MO526REAL-WORLD EVIDENCE ON CLINICAL OUTCOMES IN NON-DIABETIC CKD

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Christoph Wanner ◽  
Johannes Schuchhardt ◽  
Chris Bauer ◽  
Stefanie Lindemann ◽  
Meike Brinker ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Kidney Failure ◽  
Time Course ◽  
Kidney Injury ◽  
Incidence Rates ◽  
Real World Evidence ◽  
Ckd Stage ◽  
The Us ◽  
Egfr Decline

Abstract Background and Aims Chronic kidney disease (CKD) represents a global public health problem, with significant morbidity and mortality due to cardiovascular disease during CKD progression and due to kidney failure. Although non-diabetic CKD accounts for up to 70% of the global CKD burden, its clinical consequences are poorly understood, and data are needed to help identify individuals at high risk of adverse outcomes. This analysis uses real-world evidence to provide insights into clinical characteristics, care and outcomes in individuals with non-diabetic CKD in routine clinical practice. Method Individual-level data from the US administrative claims database, Optum Clinformatics Data Mart, from January 1, 2008 to December 31, 2018 were analysed. Adults with non-diabetic CKD stage 3 or 4 and ≥365 days continuous insurance coverage were included and followed until insurance disenrollment, end of data availability or death. Individuals with diabetes mellitus, CKD stage 5 or end-stage kidney disease (ESKD) prior to the index date, or who experienced kidney failure (acute or unspecified), kidney transplant or dialysis in the baseline period, were excluded from the analysis. Study outcomes, captured in the database, were defined using common clinical coding systems. Primary outcomes were hospitalisation for heart failure (HHF), a kidney composite of ESKD/kidney failure/need for dialysis, and worsening of CKD stage from baseline. Individual CKD stage was assigned based on estimated glomerular filtration rate (eGFR) values (priority) or the respective International Classification of Diseases code at index and during follow-up. Further prespecified kidney outcomes included individual components of the kidney composite, acute kidney injury, and absolute and relative change in eGFR from baseline. Event-based outcomes were assessed by time-to-first-event analysis. Summary statistics for time-course analysis of metric outcomes were generated on a quarterly basis. Results In total, 504,924 of 64 million individuals in the Optum Clinformatics Data Mart satisfied the selection criteria. Over a median follow-up of 744 (interquartile range 328–1432) days, the incidence rates of primary outcomes of HHF, the kidney composite and worsening of CKD stage from baseline were 3.95, 10.33 and 4.38 events/100 patient-years (PY), respectively. The incidence rates of the components of the kidney composite outcome, namely ESKD/need for dialysis, kidney failure (acute and unspecified) and need for dialysis were 1.78, 9.53 and 0.49 events/100 PY, respectively. Kidney failure events were driven mainly by acute kidney injury, with an incidence of 8.61 events/100 PY. In individuals with at least one available eGFR value at baseline and one value during follow-up (n=295,174), the incidence rates of relative decreases in eGFR of ≥30%, ≥40% and ≥57% from baseline were 1.98, 0.97 and 0.30 events/100 PY, respectively; in this cohort, more rapid eGFR decline was associated with increased risk of HHF and the kidney composite outcome. In individuals with a baseline eGFR value and at least one follow-up eGFR value and an available urine albumin-to-creatinine ratio (n=25,824), time-course analysis of eGFR showed that eGFR decline mostly occurred in individuals with moderately-to-severely increased albuminuria (≥30 mg/g). Conclusion This analysis generates real-world evidence on clinical outcomes in a cohort of individuals with non-diabetic CKD treated in routine clinical practice in the US. Despite known limitations of claims databases (e.g. low availability of some laboratory data, limited individual follow-up time and tactical coding), individuals with moderate-to-severe non-diabetic CKD are shown to be at high risk of serious clinical outcomes. This highlights the high unmet medical need, and urgency for new treatments and targeted interventions for patients with non-diabetic CKD.

scholarly journals MO495UNDERSTANDING INTERNATIONAL VARIATION IN KIDNEY FAILURE INCIDENCE: IMPACT OF DISPARITIES IN RAAS INHIBITOR PRESCRIPTION AND BLOOD PRESSURE CONTROL

