Increased Incident Ischemic Stroke Risk in Advanced Kidney Disease: A Large-Scale Real-World Data Study

Introduction: Evidence using real-world data is sparse regarding the effects of oral anticoagulants (OACs) among patients with kidney disease. The aim of this study was to investigate the effects of kidney disease on ischemic stroke (IS) or systemic embolism (SE) among patients taking OAC, using large-scale real-world data in Japan. Methods: This was a retrospective cohort study using claims data and health checkup data from health insurance associations in Japan, from January 2005 to June 2017. We enrolled 21,581 patients diagnosed with atrial fibrillation (AF). Of the total population, 11,848 (54.9%) patients were taking OAC. A Cox proportional hazards model was used to examine the effect of kidney disease on IS/SE with or without OAC. Results: During follow-up, 208 participants who were not taking OAC (mean follow-up 2.6 years) and 200 who were taking OAC (mean follow-up 3.0 years) experienced IS/SE. The % IS/SE incidence rates with and without kidney disease were 2.42/person-year and 0.63/person-year in the total population, 3.66/person-year and 0.76/person-year in the group without OAC use, and 1.52/person-year and 0.55/person-year in patients with OAC use, respectively. Hazard ratios (HRs) and 95% confidence intervals (CIs) of kidney disease for IS/SE were high, irrespective of OAC, even after adjustment: adjusted HR 2.62 (95% CI: 1.72–3.99) without OAC and adjusted HR 2.03 (95% CI: 1.20–3.44) with OAC; p = 0.193 for interaction between no OAC and OAC. Although bleeding risk was also high for kidney disease irrespective of OAC use (HR 2.93 [95% CI: 2.27–3.77] in the total population, HR 3.08 [95% CI: 2.15–4.43] in the group without OAC, and HR 2.73 [95% CI: 1.90–3.91] in the group with OAC use), net clinical benefit indicated that the benefit of OAC use exceeded the risk of bleeding: HR 4.50 (95% CI: 0.76–8.23) among those with kidney disease and HR 0.35 (95% CI: 0.04–0.66) among those without kidney disease. Conclusion: Although we found that OAC use was effective and recommended for patients with AF, advanced kidney disease is still an independent risk factor for IS/SE, even in patients taking OAC. Physicians should be aware of this risk and strictly control modifiable risk factors, regardless of OAC use.

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928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽

10.2337/db20-928-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 928-P

Author(s):

REEMA MODY ◽

MARIA YU ◽

BAL K. NEPAL ◽

MANIGE KONIG ◽

MICHAEL GRABNER

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Exenatide Qw

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Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Cancers ◽

10.3390/cancers13215550 ◽

2021 ◽

Vol 13 (21) ◽

pp. 5550

Author(s):

Morten Fink ◽

Anders Schwartz Vittrup ◽

Lars Bastholt ◽

Inge Marie Svane ◽

Marco Donia ◽

...

Keyword(s):

Adverse Events ◽

Metastatic Melanoma ◽

Real World ◽

Negative Impact ◽

Cox Proportional Hazards Model ◽

Induction Phase ◽

Discontinue Treatment ◽

Real World Data ◽

World Data ◽

Significant Difference

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

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Risk of ischemic stroke associated to analgesic drugs use: a real world data case-control study

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2018.02.473 ◽

2018 ◽

Vol 26 ◽

pp. S225

Author(s):

R. Vives ◽

A. Gomez-Lumbreras ◽

M. Fradera ◽

M. Giner-Soriano ◽

A. Garcia-Sangenis ◽

...

Keyword(s):

Ischemic Stroke ◽

Real World ◽

Case Control Study ◽

Case Control ◽

Real World Data ◽

Analgesic Drugs ◽

World Data ◽

Control Study

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PUK6 - A TARGETED REVIEW OF REAL-WORLD DATA SOURCES IN ANAEMIA OF CHRONIC KIDNEY DISEASE (CKD) IN EUROPE

Value in Health ◽

10.1016/j.jval.2018.09.2804 ◽

2018 ◽

Vol 21 ◽

pp. S475

Author(s):

