SO053A REAL WORLD LONGITUDINAL ANALYSIS OF ANAEMIA TREATMENT PRESCRIPTIONS IN NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS, A CKDOPPS STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Marcelo Lopes ◽  
Charlotte Tu ◽  
Jarcy Zee ◽  
Bryce Foote ◽  
Murilo Guedes ◽  
...  

Abstract Background and Aims Previously lacking in the literature, this analysis aims to comprehensively describe longitudinal patterns of anaemia management, including prescriptions of ESA and iron replacement, for non-dialysis dependent chronic kidney disease (NDD-CKD) stage 3 to 5 patients under nephrologist care. Method We analysed data from a prospective cohort of 2455 NDD-CKD patients from Brazil, Germany and the US, who were not using anaemia medications (oral iron, intravenous [IV] iron, or erythropoiesis stimulating agent [ESA]) at enrolment in the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDOPPS). We excluded 26% (N=862) of patients who were using any anaemia treatment from the source population at CKDOPPS study entry; we further excluded patients with (a) missing data for demographics and/or clinical history, or (b) no laboratory and medication data during follow-up. We reported the cumulative incidence (CI) of anaemia treatment initiation, stratified by biochemical parameters and patient characteristics. For patients that started therapy, we report the frequency of medication type at the moment of initiation, as well as switches and discontinuation over 12 months. Results The CI of any anaemia treatment initiation at 12 months was 18% for the whole sample, and 54% for patients with haemoglobin (Hb) <10 g/dL. For oral iron therapy, the CI at 12 months was 26% (19%, 32%) for TSAT<20%, and 22% (17%, 28%) for ferritin <100. For IV iron use, CI at 12 months was 6% (3%, 11%) for patients with TSAT<20% and 4% (2%, 7%) for patients with ferritin <100ng/mL. For ESA use, the CI at 12 months was 38% (29%, 47%) for patients with Hb <10 g/dL, and 11% (8%, 14%) for Hb 10 to <12 g/dL. Oral iron alone was the overwhelming first treatment option in the US (67%) and Brazil (56%); in Germany, a higher prevalence of ESAs (38%) and IV iron use (15%) was noted. Anaemia medication switches and discontinuation patterns, over 12 months, are outlined in the figure. The majority patients starting anaemia treatment were no longer on therapy one year later in Brazil (54%) and the US (51%); discontinuation of treatment was much lower in Germany (22%). Conclusion Anaemia treatment is initiated in a limited number of NDD-CKD patients with clinical signs that would indicate to do so, and many patients discontinue treatment, for reasons yet to be clarified. Although haemoglobin was the main factor associated with prescriptions, only about half of patients with Hb<10g/dL received any anaemia medication during a year. Oral iron was the treatment option most often prescribed, however given to only a quarter of iron deficient patients. We noticed country differences in the patterns of anaemia prescription and treatment discontinuation, over time, that could be due to regional policy and physician-led CKD anaemia management inequalities. These results provide longitudinal data supporting the concept that anaemia is sub-optimally managed among patients with NDD CKD in the real-world setting.

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Marcelo Barreto Lopes ◽  
Charlotte Tu ◽  
Jarcy Zee ◽  
Murilo Guedes ◽  
Ronald L. Pisoni ◽  
...  

AbstractPreviously lacking in the literature, we describe longitudinal patterns of anemia prescriptions for non-dialysis-dependent chronic kidney disease (NDD-CKD) patients under nephrologist care. We analyzed data from 2818 Stage 3-5 NDD-CKD patients from Brazil, Germany, and the US, naïve to anemia medications (oral iron, intravenous [IV] iron, or erythropoiesis stimulating agent [ESA]) at enrollment in the CKDopps. We report the cumulative incidence function (CIF) of medication initiation stratified by baseline characteristics. Even in patients with hemoglobin (Hb) < 10 g/dL, the CIF at 12 months for any anemia medication was 40%, and 28% for ESAs. Patients with TSAT < 20% had a CIF of 26% and 6% for oral and IV iron, respectively. Heart failure was associated with earlier initiation of anemia medications. IV iron was prescribed to < 10% of patients with iron deficiency. Only 40% of patients with Hb < 10 g/dL received any anemia medication within a year. Discontinuation of anemia treatment was very common. Anemia treatment is initiated in a limited number of NDD-CKD patients, even in those with guideline-based indications to treat. Hemoglobin trajectory and a history of heart failure appear to guide treatment start. These results support the concept that anemia is sub-optimally managed among NDD-CKD patients in the real-world setting.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3748-3748
Author(s):  
Anat Gafter-Gvili ◽  
Benaya Rozen-Zvi ◽  
Mical Paul ◽  
Leonard Leibovici ◽  
Gafter Uzi ◽  
...  