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Natalia Alencar de Pinho ◽  
Roberto Pecoits-Filho ◽  
Brian Bieber ◽  
Daniel Muenz ◽  
Antonio Lopes ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Kidney Failure ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Ckd Progression ◽  
Ckd Stage ◽  
The Us

Abstract Background and Aims Blood pressure (BP) control and renin-angiotensin-aldosterone system (RAAS) blockade are key measures to slow CKD progression, and the achievement of targets for these measures vary greatly across countries. We sought to evaluate to what extend this might explain international variations in kidney failure incidence. Method We used data from the CKD Outcomes and Practice Patterns Study (CKDopps), a cohort study of adult patients recruited from national samples of nephrology clinics. Patients with CKD G3 or G4, from Brazil (n=498), France (n=2702), Germany (n=2314), and the US (n=905) were included. Those neither with hypertension nor with albuminuria were excluded (n=103). We assessed systolic BP and RAAS inhibitor prescription at baseline, and their association with time to kidney failure, defined as an estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73m² or kidney replacement therapy initiation. Death was treated as a competing event. Cox proportional-hazards model was used to estimate cause-specific hazard ratios (cs-HR) and 95% confidence intervals (CI) for kidney failure according to country, before and after adjusting for systolic BP and RAAS inhibitor prescription, as well as demographics, and known risk factors for CKD progression. Results Median age (years) ranged from 67 in Brazil to 75 in Germany; and mean baseline eGFR (ml/min/1.73m²), from 27 in Germany to 33 in France. Prevalence of diabetes ranged from 20% in France to 36% in Brazil, and that of stage A3 albuminuria (>300 mg/g), from 31% in Brazil to 44% in the US. Mean systolic BP (mm Hg) ranged from 132 in Brazil to 143 in France, and the percentage of patients prescribed RAAS inhibitor, from 58% in the US to 81% in Germany. After median follow-up of 4.0 (2.6-5.0) years, 1897 participants progressed to kidney failure and 522 died before meeting this outcome. Two-year crude cumulative incidence of kidney failure was the lowest in France (14%), where patients were recruited at an earlier CKD stage, and similar across Germany (25%), the US (26%), and Brazil (27%); that for all-cause death, the lowest in Brazil (2.5%), followed by France (3.4%), the US (4.4%), and Germany (4.6%). Sequential adjustment for demographics and progression risk factors, in particular baseline eGFR and albuminuria, significantly reduced the gap between France and the other countries (Figure). Despite the associations of systolic BP (cs-HR 1.14, 95%CI 0.95-1.38 for 120-129; 1.18, 95%CI 0.95-1.46 for 130-139; and 1.46, 95%CI 1.23-1.74 for ≥140 versus <120 mm Hg) and RAAS inhibitor prescription (cs-HR 0.81, 95%CI 0.70-0.95 at 6 months of follow-up) with kidney failure, adjustment for these two treatment targets only marginally changed comparisons across studied countries. Conclusion In CKD patients under nephrology care, BP control and RAAS inhibitor prescription were associated with lower risk of kidney failure and substantially varied across countries. Despite this variation in practice, BP control and RAAS inhibitor prescription appear to explain little of the differences in risk of kidney failure by country.

scholarly journals Adverse clinical outcomes associated with RAAS inhibitor discontinuation: analysis of over 400 000 patients from the UK Clinical Practice Research Datalink (CPRD)

2021 ◽  
Author(s):  
Toby J L Humphrey ◽  
Glen James ◽  
Eric T Wittbrodt ◽  
Donna Zarzuela ◽  
Thomas F Hiemstra
Keyword(s):  
Heart Failure ◽  
Acute Kidney Injury ◽  
Clinical Practice ◽  
Clinical Outcomes ◽  
Kidney Injury ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Ckd Stage ◽  
First Occurrence ◽  
Baseline Characteristics