S. Mokiou ◽

Z. Hakimi ◽

J. Wang-Silvanto ◽

S. Horsburgh ◽

S. Chadda

Keyword(s):

Chronic Kidney Disease ◽

Kidney Disease ◽

Real World ◽

Data Sources ◽

Real World Data ◽

World Data

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P0816CLINICAL CHARACTERISTICS AND EGFR AND UACR DISTRIBUTION ACCORDING TO THE 2012 KDIGO CKD CLASSIFICATION: A REPORT FROM THE US DISCOVER CKD COHORT

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p0816 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Juan Jose Garcia Sanchez ◽

Juan Jesus Carrero ◽

Supriya Kumar ◽

Roberto Pecoits-Filho ◽

Glen James ◽

...

Keyword(s):

Kidney Disease ◽

Real World ◽

Patient Characteristics ◽

Study Cohort ◽

Diagnostic Code ◽

Inclusion Criteria ◽

Real World Data ◽

Electronic Health Record Data ◽

World Data ◽

Co Morbidity

Abstract Background and Aims In 2012, the Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommended categorising and prognosticating chronic kidney disease (CKD) based on estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). Contemporary studies describing the prevalence and characteristics of patients with CKD categorised according KDIGO 2012 and how studies of new pharmacotherapies relate to these categories are scarce. One such new therapy class of key interest are the sodium glucose co-transporter 2 inhibitors (SGLT-2i), shown to delay the progression to renal failure and prevent cardiovascular/renal death in patients with CKD. We aimed to describe patient characteristics and the prevalence of CKD according to the 2012 KDIGO categories in a large real-world US cohort of patients with CKD (part A). We also describe a subset of the population according to the DAPA-CKD trial inclusion criteria (eGFR [25-75ml/min/1.73m2] and UACR [200-5000mg/g]) (part B). Method DISCOVER-CKD is an international observational study in patients with CKD. The DISCOVER-CKD retrospective US cohort of patients was extracted using real-world data from the integrated Limited Claims and Electronic Health Record data (IBM Health, Armonk, NY) and HealthVerity. Patients were aged ≥18 years, with ≥1 UACR measure. For part A, required first diagnostic code of CKD (Stages 3A, 3B, 4, 5, or ESRD) or two eGFR of <75 mL/min/1.73 m2 recorded at least 90 days apart and for part B, two measures of eGFR 25-75 mL/min/1.73 m2 recorded at least 90 days apart between 1st January 2008 and September 2018. Index date was diagnostic code or 2nd eGFR. The first UACR, recorded +/-12 months of index, was used to categorise patients. Descriptive analyses were used to summarise prevalence and patient characteristics. Results Of the overall study cohort (N=4330, 49.1% women, mean age 65.3±10.64 years), by KDIGO categories (part A): 85.7% (n=3601) had normal to mildly increased albuminuria, 11.0% (n=463) had moderately increased albuminuria and 3.3% (n=137) had severely increased albuminuria (Figure 1). 4.6% (n=193) fulfilled DAPA-CKD trial inclusion criteria (part B). In both populations, the most common comorbidities were hypertension (HTN, 73.0% for both) and type 2 diabetes (T2D, 57.6% and 56.2%, respectively). Anti-hypertensive drugs were frequently used (76.4% and 76.9%, respectively). Conclusion This study, utilising real-world data, adds to the scarcity of knowledge reporting the characteristics of patients with CKD in different eGFR and UACR strata according to the KDIGO 2012 definitions. We observed a trend in higher UACR in the group of patients with lower eGFR and report a high prevalence of T2D and HTN in the study population, demonstrating the high co-morbidity burden in patients, for whom new therapies may be beneficial.

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Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

Academic Pathology ◽

10.1177/2374289520968225 ◽

2020 ◽

Vol 7 ◽

pp. 237428952096822

Author(s):

Erik J. Landaas ◽

Ashley M. Eckel ◽

Jonathan L. Wright ◽

Geoffrey S. Baird ◽

Ryan N. Hansen ◽

...

Keyword(s):

Bladder Cancer ◽

Pilot Study ◽

Health Technology Assessment ◽

Technology Assessment ◽

Real World ◽

Health Technology ◽

Test System ◽

Real World Data ◽

World Data

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

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