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1.
Age Ageing ; 53(5)2024 May 01.
Article En | MEDLINE | ID: mdl-38706390

BACKGROUND: Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. AIMS: This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. METHODS: This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. RESULTS: From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. CONCLUSIONS: Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).


Ferric Compounds , Gastrointestinal Hemorrhage , Hemoglobins , Maltose , Maltose/analogs & derivatives , Quality of Life , Humans , Ferric Compounds/adverse effects , Ferric Compounds/administration & dosage , Ferric Compounds/therapeutic use , Male , Maltose/administration & dosage , Maltose/adverse effects , Maltose/therapeutic use , Female , Aged , Hemoglobins/metabolism , Hemoglobins/analysis , Gastrointestinal Hemorrhage/drug therapy , Aged, 80 and over , Double-Blind Method , Treatment Outcome , Prospective Studies , Hematinics/adverse effects , Hematinics/administration & dosage , Hematinics/therapeutic use , France , Injections, Intravenous , Age Factors
2.
Expert Rev Hematol ; 17(6): 255-260, 2024 Jun.
Article En | MEDLINE | ID: mdl-38753522

BACKGROUND: To date, there is limited evidence on patients utilizing both voxelotor and darbepoetin alfa and its impact on hemoglobin levels. The objective is to evaluate the effect of voxelotor and darbepoetin alfa on hemoglobin levels in patients with SCD. RESEARCH DESIGN AND METHODS: This was a retrospective chart review study that assessed the primary independent variable as the utilization of either voxelotor alone, darbepoetin alfa alone, or the concurrent administration of voxelotor and darbepoetin alfa. Descriptive statistics were utilized to obtain the mean standard deviation for numerical variables and proportions for categorical variables. RESULTS: A total of 23 participants were included in this study. When comparing baseline to 2 months and 3 months, participants on voxelotor alone experienced a 3% decrease and a 6.6% increase in hemoglobin, darbepoetin alfa alone group a 4.3% decrease and a 0.6% increase in hemoglobin and voxelotor and darbepoetin group a 4.4% decrease and a 0.5% decrease in hemoglobin levels. Fifty percent of the participants in the voxelotor group and 6 (66.7%) participants in the voxelotor plus darbepoetin alfa group experienced adverse drug events. CONCLUSIONS: Voxelotor resulted in a clinically significant difference in the percent change of hemoglobin from baseline to 3 months.


Anemia, Sickle Cell , Darbepoetin alfa , Erythropoietin , Hemoglobins , Humans , Darbepoetin alfa/therapeutic use , Darbepoetin alfa/administration & dosage , Male , Erythropoietin/therapeutic use , Erythropoietin/analogs & derivatives , Female , Retrospective Studies , Anemia, Sickle Cell/complications , Anemia, Sickle Cell/drug therapy , Anemia, Sickle Cell/blood , Hemoglobins/analysis , Adult , Hematinics/therapeutic use , Middle Aged , Treatment Outcome , Adolescent , Young Adult , Benzaldehydes/therapeutic use , Benzaldehydes/administration & dosage , Benzaldehydes/pharmacology , Pyrazines , Pyrazoles
3.
J Nephrol ; 37(3): 753-767, 2024 Apr.
Article En | MEDLINE | ID: mdl-38705934

Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are new drugs developed for the treatment of anemia associated with chronic kidney disease (CKD). This class of drugs stimulates endogenous erythropoietin production and, at the same time, improves iron absorption and mobilization of iron stores (less evident with daprodustat, vadadustat and enarodustat). Several studies have been published in the last few years showing that these agents are not inferior to standard therapy in correcting anemia associated with CKD. The efficacy of HIF-PHIs is coupled with a safety profile comparable to that of standard erythropoiesis stimulating agent (ESA) treatment. However, studies with HIF-PHIs were not long enough to definitively exclude the impact of new drugs on adverse events, such as cancer, death and possibly cardiovascular events, that usually occur after a long follow-up period. Kidney Disease: Improving Global Outcomes (KDIGO) recently reported the conclusions of the Controversies Conference on HIF-PHIs held in 2021. The goal of the present position paper endorsed by the Italian Society of Nephrology is to better adapt the conclusions of the latest KDIGO Conference on HIF-PHIs to the Italian context by reviewing the efficacy and safety of HIF-PHIs as well as their use in subpopulations of interest as emerged from more recent publications not discussed during the KDIGO Conference.