Abstract Background Users of guideline-recommended renin–angiotensin–aldosterone system (RAAS) inhibitors may experience disruptions to their treatment, e.g. due to hyperkalaemia, hypotension or acute kidney injury. The risks associated with treatment disruption have not been comprehensively assessed; therefore, we evaluated the risk of adverse clinical outcomes in RAAS inhibitor users experiencing treatment disruptions in a large population-wide database. Methods This exploratory, retrospective analysis utilized data from the UK’s Clinical Practice Research Datalink, linked to Hospital Episodes Statistics and the Office for National Statistics databases. Adults (≥18 years) with first RAAS inhibitor use (defined as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) between 1 January 2009 and 31 December 2014 were eligible for inclusion. Time to the first occurrence of adverse clinical outcomes [all-cause mortality, all-cause hospitalization, cardiac arrhythmia, heart failure hospitalization, cardiac arrest, advancement in chronic kidney disease (CKD) stage and acute kidney injury] was compared between RAAS inhibitor users with and without interruptions or cessations to treatment during follow-up. Associations between baseline characteristics and adverse clinical outcomes were also assessed. Results Among 434 027 RAAS inhibitor users, the risk of the first occurrence of all clinical outcomes, except advancement in CKD stage, was 8–75% lower in patients without interruptions or cessations versus patients with interruptions/cessations. Baseline characteristics independently associated with increased risk of clinical outcomes included increasing age, smoking, CKD, diabetes and heart failure. Conclusions These findings highlight the need for effective management of factors associated with RAAS inhibitor interruptions or cessations in patients for whom guideline-recommended RAAS inhibitor treatment is indicated.

scholarly journals 886. The Impact of the COVID-19 Pandemic on Clinical Follow-Up, Monitoring and Regimen Discontinuation for People Living with HIV in the US

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S534-S535
Author(s):  
Gerald Pierone ◽  
Jennifer S Fusco ◽  
Laurence Brunet ◽  
Cassidy Henegar ◽  
Jean A van Wyk ◽  
...  
Keyword(s):  
Viral Load ◽  
Board Member ◽  
Incidence Rates ◽  
People Living With Hiv ◽  
Open Circle ◽  
Viral Load Monitoring ◽  
The Us ◽  
Load Monitoring ◽  
Living With Hiv

Abstract Background The COVID-19 pandemic has disrupted health care services for people living with HIV (PLWH). This study aimed to compare rates of clinical visits, viral load monitoring and antiretroviral therapy (ART) regimen discontinuation among virally suppressed PLWH in the US before and during the COVID pandemic. Methods The study population consisted of ART-experienced PLWH ≥18 years of age and active in care in the OPERA cohort within 2 years prior to 31OCT2020. Virally suppressed PLWH (i.e., viral load < 200 copies/mL) were included if they switched to either dolutegravir/lamivudine or a dolutegravir- or bictegravir-based 3-drug regimen between 01MAY2019 and 30APR2020. The study periods spanned from 01MAY2019 to 28FEB2020 (pre-COVID) and 01MAR2020 to 31OCT2020 (during COVID). Incidence rates of clinical visits, viral load measurements and regimen discontinuation were estimated using univariate Poisson regression for both study periods. In-person visits comprised any scheduled or walk-in outpatient, inpatient, emergency or laboratory visit. Telehealth visits comprised any phone or video encounters. Results The study included 4806 PLWH in the pre-COVID and 4992 in the COVID period. Rates of in-person visits were reduced almost 2-fold during COVID, while telehealth visits increased almost 9-fold, resulting in an overall reduction in any visits rates from 10.07 visits per person-year (95% CI: 9.93, 10.21) pre-COVID to 7.10 (95% CI: 7.01, 7.19) during COVID [Fig 1]. Rates of viral load measurements dropped from 2.99 viral loads per person-year (95% CI: 2.92, 3.07) pre-COVID to 1.97 (95% CI: 1.92, 2.02) during COVID [Fig 2]. Regimen discontinuation rates were also reduced from 14.3 discontinuations per 100 person-years pre-COVID (95% CI: 12.7, 16.1) to 9.6 (95% CI: 8.6, 10.8) during COVID [Fig 3]. In both study periods, virologic failures were detected in < 1% of PLWH with ≥ 1 viral load. Figure 1. Incidence rates for overall, in-person, and telehealth visits during the pre-COVID (open circle) and the COVID (filled circle) study periods Incidence rates for viral load measurements during the pre-COVID (open circle) and the COVID (filled circle) study periods Incidence rates for regimen discontinuation during the pre-COVID (open circle) and the COVID (filled circle) study periods Conclusion The COVID pandemic has led to an important reduction in the frequency and type of clinical follow-up visits and viral load monitoring among virally suppressed PLWH in the US. A reduction in regimen discontinuation rates was also observed, presumably associated to less frequent follow-up. The long-term impact of the pandemic on HIV care remains uncertain. Disclosures Gerald Pierone, MD, Epividian (Board Member) Jennifer S. Fusco, BS, Epividian, inc (Employee) Laurence Brunet, PhD, Epividian, inc (Employee) Cassidy Henegar, PhD, GSK (Shareholder)ViiV Healthcare (Employee) Jean A. van Wyk, MB,ChB, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Supriya Sarkar, PhD, GSK (Shareholder)ViiV Healthcare (Employee) Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare Limited (Employee) Andrew Zolopa, MD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Michael B. Wohlfeiler, MD, Epividian, inc (Board Member)ViiV Healthcare (Research Grant or Support) Gregory Fusco, MD, MPH, Epividian, inc (Employee)

