Association Between Use of Antithrombotic Medication and Hematuria-Related Complications

Wallis, Christopher J.D.; Juvet, Tristan; Lee, Yuna; Matta, Rano; Herschorn, Sender; Kodama, Ronald; Kulkarni, Girish S.; Satkunasivam, Raj; Geerts, William; McLeod, Anne; Narod, Steven A.; Nam, Robert K.

doi:10.1001/jama.2017.13890

Cited by 45 publications

(43 citation statements)

References 39 publications

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“…The well-established risk of bleeding complications during NOAC therapy was indeed reflected in the signals produced by the screening. With regard to bleeding type, NOAC therapy seemed to be associated with an increased risk of especially gastrointestinal bleeding and hematuria, which corresponds well with the findings of prior studies [4,5,26]. However, the specific results may be biased by treatment choices made in patients with a bleeding event in the period leading up to NOAC initiation (i.e.…”

Section: Discussionsupporting

confidence: 85%

“…To date, most studies based on such observational data provide associations between NOAC use and specific AEs already known from the clinical trials, e.g. bleeding related AEs [3][4][5]. However, another and complementary use of observational data when exploring AEs is hypothesis-free computerized screening of large scale health care registries.…”

Section: Introductionmentioning

confidence: 99%

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Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants

et al. 2018

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MethodsUsing the nationwide Danish registries, we identified AF patients initiating dabigatran, rivaroxaban, or apixaban between 2011 and 2015 (n=50,627). Applying a symmetry analysis design, we screened for AEs of NOAC, as reflected by new drug treatments, incident diagnoses, or procedures. For signals with the lowest number needed for one additional patient to be harmed (NNTH), we evaluated whether they likely represented genuine AEs or other types of associations. Signals assessed as potential AEs were grouped into five categories for analysis of effect modification according to patient and drug characteristics. ResultsOf the identified signals, 61 were classified as potential AEs. Most signals could be categorized according to the following types of AEs: bleedings, non-bleeding gastrointestinal symptoms, mental disease, urinary tract disorders, and musculoskeletal symptoms. Older age and first-ever use of anticoagulants was associated with strengthening of all 'NOAC-adverse effect'-associations. Conversely, use of low-dose NOAC and apixaban led to attenuation of most associations. ConclusionThrough a symmetry analysis based hypothesis-free screening of large scale health care databases, we were able to confirm well-established AEs to NOAC therapy in clinical practice as well as potential AEs that deserve further investigation.3 Key Points• A hypothesis-free screening of automated health care databases generated signals of potential adverse effects to NOAC therapy. The vast majority of signals could be categorized as bleedings, non-bleeding gastrointestinal adverse effects, mental disease, urinary tract disorders, or musculoskeletal symptoms.• The risk of experiencing adverse effects seems to vary according to patient and drug characteristics such as age and NOAC dose.• The present study has generated several specific signals of potential adverse effects to NOAC therapy. These signals should be evaluated in future studies. 5 MethodsUsing a symmetry analysis design [7], we analyzed the occurrence of events (drug initiation, new diagnosis, and procedures) in a symmetrical time-window before and after initiation of a NOAC for AF. Any non-symmetrical distribution of the occurrence of these events before and after NOAC initiation might reflect effects of NOAC treatment. Data sourcesVirtually all medical care in Denmark is furnished by the national health authorities, allowing population-based register-linkage studies covering all inhabitants of Denmark [12]. We used data from three nationwide health registries. Data on drug use was retrieved from the National Prescription Registry [13] as filled prescriptions. From the National Patient Register [14] we obtained data on registered in-and outpatient diagnoses (classified according to International Classification of Diseases, 10 th Edition (ICD-10)) and procedures from non-psychiatric hospitals. Finally, the Civil Registration System[15] was used to keep track of study subjects with respect to deaths and migrations. Data were linked by using the set-up provided by Dan...

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Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants

et al. 2018

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“…Mogelijk zorgden de patiënten met DOAC voor het wat hogere percentage nabloedingen in het huidige onderzoek. Ander, grootschalig onderzoek (niet na een TURP) wijst eveneens op een relatie tussen DOAC en het optreden van een bloeding [14,15]. 5 % van de patiënten werd na de TURP opnieuw in het ziekenhuis opgenomen vanwege een secundaire bloeding.…”

Section: Discussieunclassified

Preoperative (direct) oral anticoagulants and secondary hemorrhage after TURP

2020

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Samenvatting Een transurethrale resectie van de prostaat (TURP) wordt uitgevoerd ter behandeling van een goedaardige prostaatvergroting. In dit onderzoek is nagegaan of er een relatie is tussen preoperatief gebruik van (directe) orale anticoagulantia ((D)OAC) en secundaire bloedingen na een TURP. Hiertoe zijn van alle mannen die in 2016 of 2017 in Gelre ziekenhuizen een bipolaire TURP ondergingen gegevens verzameld over preoperatief (D)OAC-gebruik, secundaire bloedingen en heropnamen tot vier weken postoperatief. Bij 15 % van de 376 geïncludeerde patiënten ontstond een secundaire bloeding, namelijk bij 24 % met preoperatief OAC-gebruik (met name DOAC) en bij 9 % zonder preoperatief OAC-gebruik (p < 0,001). Bij 5 % was heropname nodig, namelijk bij 7 % met preoperatief OAC-gebruik (met name DOAC) en bij 3 % zonder preoperatief OAC-gebruik (p = 0,10). Patiënten die een TURP ondergaan en preoperatief OAC gebruiken, in het bijzonder DOAC, hebben dus mogelijk een verhoogd risico op een secundaire bloeding. Verder onderzoek met meer patiënten is echter nodig om de resultaten te bevestigen.

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“…Microhematuria is associated with the need for medical attention, with patients presenting to the emergency department as well as undergoing hospitalization and urologic procedures. 76 It has been shown that patients taking anticoagulant drugs are more likely to develop microhematuria than those receiving antiplatelet treatment. Warfarin is associated with the highest risk of microhematuria, while dabigatran, with a higher risk of gross hematuria than clopidogrel or aspirin.…”

Section: Surgical Treatmentmentioning

confidence: 99%

Management of bleeding in patients hospitalized in the intensive cardiac care unit: expert opinion of the Association of Intensive Cardiac Care and Section of Cardiovascular Pharmacotherapy of the Polish Cardiac Society in cooperation with specialists in other fields of medicine

et al. 2019

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Association Between Use of Antithrombotic Medication and Hematuria-Related Complications

Cited by 45 publications

References 39 publications

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants

Preoperative (direct) oral anticoagulants and secondary hemorrhage after TURP

Management of bleeding in patients hospitalized in the intensive cardiac care unit: expert opinion of the Association of Intensive Cardiac Care and Section of Cardiovascular Pharmacotherapy of the Polish Cardiac Society in cooperation with specialists in other fields of medicine

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