 neratinib, and 54 lapatinib users. Trastuzumab-dkst and trastuzumab/hyaluronidase-oysk had < 11 users each. Mean age was the highest for trastuzumab/hyaluronidase-oysk (73.7 years; SD, 18.6) and similar between the trastuzumab originator and biosimilars (52.5-59.0). The number of incident users/100,000 person-years decreased for the trastuzumab originator from 13.5 in 2016 to 9.4 in 2020 and increased for trastuzumab-anns from 0.4 in 2019 to 4.9 in 2020. Of the baseline clinical characteristics examined, Charlson/Elixhauser comorbidity score was the highest for lapatinib (2.0), lowest for trastuzumab-dkst and neratinib (0.5), and similar between the trastuzumab originator (1.1) and trastuzumab-anns (1.3). The proportion of patients who received any chemotherapy during the baseline period was 38.9% for lapatinib, 18.5% for the trastuzumab originator, and 14.8% for trastuzumab-anns. The proportion of endocrine therapy users was the highest for neratinib (63.0%) and similar between the trastuzumab originator (11.1%) and trastuzumab-anns (10.7%). Among incident users with metastatic breast cancer, endocrine therapy receivers during the baseline period accounted for 19.3% for the trastuzumab originator and 69.6% for lapatinib. Conclusions: Though full data were not available for 2019-2020 for all health plans, these preliminary findings suggest that utilization of biosimilar trastuzumab-anns increased whereas the trastuzumab originator use decreased over time and that there is a variation in patient characteristics between HER2Is and by metastatic status while the characteristics were generally similar between the trastuzumab originator and trastuzumab-anns. We plan to conduct ongoing assessment of HER2I utilization as more data become available to help inform clinical practices and health policies.


2006 ◽  
Vol 134 (3-4) ◽  
pp. 133-137 ◽  
Author(s):  
Mirjana Lausevic ◽  
Vidosava Nesic ◽  
Natasa Jovanovic ◽  
Biljana Stojimirovic

A normocytic normochromic anemia is one of the first signs of renal failure. Since anemia increases morbidity and mortality, its elimination is one of the essential objectives of the treatment. Human recombinant erythropoietin (rHuEPO) has changed the therapeutical approach to anemia. The aim of the present study was to compare efficacy of anemia correction in peritoneal dialysis patients depending on treatment and dialysis modality. The study is the retrospective analysis of 64 patients who presented to our Clinic in 2003. Eighteen (28.13%) patients were treated with rHuEPO, 14 (28%) underwent continuous ambulatory peritoneal dialysis (CAPD), 2 (100%) - automated peritoneal dialysis (APD) and 2 (33.3%) - intermittent peritoneal dialysis (IPD). Mean hemoglobin level was 98.6?17.82 g/l in patients treated with rHuEPO versus 98.81?15.14 g/I in patients without rHuEPO treatment. Erythropoietin requirements were 3392.85?1211.77 IU/week. AII patients received iron supplementation during rHuEPO therapy. Mean serum ferritin levels were 463.41 ?360 ?g/l. Transferrin saturation (TSAT) was 0.35?0.16%. No difference of serum iron and TSAT levels was found between CAPD and IPD patients. The degree of anemia significantly differed between CAPD and IPD patients. A total of 17.11% of PD patients were given blood transfusions, most frequently during the first three months after the onset of dialysis. Our conclusion is that the number of patients receiving rHuEPO should be increased, as 50% of our patients should be substituted, while only 28% are being treated. As 50% of patients receiving rHuEPO failed to reach target Hgb levels, higher EPO doses should be considered. Iron stores should be continuously monitored, particularly in patients receiving rHuEPO, since iron deficiency is an important problem for patients undergoing peritoneal dialysis, especially during erythropoietin therapy. Oral iron supplementation is satisfactory in the majority of patients, and iron-gluconate is absorbed better than iron-sulphate. If required, intra-venous iron bolus is safe and efficient. Continuous peritoneal dialysis treatment improves blood count more effectively compared to intermittent procedures, as hemoglobin levels are significantly higher in patients with comparable iron stores. Peritoneal dialysis is particularly efficient in improving the blood count in diabetics, since no significant difference of anemia between patients affected by diabetes mellitus and the others could be found in our study.