scholarly journals P0695ANALYSIS OF HOSPITALIZATION EVENTS IN NON-DIALYSIS CKD PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Marcora Mandreoli ◽  
Dino Gibertoni ◽  
Antonio Santoro
Keyword(s):  
Hospital Admissions ◽  
Laboratory Data ◽  
Kidney Injury ◽  
Vascular Diseases ◽  
Hospitalization Rate ◽  
Renal Diseases ◽  
Ckd Stage ◽  
Emilia Romagna Region ◽  
Specific Care

Abstract Background and Aims Data are limited about rates and causes of hospitalization in patients with Chronic Kidney Disease (CKD) during maintenance period. In the present study, we investigate the amount, characteristics and trends of hospital admissions in a large cohort of pre-dialysis CKD patients followed within the Emilia-Romagna Region (Italy) PIRP project. Method Patients who were enrolled in the PIRP project in the period 1.4.2004-31.12.2018 constitute the study population. The PIRP database contains clinical and laboratory data collected at each follow-up visit. Hospitalization data regarding admissions occurred during patients’ follow-up in PIRP were obtained from the regional hospital discharges database through unique individual linkage. Day-hospital admissions and hospitalizations aimed at arteriovenous fistula creation and peritoneal catheter placement were excluded. Results In almost 15 years of observation, 27,886 patients were enrolled in PIRP, mostly males (65,3%) with baseline median age of 75 years and baseline median eGFR=32.3 mL/min/1.73m2. Among them, 19,288 (69.2%) generated 72,432 hospitalizations during their follow-up in the project. The number of hospitalizations per person/year was 1.06 overall, increasing from 0.38 for stage CKD 1 to 1.93 for stage CKD 5 (Fig.1). The median length of stay was 9 days. Overall, cardio-vascular diseases were the main cause of hospitalization (30.0% of admissions), with renal diseases, tumors and respiratory diseases each accounting for over 10% of admissions, although the distribution of causes of hospitalization varies according to CKD stage (Fig.2). About one fifth of patients had one or more hospitalizations for acute kidney injury. The trend analysis revealed a steadily decreasing hospitalization rate for patients that were on CKD stage 4 and 5 at baseline, a constant hospitalization trend over time for patients who began their follow-up in stages 1 to 3a, while hospitalization rate of patients in CKD 3b stage declined after 9 years (Fig 3). Conclusion The study broadens our knowledge on the hospitalizations “consumption” by the population with CKD in the non-dialysis phase. It confirms that patients with CKD represent a vulnerable population, needing about 1 hospitalization / year / patient. The trend towards a reduction in hospitalizations during the follow-up period could be traced back to the specific care model, which encourages a more frequent management of patients in the Nephrology clinics.