Abstract Background: There is confounding data regarding the best method of iron supplementation in chronic kidney disease (CKD), without a consistent approach in clinical practice. Objectives: To evaluate the efficacy and safety of intravenous (IV) iron versus oral iron in patients treated for anemia of CKD. Methods: Systematic review and meta-analysis of randomized controlled trials comparing IV iron preparation with oral iron preparation for the treatment of anemia in patients with CKD (stage III, IV and V). The Cochrane Library, MEDLINE, conference proceedings and references were searched until 2007. Primary outcomes: absolute hemoglobin (Hb) level or change in Hb level from baseline at two months or at end of study; all-cause mortality. Secondary outcomes: need for renal replacement therapy (RRT) in predialysis patient and adverse events. Weighted mean differences (WMD) for outcomes with continuous variables and relative risks (RR) for dichotomous outcomes with 95% confidence intervals (CI) were estimated and pooled. Results: Our search yielded 11 trials which compared IV iron preparations (iron sucrose, iron gluconate or iron dextran) to oral iron. Compared to oral iron, there was a significant rise in Hb level in the IV iron treated hemodialysis patients (WMD 1.17; 95%CI 0.19–2.15, fig). Significant heterogeneity was observed due to different baseline Hb values and baseline iron status, different dosages of oral iron, and different dosages of erythropoiesis stimulating agents (ESA). For predialysis patients, there was a small but significant difference in the Hb level favoring the IV iron group (WMD 0.28; 95% CI 0.15–0.4, fig). For both groups effect estimates were not influenced by ESA administration. In predialysis patients, there was no significant difference in the risk for requiring RRT during the trial between the different groups (RR 0.63; 95%CI 0.25–1.65). Data on all-cause mortality were sparse (RR 0.54; 95%CI 0.09–3.13, 3 trials) and there was no difference in adverse events (RR 0.9; 95%CI 0.65–1.24) between the IV and oral treated patients. However, discontinuations of treatment were more common (RR 3.27; 95%CI 1.15–9.26) for the IV iron treated patients. Conclusions: Our review demonstrates that dialysis patients treated with IV iron have better Hb response than patients treated with oral iron. For predialysis patients, this effect is very small. IV iron should be preferred in the treatment of anemia in dialysis patients. In predialysis patients the slight advantage in Hb response should be weighed against the inconvenience and cost of IV iron treatment.


2020 ◽  
Vol 55 (2) ◽  
pp. 222-229 ◽  
Author(s):  
Adonice Khoury ◽  
Kaley A. Pagan ◽  
Michelle Z. Farland

Objective: To review the pharmacology, efficacy, and safety of ferric maltol (FM), an oral iron formulation, for iron deficiency anemia (IDA). Data Sources: A MEDLINE/PubMed and EMBASE (January 1, 1985, to June 19, 2020) literature search was performed using the terms ferric maltol, accrufer, feraccru, iron maltol, ferric trimaltol, iron deficiency, iron deficiency anemia, inflammatory bowel disease, and chronic kidney disease. Additional data sources included prescribing information, abstracts, and the National Institutes of Health Clinical Trials Registry. Study Selection/Data Extraction: English language literature evaluating FM pharmacology, pharmacokinetics, efficacy, or safety in the treatment of IDA were reviewed. Data Synthesis: FM is a ferric, non–salt-based oral iron formulation demonstrating improved tolerance in patients with previous intolerance to other iron formulations. Phase 3 trials demonstrated significant improvements in anemia and serum iron parameters in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Common adverse effects were gastrointestinal intolerance. Relevance to Patient Care and Clinical Practice: FM is an effective and well-tolerated alternative to oral iron salts for patients with IBD or CKD and IDA. Emerging data suggest that FM is noninferior to intravenous (IV) ferric carboxymaltose in patients with IBD and IDA. Prior to selecting FM over IV iron products, consideration should be given to time to normalization of Hb, ease of administration, cost, and tolerability. Conclusion: FM is a relatively safe, effective oral iron therapy that may be better tolerated than other oral iron formulations. FM may be an effective alternative to IV iron in patients with IBD.