Anemia , Hypoxia-Inducible Factor-Proline Dioxygenases , Nephrology , Renal Insufficiency, Chronic , Humans , Renal Insufficiency, Chronic/complications , Anemia/drug therapy , Anemia/etiology , Nephrology/standards , Hypoxia-Inducible Factor-Proline Dioxygenases/antagonists & inhibitors , Consensus , Hematinics/therapeutic use , Italy , Prolyl-Hydroxylase Inhibitors/therapeutic use , Societies, Medical
5.
Clin Pharmacol Ther ; 116(1): 217-224, 2024 Jul.
Article En | MEDLINE | ID: mdl-38629679

Both short-acting (epoetin alfa or beta) and long-acting (darbepoetin alfa or PEG-epoetin) erythropoiesis-stimulating agents (ESAs) are commonly prescribed for patients with kidney failure undergoing maintenance hemodialysis. We compared the risks of major adverse cardiovascular events (MACE) and of all-cause mortality associated with receipt of short- vs. long-acting ESAs. This retrospective cohort analysis included Medicare hemodialysis beneficiaries aged ≥ 18 years in the United States Renal Data System from January 2015 to December 2017. We included adults who survived > 90 days after initiating hemodialysis and received either short- or long-acting ESAs. Outcomes were MACE (first occurrence of stroke, acute myocardial infarction, or cardiovascular-related mortality) and all-cause mortality. After stabilized inverse probability of treatment weighting, Cox proportional hazards regression models were used to estimate the hazard ratio (HR) and 95% confidence interval (CI) for each outcome. Of 68,607 patients (mean age: 65 years, 45% females), 33,658 (49%) received long-acting ESAs and 34,949 (51%) received short-acting ESAs. There was no difference in the risk of MACE associated with receipt of short- vs. long-acting ESAs (HR: 1.02 (95% CI: 0.98-1.08)). However, long-acting (vs. short-acting) ESA receipt was associated with a lower risk of all-cause mortality (HR: 0.91 (95% CI: 0.87-0.96)). Compared with short-acting ESAs, long-acting ESAs were associated with a lower risk of all-cause mortality, with no difference in the risk of MACE. Future studies with a longer follow-up are needed to confirm these findings.


Darbepoetin alfa , Hematinics , Renal Dialysis , Humans , Renal Dialysis/adverse effects , Hematinics/adverse effects , Hematinics/therapeutic use , Hematinics/administration & dosage , Female , Male , Retrospective Studies , Aged , Middle Aged , Darbepoetin alfa/therapeutic use , Darbepoetin alfa/adverse effects , Darbepoetin alfa/administration & dosage , United States/epidemiology , Cardiovascular Diseases/mortality , Epoetin Alfa/therapeutic use , Epoetin Alfa/adverse effects , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/mortality , Kidney Failure, Chronic/complications , Anemia/drug therapy , Medicare , Delayed-Action Preparations , Aged, 80 and over , Erythropoietin , Recombinant Proteins
7.
Korean J Intern Med ; 39(3): 488-500, 2024 May.
Article En | MEDLINE | ID: mdl-38649158

BACKGROUND/AIMS: Roxadustat, an oral medication for treating renal anemia, is a hypoxia-inducible factor prolyl hydroxylase inhibitor used for regulating iron metabolism and promoting erythropoiesis. To investigate the efficacy and safety of roxadustat in patients undergoing peritoneal dialysis (PD) with erythropoietin hyporesponsiveness. METHODS: Single-center, retrospective study, 81 PD patients (with erythropoietin hyporesponsiveness) were divided into the roxadustat group (n = 61) and erythropoiesis-stimulating agents (ESAs) group (n = 20). Hemoglobin (Hb), total cholesterol, intact parathyroid hormone (iPTH), brain natriuretic peptide (BNP), related indicators of cardiac function and high-sensitivity C-reactive protein (hs-CRP) were collected. Additionally, adverse events were also recorded. The follow-up period was 16 weeks. RESULTS: The two groups exhibited similar baseline demographic and clinical characteristics. At baseline, the roxadustat group had a mean Hb level of 89.8 ± 18.9 g/L, while the ESAs group had a mean Hb level of 95.2 ± 16.0 g/L. By week 16, the Hb levels had increased to 118 ± 19.8 g/L (p < 0.05) in the roxadustat group and 101 ± 19.3 g/L (p > 0.05) in the ESAs group. The efficacy of roxadustat in improving anemia was not influenced by baseline levels of hs-CRP and iPTH. Cholesterol was decreased in the roxadustat group without statin use. An increase in left ventricular ejection fraction and stabilization of BNP were observed in the roxadustat group. CONCLUSION: For PD patients with erythropoietin hyporesponsiveness, roxadustat can significantly improve renal anemia. The efficacy of roxadustat in improving renal anemia was not affected by baseline levels of hs-CRP0 and iPTH.