2019 ◽  
Author(s):  
Jose Portolés-Pérez ◽  
Beatriz Durá-Gúrpide ◽  
José Luis Merino-Rivas ◽  
Leyre Martín-Rodriguez ◽  
Covadonga Hevia-Ojanguren ◽  
...  

Abstract Background The efficacy of intravenous (IV) ferric carboxymaltose (FCM) has been demonstrated in haemodialysis and non-dialysis studies, but evidence is lacking in patients undergoing peritoneal dialysis (PD). Methods This multicentre, retrospective study evaluated the effectiveness and safety of FCM in patients on PD over 12 months. We retrospectively reviewed the electronic medical records of PD patients who initiated FCM treatment between 2014 and 2017 across seven Spanish centres. Results Ninety-one patients were included in the safety population (mean ± SD age 57.7 ± 15.0 years) and 70 in the efficacy population (mean age 50.9 ± 14.5 years). No hypersensitivity reaction, FCM discontinuation or dose adjustment due to a serious adverse event (SAE) was registered in the safety population. The most common non-SAEs reported were headache (four events), mild hypotension (three events) and hypertension (two events), among others. In the efficacy population (n = 70), 68.6% of patients achieved ferritin levels of 200–800 ng/mL, 78.4% achieved transferrin saturation (TSAT) >20%, and 62.8% achieved TSAT >20% and ferritin >200 ng/mL after 12 months of FCM initiation (P < 0.01). Haemoglobin (Hb) levels were maintained at >11 g/dL with a lower dose of darbepoetin throughout the follow-up. The sub-analysis of patients naïve to IV iron and with absolute or relative iron deficiency (n = 51) showed that 76.5% reached ferritin >200 ng/mL, 80.4% TSAT >20% and Hb increased (1.2 g/dL) after 4 months of FCM treatment (P < 0.01). Conclusion In this multicentre, retrospective, real-world study conducted in the PD population, FCM was effective, safe and easy to administer during routine clinical visits.


2016 ◽  
Vol 36 (3) ◽  
pp. 297-307 ◽  
Author(s):  
Jeffrey Perl ◽  
Simon J. Davies ◽  
Mark Lambie ◽  
Ronald L. Pisoni ◽  
Keith McCullough ◽  
...  

Background Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. Methods The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. Results A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. Conclusion The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients.


2015 ◽  
Vol 35 (2) ◽  
pp. 189-198 ◽  
Author(s):  
Dawn F. Wolfgram ◽  
Aniko Szabo ◽  
Anne M. Murray ◽  
Jeff Whittle

Background Compared with similarly aged controls, patients with end-stage renal disease (ESRD) have a higher prevalence of cognitive impairment and more rapid cognitive decline, which is not explained by traditional risk factors alone. Since previous small studies suggest an association of cognitive impairment with dialysis modality, we compared incident dementia among patients initiating hemodialysis (HD) vs peritoneal dialysis (PD) in a large national cohort. Methods This is a retrospective cohort study of incident dialysis patients in the United States from 2006 to 2008 with no diagnosis of dementia prior to beginning dialysis. We evaluated the effect of initial dialysis modality on incidence of dementia, diagnosed by Medicare claims data, adjusted for baseline demographic and clinical data from the USRDS registry. Results Our analysis included 121,623 patients, of whom 8,663 initiated dialysis on PD. The mean age of our cohort was 69.2 years. Patients who initiated PD had a lower cumulative incidence of dementia than those who initiated HD (1.0% vs 2.7%, 2.5% vs 5.3%, and 3.9% vs 7.3% at 1, 2, and 3 years, respectively). The risk of dementia for patients who started on PD was lower compared with those who started on HD, with a hazard ratio (HR) = 0.46 [0.41, 0.53], in an unadjusted model and HR 0.74 [0.64, 0.86] in a matched model. Conclusions Dialysis modality is associated with incident dementia in a cohort of older ESRD patients. This finding warrants further investigation of the effect of dialysis modality on cognitive function and evaluation for possible mechanisms.


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