Bleeding events and activated partial thromboplastin time with dabigatran in clinical practice

Kawabata, Mihoko; Yokoyama, Yoshihiko; Sasano, Tetsuo; Tanaka, Yasuaki; Yagishita, Atsuhiko; Sugiyama, Koji; Nakamura, Tomofumi; Suzuki, Masahito; Isobe, Mitsuaki; Hirao, Kazuyuki

doi:10.1016/j.jjcc.2013.03.010

Cited by 25 publications

(19 citation statements)

References 25 publications

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“…Also, Shinoda et al 76 Conversely, bleeding can also be a problem in underdosed patients. Kawabata et al 84 collected data from 11 patients with minor bleeding events taking dabigatran and 3 of them were revealed to be underdosed. In a Japanese study, in 5 cases of symptomatic intracranial haemorrhage receiving rivaroxaban 2 of them received an inappropriately reduced dose.…”

Section: Underdosingmentioning

confidence: 99%

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

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Aims Worldwide observational studies are evidencing discordance between guidelines and real‐world practice regarding direct oral anticoagulant drug (DOAC) doses. This systematic review summarizes and evaluate DOACs use in real‐world practice. Methods This review was performed following the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines searching PubMed (MEDLINE) and Medscape databases. Results Data from 75 studies showed that most of the patients treated with DOACs for stroke prevention in atrial fibrillation received doses in accordance to the guidelines. However, a significant number of patients received off‐label doses (25–50% in most of the studies evaluated). DOAC overdosing was associated with increased all‐cause mortality and worse bleeding events while underdosing was associated with increased cardiovascular hospitalization and, particularly for apixaban, with a nearly 5‐fold increased risk of stroke. Conclusion Patients prescribed with off‐label DOAC doses did not receive the full benefit of anticoagulation and presented an increased risk of stroke, bleeding and/or adverse effects.

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Section: Underdosingmentioning

confidence: 99%

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

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“…Therefore, it is recommended that activated partial thromboplastin time (aPTT) be used as a parameter for monitoring anticoagulant activity in dabigatran‐treated patients [1,8,9]. The relationship between aPTT and dabigatran therapy has recently gained a lot of attention; however, there are limited data in Japanese patients [10–14].…”

Section: Introductionmentioning

confidence: 99%

Relationship between plasma dabigatran concentration and activated partial thromboplastin time in Japanese patients with non‐valvular atrial fibrillation

Shimomura

Nakagawa

Kondo

et al. 2014

Journal of Arrhythmia

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a b s t r a c tBackground: Activated partial thromboplastin time (aPTT) is recommended for monitoring anticoagulant activity in dabigatran-treated patients; however, there are limited data in Japanese patients. To clarify the relationship between plasma dabigatran concentration and aPTT, we analyzed plasma dabigatran concentration and aPTT at various time points following administration of oral dabigatran in a Japanese hospital. Methods: We enrolled 149 patients (316 blood samples) with non-valvular atrial fibrillation (NVAF) who were taking dabigatran. Patients had a mean age of 66.67 10.0 years (range: 35-84) and 66% were men. Plasma dabigatran concentrations and aPTT were measured using the Hemoclot s direct thrombin inhibitor assay and Thrombocheck aPTT-SLA s , respectively. Samples were classified into eight groups according to elapsed times in hours since oral administration of dabigatran.Results: Significantly higher dabigatran concentrations were observed in samples obtained from patients with low creatinine clearance (CLCr) (CLCro 50 mL/min). Dabigatran concentrations and aPTT were highest in the 4-h post-administration range. Additionally, there was a significant correlation between plasma dabigatran concentrations and aPTT (y¼ 0.063xþ32.596, r 2 ¼ 0.648, po 0.001). However, when plasma dabigatran concentrations were 200 ng/mL or higher, the correlation was lower (y¼ 0.040xþ38.034 and r 2 ¼0.180); these results were evaluated by a quadratic curve, resulting in an increased correlation (r 2 ¼0.668).Conclusions: There was a significant correlation between plasma dabigatran concentrations and aPTT. Additionally, in daily clinical practice in Japan, plasma dabigatran concentrations and aPTT reached a peak in the 4-h post administration range. Considering the pharmacokinetics of dabigatran, aPTT can be used as an index for risk screening for excess dabigatran concentrations in Japanese patients with NVAF.

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“…14 The overall lack of sex-based analysis in studies conducted to determine the safety and effectiveness of dabigatran in comparison with warfarin leaves a void for unanswered questions about the safety and effectiveness of dabigatran in these subpopulations. [15][16][17][18][19] Therefore, in this population-based study we aimed to compare sex differences in utilization patterns of dabigatran, and to investigate whether dabigatran has a differential effect in men and women, with regard to stroke, bleeding, and myocardial infarction (MI).…”

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confidence: 99%

Sex Differences in Dabigatran Use, Safety, And Effectiveness In a Population-Based Cohort of Patients With Atrial Fibrillation

Tsadok

Jackevicius

Rahme

et al. 2015

Circ: Cardiovascular Quality and Outcomes

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Background-Sex differences were observed with regard to warfarin treatment in patients with atrial fibrillation, with women having a higher risk of stroke compared with men. We aimed to compare sex differences in use, safety, and effectiveness of dabigatran. Methods and Results-We conducted a population-based cohort study of patients with atrial fibrillation using administrative data in Quebec, Canada, 1999 to 2013. Men and women who filled a prescription for dabigatran (110 and 150 mg bid) were compared with matched warfarin users with respect to their rates of stroke, bleeding, and myocardial infarction events, using propensity score analysis. The cohort comprised 31 786 women (50.4%) and 31 324 men (49.6%). Women had a higher baseline stroke risk and lower baseline bleeding risk compared with men. Women filled more prescriptions for the lower dabigatran dose compared with men (adjusted OR, 1.35; 95% confidence interval, 1.24-1.48). In multivariable analyses adjusted for propensity scores, dabigatran use was associated with a lower risk of bleeding compared with warfarin in men (P for interaction=0.008). Dabigatran was associated with a trend toward lower risk of stroke in women treated with the 150-mg dose (HR, 0.79; 95% confidence interval, 0.56-1.04), but was not associated with a difference in the risk of myocardial infarction compared with warfarin in either sex. Conclusions-In real-life practice, women are more frequently treated with low-dose dabigatran, yet a trend toward lower stroke rates in women taking high-dose dabigatran was observed. Men benefit from lower bleeding rates with dabigatran compared with warfarin. (Circ Cardiovasc Qual Outcomes. 2015;8:593-599.

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Bleeding events and activated partial thromboplastin time with dabigatran in clinical practice

Abstract: The APTT values became prolonged under dabigatran usage and exhibited a remarkable diversity. Although major bleeding did not occur unless APTT was prolonged excessively, minor bleeding arose irrespective of the APTT values even within the range of the APTT values not exceeding 80s.

Cited by 25 publications

References 25 publications

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Relationship between plasma dabigatran concentration and activated partial thromboplastin time in Japanese patients with non‐valvular atrial fibrillation

Sex Differences in Dabigatran Use, Safety, And Effectiveness In a Population-Based Cohort of Patients With Atrial Fibrillation

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