Anemia , Erythropoietin , Glycine , Hematinics , Hemoglobins , Isoquinolines , Peritoneal Dialysis , Humans , Male , Retrospective Studies , Female , Middle Aged , Anemia/drug therapy , Anemia/etiology , Anemia/blood , Erythropoietin/therapeutic use , Erythropoietin/adverse effects , Treatment Outcome , Glycine/analogs & derivatives , Glycine/therapeutic use , Glycine/adverse effects , Aged , Isoquinolines/therapeutic use , Isoquinolines/adverse effects , Peritoneal Dialysis/adverse effects , Hematinics/therapeutic use , Hematinics/adverse effects , Hemoglobins/metabolism , Adult , Time Factors , Biomarkers/blood , Prolyl-Hydroxylase Inhibitors/therapeutic use , Prolyl-Hydroxylase Inhibitors/adverse effects
8.
Int J Artif Organs ; 47(4): 260-268, 2024 Apr.
Article En | MEDLINE | ID: mdl-38456311

BACKGROUND: Middle uremic toxins (MUTs) can cause anemia and erythropoietin hyporesponsiveness. Theranova dialyzers may improve anemia management by removing MUTs. Hence, the impact of Theranova dialyzers on erythropoietin responsiveness was studied. METHODS: This exploratory single-center prospective observational study, encompassing 50 patients undergoing dialysis with either the Theranova-400 or FX80 membrane for 6 months, involved monthly tracking of hemoglobin levels, weight-adjusted erythropoiesis-stimulating agent (w-ESA) dosing, and erythropoietin resistance index (ERI), with ESA treatment decisions guided by a proprietary algorithm. RESULTS: The groups were similar in terms of demographics and baseline laboratory test results. The median hemoglobin levels, w-ESA and ERI, were found to be similar between FX80 and Theranova-400 groups at both baseline (11.06 vs 10.57, p = 0.808; 92.3 vs 105.2, p = 0.838; 8.1 vs 10.48, p = 0.876) and the end of the study (11.43 vs 11.03, p = 0.076; 48.7 vs 71.5; 4.48 vs 6.41, p = 0.310), respectively. There was a trend toward lower w-ESA and ERI at the end of the study compared to baseline in both groups, but the difference was non-significant. CONCLUSIONS: Based on this study of 50 patients undergoing high-flux dialysis with near-target hemoglobin levels, switching to Theranova 400 dialyzers compared to FX80 dialyzers did not show statistically significant differences in maintaining hemoglobin levels, reducing ESA dose, or lowering ERI. The non-randomized design and small sample size limit the study's power to detect true differences. Larger, randomized trials are needed to confirm findings and definitively assess Theranova 400's benefits.


Anemia , Hematinics , Hemoglobins , Renal Dialysis , Humans , Renal Dialysis/adverse effects , Male , Female , Prospective Studies , Anemia/blood , Anemia/drug therapy , Anemia/diagnosis , Anemia/etiology , Anemia/therapy , Middle Aged , Hematinics/therapeutic use , Hematinics/administration & dosage , Hemoglobins/metabolism , Aged , Erythropoietin/therapeutic use , Membranes, Artificial , Treatment Outcome , Adult
9.
Expert Opin Biol Ther ; 24(4): 233-241, 2024 Apr.
Article En | MEDLINE | ID: mdl-38555469