2011 ◽  
Vol 51 (183) ◽  
Author(s):  
L Adhikary ◽  
S Acharya

Introduction: Anemia is the most common finding in chronic kidney disease patients. Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron. Both oral and intravenous irons have their own advantage and disadvantage, and the efficacy is also different. The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy, an erythropoiesis stimulating agents for increment of haemoglobin. Methods: This is a prospective study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathmandu Medical College Teaching Hospital from April 2010 to April 2011. Patients having a haemoglobin level of < 11 g/dl, transferrin saturation (TSAT) < 25%, ferritin < 300ng/ml and who were on erythropoietin therapy were allocated alternately into two groups to receive oral iron (iron fumarate) or IV iron (iv sucrose). Haemoglobin was measured after 30 days of therapy. Results: A significant increase in haemoglobin levels was observed in both groups. But the mean haemoglobin increment was more in the IV iron group than in the oral iron group. Sixty percent 60% of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20% of the oral iron group had this increase. Conclusions: Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients. Keywords: anemia; chronic kidney disease; iron.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Vaitsiakhovich ◽  
C I Coleman ◽  
F Kleinjung ◽  
S Kloss ◽  
B Vardar ◽  
...  

Abstract Background Anticoagulation therapy with vitamin K antagonists (e.g. warfarin) has recently been shown to contribute to the accelerated vascular calcification and worsening of renal function. Therefore, it is compelling to investigate the impact of different oral anticoagulants (OACs) on kidney function in non-valvular atrial fibrillation (NVAF) patients. Common co-morbidities in these patients are chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM), which might be presented at the OAC therapy initiation. Purpose The overall objective of the CALLIPER study was to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in NVAF patients with renal dysfunction in real-world setting. In particular, we evaluated the risk of worsening of renal function in NVAF patients with CKD stage 3 and 4 at baseline (1 year prior to the cohort entry). Additionally, a sub-group analysis of patients with T2DM was performed. We defined worsening of renal function as progression to CKD stage 5, kidney failure or need for dialysis. Methods Individual level data of warfarin- and rivaroxaban-naïve NVAF patients from the MarketScan database for the years 2012 through 2017 were used. Patients with moderate-to-severe CKD (stage 3 and 4) were included in the study cohort and were followed until progression to CKD 5, kidney failure or dialysis, OAC discontinuation/switch, insurance disenrollment or end of data availability. A comparative analysis evaluating the hazard ratios (HRs) with the corresponding 95% confidence intervals (CIs) under warfarin or rivaroxaban treatment was performed using Cox regression. A stabilized inverse probability of treatment weighting was used to adjust for imbalances in baseline patient characteristics. Results We identified 5,906 warfarin- and 1,466 rivaroxaban-naïve patients with NVAF and CKD stage 3 and 4, of which 60% were male, median (25–75% range) age=79 (71- 84) years, CHADS2 score=2.67 (2.00- 3.50), CHA2DS2-VASc score=4.43 (3.40–5.62), modified HAS-BLED score=3.00 (2.40 - 3.65). T2DM was present in more than 50% of patients (Table), namely, in 3,160 warfarin- and 746 rivaroxaban-users. Hazard ratios and 95% CI for worsening of renal function were evaluated at 0.53 (0.35; 0.78) in the main cohort and 0.50 (0.30; 0.83) in the T2DM sub-group, meaning that rivaroxaban was associated with a significant 47% and 50% risk reduction of this outcome in NVAF patients with CKD stage 3 and 4 with and without T2DM, respectively. Conclusion The reduced dose of rivaroxaban has appeared to lower significantly the risk of worsening of renal function versus warfarin in NVAF patients with CKD stage 3 and 4 present at the OAC therapy initiation. The conclusion holds true for the patients with the co-morbid T2DM. This evidence was generated by the CALLIPER study using one of the largest US administrative claims database. Acknowledgement/Funding CI Coleman has received research grants from Bayer AG


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Sungdam Han ◽  
Minkook Son ◽  
Byungjin Choi ◽  
ChulHyoung Park ◽  
Dong Ho Shin ◽  
...  

Chronic kidney disease–mineral bone disorder (CKD-MBD) is the most common complication in CKD patients. Although there is a consensus on treatment guidelines for CKD-MBD, it remains uncertain whether these treatment recommendations reflect actual practice. Therefore, the aim of this study was to investigate the CKD-MBD medication trend in real-world practice. This was a retrospective and observational study using a 12-year period database transformed into a common data model from three tertiary university hospitals. Study populations were subjects initially diagnosed as CKD. The date of diagnosis was designated as the index date. New patients were categorized year to year from 2008 to 2019 with a fixed observation period of 365 days to check the prescription of CKD-MBD medications including calcium-containing phosphate binder, noncalcium-containing phosphate binder, aluminium hydroxide, vitamin D receptor activator (VDRA), and cinacalcet. The numbers of CKD patients in the three hospitals were 7555, 2424, and 5351, respectively. The proportion for patients with CKD-MBD medication prescription decreased yearly regardless of hospital and CKD stage ( p for trend < 0.05). The use of aluminium hydroxide disappeared steadily while the use of VDRA increased annually in all settings. Despite these changes in prescription patterns, the mean value for CKD-MBD-related serologic markers was almost within target range. The proportion of the population within the target value was not significantly changed. Irrespective of hospital and CKD stage, similar trends of prescription for CKD-MBD medications were observed in real-world practice. Further research with a distributed network study may be helpful to understand medication trends in CKD-MBD treatment.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1198.3-1198
Author(s):  
J. Southern ◽  
M. Chakravorty ◽  
L. H. Lee