Prognostic Factors and Long-Term Outcome with ANCA-Associated Kidney Vasculitis in Childhood

2021 ◽  
pp. CJN.19181220
Author(s):  
Marta Calatroni ◽  
Filippo Consonni ◽  
Marco Allinovi ◽  
Alessandra Bettiol ◽  
Natasha Jawa ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Kidney Failure ◽  
Prognostic Significance ◽  
Remission Induction ◽  
Long Term Outcome ◽  
Anca Associated Vasculitis ◽  
Kidney Involvement ◽  
Ckd Stage

Background and objectives. Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is extremely rare in children. We report the clinico-pathological features, long-term outcomes, and prognostic factors of a large paediatric cohort of patients with ANCA-associated kidney vasculitis. Design, setting, participants, and measurements. This retrospective study included 85 consecutive patients with kidney biopsy-proven ANCA-associated vasculitis followed at tertiary referral centres in Italy and Canada. Kidney biopsies were categorised as focal, crescentic, sclerotic or mixed following Berden's classification. The prognostic significance of baseline clinical, laboratory and histological findings was analysed with respect to kidney failure or chronic kidney disease (CKD) 3-5/kidney failure. Results. Fifty-three patients had microscopic polyangiitis (62%) and 32 granulomatosis with polyangiitis (38%). Rapidly progressive glomerulonephritis was the most frequent presentation (39%); one third of the patients also had nephrotic-range proteinuria. Kidney biopsies were classified as focal in 21% of the patients, crescentic in 51%, sclerotic in 15% and mixed in 13%. Remission-induction therapies included cyclophosphamide in 78% of cases. Twenty-five patients (29%) reached kidney failure. The median time to kidney failure or last follow-up was 35 months (6-89) in the whole cohort, and 73 months (24-109) among the patients who did not reach this outcome. Cases with sclerotic histology showed significantly shorter kidney survival [HR 11.80 (95% CI 2.49-55.99)] and CKD 3-5-free survival [HR 8.88 (95% CI 2.43-32.48)] as compared with focal/mixed ones. Baseline eGFR, low serum albumin, hypertension, central nervous system complications and sclerotic histology, which reflected severe kidney involvement, were associated with both kidney failure or CKD stage 3-5/kidney failure at unadjusted analysis; no independent prognostic factors emerged at multivariate analysis. Conclusions. Children with ANCA-associated kidney vasculitis often have aggressive presentation; one-third of them progress to kidney failure and usually do so early during the follow-up. A severe renal presentation is associated with the development of CKD or kidney failure.

Abstract P274: Kidney Filtration Markers and the Risk of Clinical Outcomes in Individuals With Type 2 Diabetes in the Advance Trial

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Hyunju Kim ◽  
Dan Wang ◽  
John Chalmers ◽  
Mark Woodward ◽  
Elizabeth Selvin ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Outcomes ◽  
Regression Models ◽  
Cox Regression ◽  
All Cause Mortality ◽  
Baseline Levels ◽  
Controlled Evaluation ◽  
Egfr Decline

Introduction: Creatinine-based estimated glomerular filtration rate (eGFR) is biased in the setting of obesity and other conditions. Alternative kidney filtration markers may be particularly useful in adults with diabetes, but few studies examined the risk of clinical outcomes associated with filtration markers in adults with type 2 diabetes. Objective: We evaluated whether baseline levels and change in eGFR based on creatinine (Cr), cystatin C (Cys), and B 2 -microglobulin (B2M) were associated with the risk of clinical outcomes among individuals with type 2 diabetes. Methods: In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, Cr, Cys, and B2M were measured in 7,217 participants at baseline and a random sample of 640 participants at the 1 year visit. We categorized baseline eGFR Cr , eGFR Cys , eGFR B2M , and the average across the 3 eGFR estimates (eGFR avg ) into quarters, and examined associations with major macrovascular and microvascular events together, and separately, and all-cause mortality using Cox regression models, adjusting for established risk factors. We also examined associations with continuous eGFR decline and increase (per 30%). Results: Over a median follow-up of 5 years, 1,313 combined major macrovascular (n=748) and microvascular events (n=637), and 743 deaths occurred. Lower levels of eGFR based on all three filtration markers individually and combined were associated with 1.5 to 2.2 times higher risk of combined major macrovascular and microvascular events, with similar patterns for other outcomes ( Table ). Per 30% decline in eGFR Cys and eGFR avg were associated with a >2-fold higher risk of all clinical outcomes, after additional adjustment of baseline eGFR. Conclusions: In adults with type 2 diabetes, baseline levels of eGFR based on alternative filtration markers and per 30% decline in eGFR Cys and eGFR avg were consistently associated with all clinical outcomes.