INTRODUCTION: In patients with myelodysplastic syndromes (MDS), anemia is prevalent affecting 80%-85% of low-risk (LR-MDS) patients, with 40% eventually requiring red blood cell (RBC) transfusions. Except forlenalidomide, exclusively approved for those with deletion of chromosome 5q,erythropoiesis-stimulating agents (ESAs) are the primary treatment choice for low-risk patients. Those unresponsive to ESAs face limited alternatives, eventually necessitating long-term RBC transfusions, leading to secondary iron overload and adversely affecting quality of life (QoL). AREA COVERED: Luspatercept is a pioneering erythroid maturation agent. It received approval by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for treating adults experiencing transfusion-dependent anemia associated with LR-MDS or ß-thalassemia. Recently, the FDA approved luspatercept as first- line therapy in patients with very low- to intermediate-risk MDS who require RBC transfusions and have not previously received ESAs. This review summarizes the historical impact of luspatercept intreating LR-MDS unresponsive to ESAs and illustrates its potential benefit asfrontline therapy in MDS and its employment in patients with myelofibrosis-induced anemia. EXPERT OPINION: Luspatercept has revolutionized the therapeutic paradigm of LR-MDS, for which there was a limited therapeutic arsenal, especially in the setting of patients who did not respond or fail after ESA treatment.


Activin Receptors, Type II , Hematinics , Immunoglobulin Fc Fragments , Myelodysplastic Syndromes , Recombinant Fusion Proteins , Humans , Myelodysplastic Syndromes/drug therapy , Immunoglobulin Fc Fragments/therapeutic use , Immunoglobulin Fc Fragments/adverse effects , Hematinics/therapeutic use , Hematinics/adverse effects , Recombinant Fusion Proteins/therapeutic use , Recombinant Fusion Proteins/adverse effects , Activin Receptors, Type II/therapeutic use , Anemia/drug therapy , Erythrocyte Transfusion , Quality of Life
10.
Med Clin (Barc) ; 162(10): e43-e51, 2024 05 31.
Article En, Es | MEDLINE | ID: mdl-38433073

OBJECTIVE: Anemia is a common condition in end-stage renal disease (ESRD) patients. Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in these patients. However, concerns have been raised regarding their potential effects on blood pressure. This systematic review and meta-analysis aim to investigate the relationship between ESAs and changes in systolic and diastolic blood pressure in hemodialysis patients. METHOD: This study is a systematic review and meta-analysis based on clinical trial studies published in various databases, including Web of Science, Cochrane Library, Science Direct, PubMed, Embase, Scopus, and Google Scholar, between 1980 and the end of 2022. We evaluated the quality of articles using the Jadad scale checklist and analyzed the data using Stata 15 software. RESULTS: Our meta-analysis included 34 clinical trial studies. The results showed a significant increase in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) after the consumption of ESAs compared to before consumption. The mean difference in SBP was 4.84mmHg (95% CI: 2.74-6.94; p-value<0.001) and in DBP was 4.69mmHg (95% CI: 2.67-6.71; p-value<0.001). No publication bias was observed. Our meta-regression analysis showed that sample size, quality assessment score, and geographical location of the study were significant factors related to observed heterogenicity in to mean difference of SBP (p-value≤0.20). For DBP, the sample size, quality assessment score and follow-up duration were significant variables (p-value≤0.20). CONCLUSION: Based on the findings of our study, it appears that receiving ESAs is associated with a significant increase in both SBP and DBP in hemodialysis patients, with an increase of about 5mmHg.


Anemia , Blood Pressure , Hematinics , Kidney Failure, Chronic , Renal Dialysis , Humans , Hematinics/therapeutic use , Blood Pressure/drug effects , Anemia/drug therapy , Anemia/etiology , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/complications , Clinical Trials as Topic , Diastole/drug effects , Systole
11.
Clin Exp Nephrol ; 28(5): 391-403, 2024 May.
Article En | MEDLINE | ID: mdl-38530490

BACKGROUND: Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor developed for treating anemia in chronic kidney disease (CKD). The purpose of this post-hoc analysis was to investigate the factors affecting the responsiveness to vadadustat in anemia patients with nondialysis-dependent (NDD) or hemodialysis-dependent (HDD) CKD in two Japanese phase 3 studies. METHODS: Of 151 and 162 patients enrolled in NDD-CKD and HDD-CKD studies, 136 and 140 patients, respectively, were included and divided into subgroups for the analysis. To assess vadadustat responsiveness, the resistance index was defined as the mean body weight-adjusted dose of vadadustat (mg/kg) at weeks 20-24 divided by the mean hemoglobin (g/dL) at weeks 20-24. Multivariate analysis was performed to identify the variables affecting the resistance index. RESULTS: Independent factors identified as determinants for better response to vadadustat were as follows: high baseline hemoglobin, low baseline eGFR, high week-20-24 ferritin, and CKD not caused by autoimmune disease/glomerulonephritis/vasculitis in NDD-CKD; and male sex, high baseline C-reactive protein, and low baseline erythropoiesis-stimulating agent resistance index (ERI) in HDD-CKD. CONCLUSIONS: In this post-hoc analysis, several factors were identified as affecting the response to vadadustat. These results may provide useful information leading to an appropriate dose modification for vadadustat. CLINICAL TRIAL REGISTRATION: NCT03329196 (MT-6548-J01) and NCT03439137 (MT-6548-J03).


