Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study

Singh, Sonal; Nautiyal, Amit; Belk, Kathy

doi:10.1007/s40256-019-00360-6

Cited by 21 publications

(13 citation statements)

References 29 publications

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“…However, the use of claims data remains an important source when investigating hospital outcomes and utilization. 17,18 Despite these limitations, this study provides further evidence of the effect of comorbidities on in-hospital outcomes related to the novel coronavirus epidemic.…”

Section: Limitationsmentioning

confidence: 96%

Outcomes of Hospitalized COVID-19 Patients by Risk Factors: Results from a United States Hospital Claims Database

Mallow

Belk

Topmiller

et al. 2020

JHEOR

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Background/Objective: The primary objective was to quantify the role of the number of Centers of Disease Control and Prevention (CDC) risk factors on in-hospital mortality. The secondary objective was to assess the associated hospital length of stay (LOS), intensive care unit (ICU) bed utilization, and ICU LOS with the number of CDC risk factors. Methods: A retrospective cohort study consisting of all hospitalizations with a confirmed COVID-19 diagnosis discharged between March 15, 2020 and April 30, 2020 was conducted. Data was obtained from 276 acute care hospitals across the United States. Cohorts were identified based upon the number of the CDC COVID-19 risk factors. Multivariable regression modeling was performed to assess outcomes and utilization. The odds ratio (OR) and incidence rate ratio (IRR) were reported. Results: Compared with patients with no CDC risk factors, patients with risk factors were significantly more likely to die during the hospitalization: One risk factor (OR 2.08, 95% CI, 1.60–2.70; P < 0.001), two risk factors (OR 2.63, 95% CI, 2.00–3.47; P < 0.001), and three or more risk factors (OR 3.49, 95% CI, 2.53–4.80; P < 0.001). The presence of CDC risk factors was associated with increased ICU utilization, longer ICU LOS, and longer hospital LOS compared to those with no risk factors. Patients with hypertension (OR 0.77, 95% CI, 0.70–0.86; P < 0.001) and those administered statins were less likely to die (OR 0.54, 95% CI, 0.49–0.60; P < 0.001). Conclusions: Quantifying the role of CDC risk factors upon admission may improve risk stratification and identification of patients who may require closer monitoring and more intensive treatment.

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Section: Limitationsmentioning

confidence: 96%

Outcomes of Hospitalized COVID-19 Patients by Risk Factors: Results from a United States Hospital Claims Database

Mallow

Belk

Topmiller

et al. 2020

JHEOR

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“…[77][78][79] Although the product has been on the market for more than 3 years, only a small case series and four large studies evaluated its safety and efficacy in a real-world setting. [80][81][82][83][84] No specific dabigatran monitoring is currently recommended before reversal or during follow-up according to the prescribing information as approved by the regulatory authorities. 77,78 DOAC Reversal Agents and the Laboratory…”

Section: Idarucizumabmentioning

confidence: 99%

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Adcock²,

et al. 2021

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In 2018, the International Council for Standardization in Hematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alpha. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author’s personal experience/expert opinion and (3) good laboratory practice.

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“…Among 676 articles identified from the initial literature search, 22 studies were eligible and included in the analysis ( 1 , 2 , 5 – 24 ) ( Supplementary Figure 1 ). Sixteen studies provided individual patient data of 53 patients with ICH ( 6 – 8 , 10 , 12 , 13 , 15 – 24 ), whereas six case series reported results on, overall, 394 patients ( 1 , 2 , 5 , 9 , 11 , 14 ). Two studies ( 1 , 24 ) included patient data that have been previously reported ( 7 , 8 ).…”

Section: Resultsmentioning

confidence: 99%

“…A small number of patients did not allow for firm conclusions. On the other hand, a relatively high number of reported case series and case reports were published in the following years (1,2,(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24).…”

Section: Introductionmentioning

confidence: 99%

Dabigatran Reversal With Idarucizumab and In-Hospital Mortality in Intracranial Hemorrhage: A Systematic Review of Real-Life Data From Case Reports and Case Series

et al. 2021

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Background: Intracranial hemorrhage is a severe and possibly fatal consequence of anticoagulation therapy. Idarucizumab is used in dabigatran-treated patients suffering from intracranial hemorrhage (ICH) to reverse the anticoagulant effect of dabigatran. Systematic review of real-life mortality in these patients is missing.Objectives: A review of all published dabigatran-related ICH cases treated with idarucizumab was performed. We aimed to estimate in-hospital mortality rate in these patients.Method: We searched PubMed and Scopus for all published cases of ICH in idarucizumab/dabigatran-treated patients until May 15, 2021. The assessed outcome was in-hospital mortality.Results: We identified six eligible studies (case series) with 386 patients and 54 single case reports. In-hospital mortality rate was 11.4% in the case series and 9.7% in the case reports.Conclusions: Our analysis provides clinically relevant quantitative data regarding in-hospital mortality in idarucizumab/dabigatran-treated patients with ICH, which is estimated to be 9.7–11.4%.

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Real World Outcomes Associated with Idarucizumab: Population-Based Retrospective Cohort Study

Cited by 21 publications

References 29 publications

Outcomes of Hospitalized COVID-19 Patients by Risk Factors: Results from a United States Hospital Claims Database

Outcomes of Hospitalized COVID-19 Patients by Risk Factors: Results from a United States Hospital Claims Database

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Dabigatran Reversal With Idarucizumab and In-Hospital Mortality in Intracranial Hemorrhage: A Systematic Review of Real-Life Data From Case Reports and Case Series

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