Overall Economic Burden of Total Treatment Costs in Acute Myeloid Leukemia throughout the Course of the Disease

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3614-3614 ◽  
Author(s):  
Dalia Mahmoud ◽  
Barry S. Skikne ◽  
Izabela Kucmin-Bemelmans ◽  
Cathelijne Alleman ◽  
Marja Hensen
Keyword(s):  
Economic Burden ◽  
Salvage Therapy ◽  
Myeloid Leukemia ◽  
Incidence Rates ◽  
Treatment Costs ◽  
The Us ◽  
Total Treatment ◽  
The Uk ◽  
The Cost

Abstract Abstract 3614 Background: Acute Myeloid Leukemia (AML) is a common form of leukemia in adults and often requires high resource use. About 84% of the total cost is attributed to hospital payments (Menzin 2002). The aggregate disease burden is difficult to estimate due to multiple complications and treatment courses. The standard treatment modality for AML is intensive chemotherapy with complete remission (CR) achieved in up to 60% of adults with de novo AML who are less than 70 years old (Tallman, 2005), while in the older adults CR rates occur in approximately 45% (Jabbour, 2006). For patients who relapse after CR there are a limited number of efficacious therapeutic options. These include best supportive care (BSC), additional cycles of chemotherapy and stem cell transplantation (SCT) in a minority of patients. Aim: To estimate the economic burden of the total treatment costs of AML in patients receiving therapy in the US and UK. Treatment costs are specifically assessed for induction therapy (IT), consolidation therapy (CT), for follow up during CR, and salvage therapy for relapsed or refractory disease. Methods: To identify the total costs of AML therapy, a systematic literature review was conducted of standard treatments employed during the past 5 years. Economic costs were estimated per course of treatment which included IT, CT, supportive treatment during CR, and salvage therapy including use of SCT. The total economic burden was calculated combining cost per patient with epidemiology data. Incidence rates for the US and UK and treatment outcome probabilities were calculated from the Surveillance Epidemiology and End Results (SEER), Eurostat and peer reviewed literature. Unit costs were identified using publicly available databases. Calculations were conducted for younger (<65) and older (>65) patients given differences in incidence rates identified between these groups. Costs of treatment were calculated individually for each of the following treatment stages: 1) IT (standard dose chemotherapy (SDC) 1 cycle), 2) CT- 2 cycles of chemotherapy 3) follow up after CR (costs of BSC – 6 cycles), and 4) salvage therapy for relapse refractory disease. Results: The costs associated with hospitalization are the main component in all treatment stages (induction, consolidation, and relapse) ranging from 66% to 92% of the total costs. IT plus CT accounted for 19%-91% of the total cost per patient. When combining costs per patient with incidence data, it is estimated that the total economic burden of AML treatment ranges from £13 mln for population >65 and £38 mln for the <65 in the UK and approx. $0.5 billion and $1.5$ billion respectively in US. Not surprising, the cost of transplantation was the highest of all the treatments. The financial burden after relapse is also high compared to the cost of being followed in CR (which consists primarily of the laboratory monitoring and supportive care), namely £683 for BSC, £4,097 for chemotherapy and £82,262 transplantation vs. £4,097 in CR in the UK and $2,477, $56,588 and $154,739 vs. $14,861, respectively in the US. (Table 1). Summary/Conclusions: The economic burden of AML treatment is very high. In both the UK and US, hospitalization costs are the key drivers. Findings suggest that savings to the healthcare system could be achieved by sustaining CR status for longer periods. When relapse occurs, high costs are incurred again, particularly when another round of chemotherapy is given. Therefore, besides the fact that achieving and staying in CR is important from the clinical point of view, it has an essential justification from the economic perspective when considering the costs that patients incur after relapse. It is critical to focus on developing new therapies that can prevent relapse and maintain AML patients' CR status to maximize their survival. Disclosures: Mahmoud: celgene: Employment. Skikne:Celgene: Employment, Equity Ownership. Kucmin-Bemelmans:Pharmerit BV: Employment. Alleman:Pharmerit BV: Employment. Hensen:Pharmerit BV: Employment.