Anemia , Glycine , Hemoglobins , Picolinic Acids , Renal Insufficiency, Chronic , Aged , Female , Humans , Male , Middle Aged , Anemia/drug therapy , Anemia/etiology , Double-Blind Method , East Asian People , Ferritins/blood , Glomerular Filtration Rate , Glycine/analogs & derivatives , Glycine/therapeutic use , Hematinics/therapeutic use , Hemoglobins/metabolism , Hemoglobins/analysis , Hypoxia-Inducible Factor-Proline Dioxygenases/antagonists & inhibitors , Japan , Prolyl-Hydroxylase Inhibitors/therapeutic use , Renal Dialysis , Renal Insufficiency, Chronic/complications , Treatment Outcome
12.
Sci Rep ; 14(1): 6556, 2024 03 19.
Article En | MEDLINE | ID: mdl-38503801

Anemia is common in critically ill patients undergoing continuous renal replacement therapy (CRRT). We investigated the impact of anemia requiring red blood cell (RBC) transfusion or erythropoiesis-stimulating agents (ESAs) on patient outcomes after hospital discharge in critically ill patients with acute kidney injury (AKI) requiring CRRT. In this retrospective cohort study using the Health Insurance Review and Assessment database of South Korea, 10,923 adult patients who received CRRT for 3 days or more between 2010 and 2019 and discharged alive were included. Anemia was defined as the need for RBC transfusion or ESAs. Outcomes included cardiovascular events (CVEs) and all-cause mortality after discharge. The anemia group showed a tendency to be older with more females and had more comorbidities compared to the control group. Anemia was not associated with an increased risk of CVEs (adjusted hazard ratio [aHR]: 1.05; 95% confidence interval [CI]: 0.85-1.29), but was associated with an increased risk of all-cause mortality (aHR: 1.41; 95% CI 1.30-1.53). For critically ill patients with AKI requiring CRRT, anemia, defined as requirement for RBC transfusion or ESAs, may increase the long-term risk of all-cause mortality.


Acute Kidney Injury , Anemia , Cardiovascular Diseases , Continuous Renal Replacement Therapy , Hematinics , Adult , Female , Humans , Retrospective Studies , Erythropoiesis , Critical Illness , Hematinics/therapeutic use , Anemia/complications , Anemia/drug therapy , Acute Kidney Injury/therapy
13.
Clin Exp Nephrol ; 28(7): 636-646, 2024 Jul.
Article En | MEDLINE | ID: mdl-38402503

BACKGROUND: Iron deficiency anemia (IDA) increases levels of C-terminal fibroblast growth factor 23 (cFGF23) and platelet count (PLT), each of which is associated with cardiovascular events. Therefore, we hypothesized that iron replacement with ferric citrate hydrate (FC) would decrease cFGF23 levels and PLT in patients with IDA. METHODS: In a randomized, open-label, multicenter, 24-week clinical trial, patients with non-dialysis-dependent chronic kidney disease (CKD) and non-CKD complicated by IDA (8.0 ≤ hemoglobin < 11.0 g/dL; and serum ferritin < 50 ng/mL [CKD]; < 12 ng/mL [non-CKD]) were randomized 1:1 to FC-low (500 mg: approximately 120 mg elemental iron/day) or FC-high (1000 mg: approximately 240 mg elemental iron/day). If sufficient iron replacement had been achieved after week 8, further treatment was discontinued. RESULTS: Seventy-three patients were allocated to FC-low (CKD n = 21, non-CKD n = 15) and FC-high (CKD n = 21, non-CKD n = 16). Regardless of CKD status, FC increased serum ferritin and transferrin saturation, did not change intact FGF23 or serum phosphorus, but decreased cFGF23. In FC-low group, median changes in cFGF23 from baseline to week 8 were -58.00 RU/mL in CKD and -725.00 RU/mL in non-CKD; in FC-high group, the median changes were -66.00 RU/mL in CKD and -649.50 RU/mL in non-CKD. By week 8, FC treatment normalized PLT in all patients with high PLT at baseline (>35.2 × 104/µL; FC-low: 1 CKD, 8 non-CKD; FC-high: 3 CKD, 8 non-CKD). CONCLUSION: Regardless of CKD status, iron replacement with FC decreased elevated cFGF23 levels and normalized elevated PLT in patients with IDA. CLINICAL TRIAL REGISTRATION NUMBER: jRCT2080223943.