Background:Common forms of intravenous bisphosphonate used at the Royal Derby Hospital are zoledronic acid and ibandronic acid for a variety of indications. In the treatment of osteoporosis, zoledronic acid is preferred due to its convenience of once-yearly dosing; compared to ibandronic acid which is given three-monthly. Zoledronic acid is contraindicated in patients with an estimated glomerular filtration rate (eGFR) of less than 35 due to nephrotoxicity concerns. Ibandronic acid, however, is generally offered with an eGFR of 30 or over and is perceived to be a safer choice in more advanced chronic kidney disease. The potential of extending the use of ibandronic acid to patients with lower eGFR is being explored. However, there is a paucity of real world data and this study will therefore seek to affirm the safety profile in those on treatment.Objectives:Establish the safety profile of IV ibandronic acid with regards to worsening renal function or significant hypocalcaemia injury in the context of reduced renal clearance.Methods:The details of patients receiving IV ibandronic acid at Royal Derby Hospital were retrieved from the osteoporosis department register in September 2019. Data was collected anonymously from records using the electronic prescribing and pathology hospital database, together with electronic letters. The first three pre-infusion serum adjusted calcium levels, vitamin D, creatinine and eGFR were recorded. In addition, results from initiation to present were screened for any episodes of hypocalcaemia, acute kidney injury (AKI) or significant decline in renal function.Results:Treatment duration ranged from 6 months to 6 years. Female:male ratio was 9:1 and the average age was 75 years (range 50-90). Baseline eGFR ranged from 27 to over 60; 3 patients had eGFR≥60, 2 had eGFR 27 while remaining patients (75%) had eGFR 30-59. All patients received a standard 3mg infusion on each occasion. The most common rationale cited for ibandronic acid choice as opposed to zoledonic acid was reduced creatinine clearance or eGFR. Three patients (15%) developed one or more episodes of mild hypocalcaemia (lowest 2.01 mmol/l). No episodes of hypocalcaemia were identified in the first three pre-infusion levels. Four patients (25%) had a decline in eGFR by more than 5 ml/min/1.73m2but there was no definitive causal link with ibandronic acid and was most commonly felt to be related to their underlying renal disease. Three patients (15%) had at least one episode of AKI since commencing treatment, each explained by an intercurrent illness. Serum Vitamin D levels were measured pre-infusion in 92% of cases.Conclusion:This study reaffirms the safety profile of ibandronic acid use in renal function as low as CKD Stage 3b (≥30ml/min/1.73m2). No episodes of AKI or sustained decline in renal function were causally linked to ibandronic acid.References:Royal Derby Hospital Proposed Clinical Guideline (2019) – Use of ibandronic acid in CKD 4 at reduced dosage.Disclosure of Interests:None declared


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Basma Sultan ◽  
Hamdy Omar ◽  
Housseini Ahmed ◽  
Mahmoud Elprince ◽  
Osama Anter adly ◽  
...  

Abstract Background and Aims Vascular calcification (VC) plays a major role in cardiovascular disease (CVD), which is one of the main causes of mortality in patients with chronic kidney disease (CKD). The study aims at early detection of breast arterial calcification (BAC) in different stages of CKD (stage 2, 3& 4) patients as an indicator of systemic VC. Method A case control study was conducted targeting CKD women, aged 18- 60 years old. The sample was divided into 3 groups; A,B,C (representing stage 2, 3 & 4 of CKD) from women who attended nephrology and Internal medicine clinics and admitted in inpatient ward in Suez Canal University Hospital. A 4th group (D) was formed as a control group and included women with normal kidney functions (each group (A, B, C, D) include 22 women). The selected participants were subjected to history taking, mammogram to detect BAC and biochemical assessment of lipid profile, Serum creatinine (Cr), Mg, P, Ca, PTH and FGF23. Results Our study detected presence of BAC in about 81.8% of hypertensive stage 4 CKD patients compared with 50% in stage 3 CKD, also in the majority of stage 4 CKD patients who had abnormal lipid profile parameters and electrolyte disturbance. Most of the variables had statistical significance regarding the presence of BAC. Conclusion Although it is difficult to determine the definite stage at which the risk of VC begins but in our study, it began late in stage 2 CKD, gradually increased prevalence through stage 3 and became significantly higher in stage 4. These results suggest that preventive strategies may need to begin as early as stage 2 CKD.


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