scholarly journals Significance of serum FGF-23 for risk assessment of contrast-associated acute kidney injury and clinical outcomes in patients undergoing coronary angiography

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254835
Author(s):  
Shao-Sung Huang ◽  
Po-Hsun Huang ◽  
Hsin-Bang Leu ◽  
Tao-Cheng Wu ◽  
Jaw-Wen Chen ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Coronary Angiography ◽  
Clinical Outcomes ◽  
Kidney Injury ◽  
Multivariate Regression Analysis ◽  
Major Adverse Cardiovascular Events ◽  
Free Survival ◽  
Increased Risk ◽  
Fgf 23

Background Fibroblast growth factor (FGF)-23 levels rise as kidney function declines. Whether elevated FGF-23 levels are associated with an increased risk for contrast-associated acute kidney injury (CA-AKI) and major adverse cardiovascular events (MACE) in patients undergoing coronary angiography remain uncertain. Methods In total, 492 patients receiving coronary angiography were enrolled. Their serum FGF-23 levels were measured before administration of contrast media. The occurrence of CA-AKI was defined as a rise in serum creatinine of 0.5 mg/dL or a 25% increase from the baseline value within 48 h after the procedure. All patients were followed up for at least 1 year or until the occurrence of MACE including death, nonfatal myocardial infarction (MI), and ischemic stroke. Results Overall, CA-AKI occurred in 41 (8.3%) patients. During a median follow-up of 2.6 years, there were 24 deaths, 3 nonfatal MIs, and 7 ischemic strokes. Compared with those in the lowest FGF-23 tertile, individuals in the highest FGF-23 tertile had a significantly higher incidence of CA-AKI (P < 0.001) and lower incidence of MACE-free survival (P = 0.001). In multivariate regression analysis, higher FGF-23 level was found to be independently associated with a graded risk for CA-AKI (OR per doubling, 1.90; 95% CI 1.48–2.44) and MACE (HR per doubling, 1.25; 95% CI 1.02–1.52). Conclusions Elevated FGF-23 levels were associated with an increased risk for CA-AKI and future MACE among patients undergoing coronary angiography. FGF-23 may play a role in early diagnosis of CA-AKI and predicting clinical outcomes after coronary angiography.

scholarly journals 572. Antiviral Toxicities Among Pediatric Solid Organ Transplant Recipients

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S351-S351
Author(s):  
Kevin J Downes ◽  
Anna Sharova ◽  
Marina Mitrou ◽  
Molly Hayes ◽  
Despoina Galetaki ◽  
...  
Keyword(s):  
Medication Management ◽  
Organ Transplant ◽  
Kidney Injury ◽  
Solid Organ Transplant ◽  
Incidence Rates ◽  
First Year ◽  
Solid Organ ◽  
Transplant Recipients ◽  
Cmv Disease