Anemia, Iron-Deficiency , Ferric Compounds , Fibroblast Growth Factor-23 , Fibroblast Growth Factors , Renal Insufficiency, Chronic , Humans , Fibroblast Growth Factors/blood , Ferric Compounds/therapeutic use , Ferric Compounds/administration & dosage , Male , Female , Renal Insufficiency, Chronic/blood , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy , Anemia, Iron-Deficiency/drug therapy , Anemia, Iron-Deficiency/blood , Middle Aged , Aged , Platelet Count , Blood Platelets/drug effects , Blood Platelets/metabolism , Ferritins/blood , Hematinics/therapeutic use , Treatment Outcome , Adult
14.
Nutrients ; 16(4)2024 Feb 13.
Article En | MEDLINE | ID: mdl-38398842

Since zinc is involved in many aspects of the hematopoietic process, zinc supplementation can reduce erythropoiesis-stimulating agents (ESAs) in patients undergoing hemodialysis. However, it remains unclear whether hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs) have similar reduction effects. HIF-PHI stabilizes HIF, which promotes hematopoiesis, although HIF-1α levels are downregulated by zinc. This study aimed to investigate the effect of zinc supplementation on the hematopoietic effect of HIF-PHI in patients undergoing hemodialysis. Thirty patients undergoing maintenance hemodialysis who underwent periods of treatment with roxadustat or darbepoetin alfa during the past 3 years were retrospectively observed. Participants who underwent periods with and without zinc supplementation were selected, with nine treated with darbepoetin alfa and nine treated with roxadustat. Similarly to the ESA responsiveness index (ERI), the hematopoietic effect of zinc supplementation was determined by the HIF-PHI responsiveness index (HRI), which was calculated by dividing the HIF-PHI dose (mg/week) by the patient's dry weight (kg) and hemoglobin level (g/L). Zinc supplementation significantly increased ERI (p < 0.05), but no significant change was observed (p = 0.931) in HRI. Although zinc supplementation did not significantly affect HRI, adequate zinc supplementation is required to alleviate concerns such as vascular calcification and increased serum copper during the use of HIF-PHI.


Anemia , Hematinics , Prolyl-Hydroxylase Inhibitors , Renal Insufficiency, Chronic , Humans , Hematinics/pharmacology , Hematinics/therapeutic use , Anemia/drug therapy , Prolyl-Hydroxylase Inhibitors/pharmacology , Prolyl-Hydroxylase Inhibitors/therapeutic use , Zinc/pharmacology , Zinc/therapeutic use , Erythropoiesis , Prolyl Hydroxylases/pharmacology , Renal Insufficiency, Chronic/drug therapy , Darbepoetin alfa/pharmacology , Darbepoetin alfa/therapeutic use , Retrospective Studies , Glycine/pharmacology , Dietary Supplements
15.
BMC Nephrol ; 25(1): 47, 2024 Feb 05.
Article En | MEDLINE | ID: mdl-38311719

