Incidence and Predictors of Hemorrhagic Stroke in Users of Low-Dose Acetylsalicylic Acid

González‐Pérez, Antonio; Sáez, María Eugenia; Johansson, Saga; Himmelmänn, Anders; Rodrı́guez, Luis A. Garcı́a

doi:10.1016/j.jstrokecerebrovasdis.2015.06.016

Cited by 4 publications

(5 citation statements)

References 26 publications

(31 reference statements)

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“…[ 36 , 37 ] Digoxin has also been reported to increase the risk of hemorrhage stroke. [ 38 ] These results further indicate that thrombosis or hemorrhage may increase mortality and that digoxin should be carefully used in the control of the ventricular rate in elderly patients with AF.…”

Section: Discussionmentioning

confidence: 95%

Prognostic factors of clinical endpoints in elderly patients with atrial fibrillation during a 2-year follow-up in China

Wang

Wang²,

Chen³

et al. 2017

Medicine

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This study aimed to reveal the incidence of clinical endpoints in elderly patients with atrial fibrillation (AF) during a 2-year follow-up and evaluate the related prognostic factors of these endpoints.In total, 200 elderly patients with AF and 400 age- and sex-matched patients without AF were enrolled in this prospective observational cohort study. The incidence of clinical endpoints, including thromboembolism, hemorrhage, and all-cause death, during the 2-year follow-up was analyzed. Other follow-up data, including disease history, laboratory examinations, medication status, and other clinical endpoints, were collected. The prognostic factors of these clinical endpoints were then evaluated by Cox-survival analysis. In addition, the predicative role of C-reactive protein (CRP) and platelet-activating factor (PAF) on these clinical endpoints was analyzed.The incidence of clinical endpoints, including thromboembolism, hemorrhage, and all-cause death, was significantly higher in patients with AF than in those without AF (27.8% vs 9.8%, 29.4% vs 12.7%, and 28.7% vs 11.6%, respectively; all P < .001). Antithrombotic therapy significantly reduced the incidences of all-cause deaths (P < .05). Body mass index (BMI) and digoxin were prognostic risk factors of thromboembolism; age, massive hemorrhage history, and digoxin were prognostic risk factors of hemorrhage and age, renal insufficiency history, massive hemorrhage history, and digoxin were prognostic risk factors of all-cause death (P < .05). Further, both CRP and PAF were prognostic risk factors of thromboembolism and massive hemorrhage (P < .05).Age, BMI, massive hemorrhage history, and digoxin appear to be prognostic risk factors of clinical endpoints in elderly patients with AF. Appropriate drug use during follow-up may be beneficial in preventing the occurrence of clinical endpoints in elderly patients with AF.Trial registration number: ChiCTR-OCH-13003479.

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Section: Discussionmentioning

confidence: 95%

Prognostic factors of clinical endpoints in elderly patients with atrial fibrillation during a 2-year follow-up in China

Wang

Wang²,

Chen³

et al. 2017

Medicine

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“…Nonsteroidal anti-inflammatory drugs were used by one quarter of the cases compared with aspirin users. Previous research on concurrent use of NSAIDs has also not supported an increased risk for hemorrhagic stroke (Gonzalez-Perez et al, 2015; Soriano et al, 2017). The underlying mechanism for the reduced hemorrhagic stroke associated with NSAID use requires further investigation.…”

Section: Discussionmentioning

confidence: 93%

“…Aspirin (Shah et al, 2019), warfarin (Gonzalez-Perez, et al, 2015; Soriano et al, 2017), and aspirin and warfarin combined (Gulati et al, 2018; Soriano et al, 2017) are clearly associated with increased hemorrhagic stroke. A meta-analysis that included 62 cases with hemorrhagic stroke supported no difference in risk between aspirin and warfarin (Ambrosi et al, 2017).…”

Section: Discussionmentioning

confidence: 99%

Predictors of hemorrhagic stroke in older persons taking nonsteroidal anti-inflammatory drugs: Results from the Food and Drug Administration Adverse Event Reporting System

McDonald

Srisopa

2020

J Am Assoc Nurse Pract

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Background: Hemorrhagic strokes have not declined in the United States despite a decline worldwide. Purpose: To identify hemorrhagic stroke risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs), other medications associated with increased risk for hemorrhagic stroke, and diabetes, cardiovascular disease, gender, and age. Methods: A post hoc design was used to examine predictors of hemorrhagic stroke for adults of age 65 years and older from the Food and Drug Administration Adverse Events Reporting System database. The initial sample consisted of all cases reported during the third quarter of 2016 and the second quarter of 2018 with an NSAID as the primary suspect for the adverse drug event (ADE). An additional 397 cases with warfarin as the primary suspect were included in the final sample (N = 3,784) to test for bias from including only NSAID as the primary ADE suspect cases. Extracted data included the primary ADE (hemorrhagic stroke or other ADE), age, gender, primary suspect drug (NSAID or warfarin), and presence of a second NSAID, rivaroxaban, warfarin, clopidogrel, antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants), inhaled corticosteroids, diabetes, or cardiovascular medications. Logistic regression was used to predict hemorrhagic stroke. Results: Aspirin and warfarin increased the risk for hemorrhagic stroke by 3.458 and 3.059, respectively. Presence of an additional NSAIDs reduced the risk by 48%. Implications for practice: Hemorrhagic stroke risk specific to older adults may provide helpful estimates for practitioners as they weigh the risk benefit of prescribing aspirin as an antiplatelet therapy for older adults.

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“…De-identified clinical, health and socioeconomic data are available for approximately 11.1 million patients in the UK. Previous experience in clinical research : THIN data have been accessed to measure clinical outcomes in cohort and case-control studies [ 34 ] North West eHealth ( NWEH ) [ 35 ] Data access for clinical research : NWEH is a collaboration between The University of Manchester, Salford Royal Foundation Trust and Salford Clinical Commissioning Group . NWEH has developed the methodology and governance framework to implement the Salford Integrated Record , an integrated primary- and secondary-care electronic medical record, into research as part of the Salford Lung Study [ 14 ].…”

Section: Resultsmentioning

confidence: 99%

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access

Powell¹,

Bonnett

Tudur-Smith

et al. 2017

Trials

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BackgroundIn the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs.MethodsSetting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy.Participants: 98 participants have provided written consent to permit the request of routinely recorded data.Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed.ResultsSecondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful.ConclusionsRecommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN30294119. Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012.

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Incidence and Predictors of Hemorrhagic Stroke in Users of Low-Dose Acetylsalicylic Acid

Cited by 4 publications

References 26 publications

Prognostic factors of clinical endpoints in elderly patients with atrial fibrillation during a 2-year follow-up in China

Prognostic factors of clinical endpoints in elderly patients with atrial fibrillation during a 2-year follow-up in China

Predictors of hemorrhagic stroke in older persons taking nonsteroidal anti-inflammatory drugs: Results from the Food and Drug Administration Adverse Event Reporting System

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access

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