Abstract Background Ganciclovir (GCV) and valganciclovir (VGCV) are used for prophylaxis (PPX) and treatment for CMV in pediatric solid organ transplant (SOT) recipients, but the frequency and impact of toxicities from these medications are not well described. Methods Retrospective cohort study of children undergoing SOT at Children’s Hospital of Philadelphia from Jan 2012 - Jun 2018. EMR were reviewed to identify laboratory-based toxicities between 15 days and 1 year post-transplant; medication management within 14 days of toxicity onset was recorded. Toxicities were defined as GCV or VGCV-associated if a patient was on the antiviral at toxicity onset. We defined acute kidney injury (AKI) as ≥50% change in creatinine (Cr) from 30 days prior, leukopenia as WBC &lt; 3500/µL, neutropenia as ANC &lt; 1000/µL, and thrombocytopenia as &lt; 100K/µL. Incidence rates of toxicities on PPX and treatment were compared to rates during no antiviral using univariate Poisson regression. Results 285 children received 299 SOTs: 108 liver, 91 kidney, 69 heart, 31 lung. Nearly half (46%) of toxicities during the first year after transplant occurred while on GCV or VGCV PPX or treatment, but their use accounted for only 23% of all follow-up time. Receipt of VGCV and GCV PPX and treatment were associated with significantly higher incidence rates of toxicities compared to no antiviral (Fig 1). Of 259 GCV or VGCV-associated toxicities, 44% (n=113) were leukopenia, 26% (66) neutropenia, 26% (66) AKI, and 6% (15) thrombocytopenia (Table 1). Most recipients of VGCV PPX (64%) sustained at least one toxicity while on PPX. AKI during VGCV PPX led to stopping/dose-adjusting of VGCV in 43% and of immunosuppression in 57% of cases. Neutropenia during VGCV PPX resulted in stopping/dose-adjusting of VGCV in 63%, of immunosuppression in 36%, and of TMPX/SMX PPX in 36% of cases. During VGCV PPX, 81% of AKI was stage II/III (≥100% change in Cr) and 65% of neutropenia was severe (&lt; 500/µL); 11% of both AKI (n=6) and neutropenia (n=7) during VGCV PPX resulted in hospitalization. Figure 1. Incidence Rates of Toxicities from Day 15 through 1 Year After Transplant Table 1. Antiviral Use and Toxicity 2 Weeks to 1 Year After Transplant Conclusion GCV and VGCV use was associated with significant renal and hematological toxicities in pediatric SOT recipients. While VGCV and GCV are effective at preventing CMV disease in pediatric SOT, clinicians should consider risk of toxicity when evaluating CMV prevention strategies. Disclosures Kevin J. Downes, MD, Merck, Inc. (Grant/Research Support)

scholarly journals Change in GFR over time in the Oxford Renal Cohort Study

2021 ◽  
pp. BJGP.2021.0477
Author(s):  
Jennifer A Hirst ◽  
Maarten Taal ◽  
Simon D Fraser ◽  
Jose Ordóñez-Mena ◽  
Chris O'Callaghan ◽  
...  
Keyword(s):  
Cohort Study ◽  
Kidney Function ◽  
Smoking Status ◽  
Multivariable Analysis ◽  
Adverse Outcomes ◽  
Adverse Health Outcomes ◽  
Ckd Stage ◽  
Gfr Decline ◽  
Egfr Decline

Background: Decline in kidney function can result in adverse health outcomes. The OxREN study has detailed baseline assessments from 884 participants ≥60 years. Aim: To determine the proportion of participants with decline in estimated glomerular filtration rate (eGFR), identify determinants of decline and determine proportions with chronic kidney disease (CKD) remission. Design and setting: Observational cohort study in UK primary care. Methods: Data were used from baseline and annual follow-up assessments to monitor change in kidney function. Rapid eGFR decline was defined as eGFR decrease >5 ml/min/1.73m2/year, improvement as eGFR increase >5ml/min/1.73m2/year and remission in those with CKD at baseline and eGFR>60 ml/min/1.73m2 during follow-up. Cox proportional hazard models were used to identify factors associated with eGFR decline. Results: In 686 participants with a median follow-up of 2.1 years, 164 (24%) evidenced rapid GFR decline, 185 (27%) experienced eGFR improvement and 82 of 394 (21%) meeting CKD stage 1-4 at baseline experienced remission. In the multivariable analysis, smoking status, higher systolic blood pressure and being known to have CKD at cohort entry were associated with rapid GFR decline. Those with CKD stage 3 at baseline were less likely to exhibit GFR decline compared with normal kidney function. Conclusions: This study established that 24% of people evidenced rapid GFR decline whereas 21% evidenced remission of CKD. People at risk of rapid GFR decline may benefit from closer monitoring and appropriate treatment to minimise risks of adverse outcomes, though only a small proportion meet the NICE criteria for referral to secondary care.

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