BACKGROUND: Chronic inflammation, reflected by an increased blood C-reactive protein (CRP) level, is common in patients with chronic kidney disease (CKD) and is involved in the development of renal anemia. This systematic review aims to investigate the impacts of CRP on the efficacy of hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs) in the treatment of renal anemia in patients with CKD. METHODS: We conducted a comprehensive search of electronic databases including Pubmed, Web of Science, Embase, Cochrane Library, CNKI, Wanfang, and the International Clinical Trials Registry Platform (ICTRP), from their inception to May 19, 2022. We systematically reviewed evidence from randomized controlled trials using HIF-PHIs for renal anemia treatment. The mean difference (MD) in changes in hemoglobin concentration (∆Hb) before and after treatment served as the meta-analysis outcome, utilizing a random-effects model. We compared groups with CRP levels greater than or equal to the upper limit of normal (ULN) and less than the ULN. Additionally, further analysis was conducted in the CRP ≥ ULN group comparing HIF-PHIs and erythropoiesis-stimulating agents (ESA). RESULTS: A total of 7 studies from 6 publications were included in the analysis. In the comparison between the CRP ≥ ULN group and the CRP < ULN group, 524 patients from 4 studies were incorporated into the analysis. All patients received roxadustat as the primary intervention. The pooled results revealed no significant difference in ΔHb between patients with CRP ≥ ULN and CRP < ULN at baseline (Mean Difference: 0.00, 95% Confidence Interval: -0.32 to 0.33, P = 0.99). Moreover, within the CRP ≥ ULN group, three studies involving 1399 patients compared the efficacy of roxadustat and erythropoiesis-stimulating agents (ESAs). The results indicated no significant difference in ΔHb between patients treated with ESAs and HIF-PHIs (Mean Difference: 0.24, 95% Confidence Interval: -0.08 to 0.56, P = 0.14). In terms of medication dosage, an increase in ESA dose over time was observed across various studies, particularly evident in the CRP ≥ ULN group, while the dose of roxadustat remains constant over time and is not influenced by the baseline levels of CRP. CONCLUSIONS: Our systematic review demonstrates that roxadustat exhibits similar efficacy across different CRP levels. Moreover, within the CRP ≥ ULN group, roxadustat can maintain efficacy comparable to ESA without the necessity for dose escalation. TRIAL REGISTRATION: CRD42023396704.


Anemia , Hematinics , Isoquinolines , Renal Insufficiency, Chronic , Humans , Anemia/drug therapy , Anemia/etiology , C-Reactive Protein , Chronic Disease , Glycine/analogs & derivatives , Hematinics/therapeutic use , Isoquinolines/therapeutic use , Randomized Controlled Trials as Topic , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy
16.
Blood Purif ; 53(5): 405-417, 2024.
Article En | MEDLINE | ID: mdl-38382484

INTRODUCTION: The Anemia Control Model (ACM) is a certified medical device suggesting the optimal ESA and iron dosage for patients on hemodialysis. We sought to assess the effectiveness and safety of ACM in a large cohort of hemodialysis patients. METHODS: This is a retrospective study of dialysis patients treated in NephroCare centers between June 1, 2013 and December 31, 2019. We compared patients treated according to ACM suggestions and patients treated in clinics where ACM was not activated. We stratified patients belonging to the reference group by historical target achievement rates in their referral centers (tier 1: <70%; tier 2: 70-80%; tier 3: >80%). Groups were matched by propensity score. RESULTS: After matching, we obtained four groups with 85,512 patient-months each. ACM had 18% higher target achievement rate, 63% smaller inappropriate ESA administration rate, and 59% smaller severe anemia risk compared to Tier 1 centers (all p < 0.01). The corresponding risk ratios for ACM compared to Tier 2 centers were 1.08 (95% CI: 1.08-1.09), 0.49 (95% CI: 0.47-0.51), and 0.64 (95% CI: 0.61-0.68); for ACM compared to Tier 3 centers, 1.01 (95% CI: 1.01-1.02), 0.66 (95% CI: 0.63-0.69), and 0.94 (95% CI: 0.88-1.00), respectively. ACM was associated with statistically significant reductions in ESA dose administration. CONCLUSION: ACM was associated with increased hemoglobin target achievement rate, decreased inappropriate ESA usage and a decreased incidence of severe anemia among patients treated according to ACM suggestion.


Anemia , Erythropoietin , Hematinics , Humans , Renal Dialysis/adverse effects , Hematinics/therapeutic use , Hematinics/adverse effects , Retrospective Studies , Anemia/drug therapy , Anemia/etiology , Erythropoietin/therapeutic use , Erythropoietin/adverse effects , Hemoglobins/analysis
18.
Support Care Cancer ; 32(2): 113, 2024 Jan 19.
Article En | MEDLINE | ID: mdl-38240843

PURPOSE: Anemia in cancer should be diagnosed and treated according to guideline recommendations. The implementation of ESMO and German guidelines and their effect on anemia correction was analyzed. METHODS: This retrospective epidemiological study, representative for Germany, analyzed data on anemia management of cancer patients with anemia ≥ grade 2. The Guideline Adherence Score (GLAD) for diagnosis (GLAD-D) and therapy (GLAD-T) was defined as follows: 2 points for complete, 1 point for partial, 0 point for no adherence. RESULTS: Data were analyzed for 1046 patients. Hb levels at diagnosis of anemia were 8-10 g/dL in 899 (85.9%) patients, 7-8 g/dL in 92 (8.7%), and < 7 g/dL (5.0%) in 52. Transferrin saturation was determined in 19% of patients. Four hundred fifty-six patients received RBC (43.6%), 198 (18.9%) iron replacement, 106 (10.1%) ESA, and 60 (5.7%) vitamin B12 replacement. 60.6% of patients receiving iron replacement were treated intravenously and 39.4% were treated orally. Two hundred eighty-eight (36.6%) of 785 patients receiving transfusions had no guideline-directed indication. GLAD-D was 2 in 310 patients (29.6%), 1 in 168 (16.1%), and 0 in 568 (54.3%). GLAD-T was 2 in 270 patients (25.8%), 1 in 320 patients (30.6%), and 0 in 456 patients (43.6%). Higher GLAD-D significantly correlated with higher GLAD-T (τB = 0.176, p < 0.001). GLAD-T 2 was significantly associated with greater Hb increase than GLAD-T 0/1 (p < 0.001) at 28 days (10.2 vs. 9.7 g/dL) and at 2 months (10.4 vs. 9.9 g/dL). CONCLUSIONS: Anemia assessment is inadequate, transfusion rates too high, and iron and ESA therapy too infrequent. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05190263, date: 2022-01-13.


Anemia , Hematinics , Neoplasms , Humans , Anemia/diagnosis , Anemia/epidemiology , Anemia/etiology , Hematinics/therapeutic use , Hemoglobins , Iron , Neoplasms/complications , Neoplasms/therapy , Retrospective Studies , Practice Guidelines as Topic
19.
Anesthesiol Clin ; 42(1): 65-73, 2024 Mar.
Article En | MEDLINE | ID: mdl-38278593

Anemia is the most common modifiable risk factor for postoperative morbidity and mortality. Early identification and optimal management are key to restore iron stores and ensure its resolution before surgery. Several therapies have been proposed to treat anemia in the perioperative period, such as iron supplementation and erythropoiesis-stimulating agents, though it remains unclear which is the most optimal to improve clinical outcomes. This article summarizes the most updated evidence on perioperative management of anemia and denotes differences among the international guidelines to reflect the conflicting evidence in this field and the need for further research in specific areas.


Anemia , Hematinics , Humans , Anemia/therapy , Iron/therapeutic use , Hematinics/therapeutic use , Risk Factors , Postoperative Period
20.
Ren Fail ; 46(1): 2290922, 2024 Dec.
Article En | MEDLINE | ID: mdl-38234178

Anemia is a common complication of chronic kidney disease with major option treatment of erythropoiesis-stimulating agents (ESAs). This study aimed to investigate the influencing factors of erythropoietin resistance index (ERI) and its association with mortality in maintenance hemodialysis (MHD) patients. Patients enrolled from China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5 were included. ERI was calculated as follows: ESA (IU/week)/weight (kg, post-dialysis)/hemoglobin level (g/dL). The Cox regression model was used to analyze the influencing factors on survival outcomes. Stepwise multivariate logistic regression was used to identify the related risk factors, and subgroup analyses were performed. A total of 1270 MHD subjects (687 males and 583 females) were included, with an average age of 60 (49.0, 71.0) years. All subjects were divided into two groups by the median ERI of 14.03. Multivariate logistic regression showed that dialysis vintage (OR 0.957, 95% CI: 0.929-0.986), white blood cells (OR 0.900, 95% CI: 0.844-0.960), high flux dialyzer use (OR 0.866, 95% CI: 0.755-0.993), body mass index (OR 0.860, 95% CI: 0.828-0.892), males (OR 0.708, 95% CI: 0.625-0.801), and albumin (OR 0.512, 95% CI: 0.389-0.673) had a negative association with high ERI baseline (all p < 0.05). There were 176 (13.9%) deaths in total including 89 cardiac/vascular deaths during follow-up. Cox regression analysis showed that ERI was positively associated with all-cause mortality, especially in some subgroups. ERI was associated with increased all-cause mortality in MHD patients, indicating the possibility of death prediction by ERI. Patients with high ERI warrant more attention.


Anemia , Erythropoietin , Hematinics , Kidney Failure, Chronic , Female , Humans , Male , Middle Aged , Anemia/etiology , Epoetin Alfa , Erythropoietin/therapeutic use , Hematinics/therapeutic use , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Renal Dialysis/adverse effects , Aged
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