Factors Affecting Trough Plasma Dabigatran Concentrations in Patients with Atrial Fibrillation and Chronic Kidney Disease

Скрипка, А. И.; Сычев, Д. А.; Бочков, П. О.; Шевченко, Р. В.; Крупенин, П. М.; Kogay, Veronika; Листратов, А. И.; Krainyaya, Arina; Гуринович, О. С.; Соколова, А. А.; Напалков, Д. А.; Фомин, В В

doi:10.1007/s40292-020-00373-2

Cited by 12 publications

(6 citation statements)

References 11 publications

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“…38,40 One of them reported only using validated LC-MS/MS method without further details. 37 Eight studies 34,[42][43][44][45][46][47][48] with a total of 630 patients did not provide details on the method validation, which may raise risk of bias.…”

Section: Search Results and Study Characteristicsmentioning

confidence: 99%

“…Five studies 20,26,43,52,58 with significantly skewed estimated mean and standard deviation were excluded as this estimation method is not recommended 29 . Other exclusion reasons were dosing regimens other than 110‐ or 150‐mg twice‐daily dosing, 36,37,40,41,46,51,53,55 special population 42,48 and repeated measurements reported within the same patients 50 …”

Section: Resultsmentioning

confidence: 99%

“…Five studies 20,26,43,52,58 with significantly skewed estimated mean and standard deviation were excluded as this estimation method is not recommended. 29 Other exclusion reasons were dosing regimens other than 110-or 150-mg twice-daily dosing, 36,37,40,41,46,51,53,55 special population 42,48 When dabigatran concentrations were pooled based on the methods used to measure concentrations, the pooled dabigatran concentrations were higher in the LC-MS/MS group compared to the HTI assay. The results are reported in Table 6.…”

Section: Meta-analysismentioning

confidence: 99%

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A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Tahir

Chin

et al. 2022

Brit J Clinical Pharma

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Dabigatran etexilate is an oral direct thrombin inhibitor used in preventing thromboembolism in patients with atrial fibrillation and several other conditions. Routine dabigatran concentration monitoring is not recommended in clinical practice; however, measurement of dabigatran concentration may be required in several conditions. This study aims to pool the peak and trough dabigatran concentration from real‐world studies. A systematic review was performed to identify studies that measured the peak and trough dabigatran concentrations. Observational studies reporting dabigatran peak or trough concentrations and patients' clinical characteristics of either sex, age or weight were included. Random‐effect meta‐analyses and metaregression were conducted to pool dabigatran concentrations and to identify the correlation between factors affecting dabigatran concentrations. Fifteen studies with a total of 1226 patients were included. The pooled peak dabigatran concentration was 133 ng/mL (95% CI: 113–154, I2 = 86%, n = 655), while the pooled dabigatran trough concentration was 80 ng/mL (95% CI: 69–91, I2 = 93%, n = 1010). Metaregression analyses suggested that age is significantly correlated to trough concentration, while body weight and creatinine clearance significantly correlated to peak concentration. Subgroup results revealed that dabigatran concentration when measured with liquid chromatography–tandem mass spectrometry was higher than haemoclot thrombin inhibitor assay. Several guidelines have proposed dabigatran concentrations target range and the pooled dabigatran concentrations were in line with the suggested range. Further studies to correlate dabigatran concentrations and clinical outcomes is warranted to improve the safety and efficacy monitoring of dabigatran therapy.

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Section: Search Results and Study Characteristicsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Meta-analysismentioning

confidence: 99%

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A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

Tahir

Chin

et al. 2022

Brit J Clinical Pharma

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“…С другой стороны, участие почек в выведении прямых пероральных антикоагулянтов (ППОАК) на 27-80% в зависимости от конкретного препарата так же может влиять на эффективность и безопасность указанных лекарственных средств [27]. Например, концентрация дабигатрана в плазме крови между приемами препарата является вариабельным показателем и увеличивается у пациентов с ХБП С3b стадии, особенно, в пожилом возрасте и при наличии сопутствующих заболеваний [34].…”

Section: патофизиологические основы рисков тромбозов и кровотечений unclassified

New aspects of anticoagulant therapy in atrial fibrillation in patients with renal dysfunction

2020

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Atrial fibrillation (AF) and chronic kidney disease (CKD) are common and interrelated diseases, the combination of which is associated with a poor prognosis. The efficacy and safety of direct oral anticoagulants (DOACs) used to prevent thromboembolic complications of AF may depend on renal function due to the specific pharmacokinetics of these drugs. This review considers current data on the role of kidneys in the pathogenesis of ischemic and bleeding events, methods of renal function assessment and related classification issues, as well as comparison of warfarin and DOAC therapy, in patients with AF and renal dysfunction of different stages based on the results of randomized controlled trials and actual clinical practice. DOAC use in the context of dynamic deterioration of renal function, supranormal renal function, and their effect on renal outcomes is discussed. International guidelines on anticoagulant therapy in AF and renal dysfunction were analyzed.

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“…Исходя из известных данных об ADME-процессах новых лекарственных средств, в клинических условиях в РМАНПО активно проводятся «ассоциативные» исследования: изучается влияние полиморфизмов генов CYP3A4, CYP3A5, ABCB1 (кодирует Р-гликопротеин), CES1 (кодирует карбоксиэстеразу 1 типа) на фармакокинетику, уровни равновесных концентраций прямых оральных антикоагулянтов (ингибитора IIа фактора дабигатрана, ингибиторов Xa фактора ривароксабана и апиксабана), развитие НПР (прежде всего кровотечений) у пациентов с тромбозами и высоким риском их развития (неклапанная фибрилляция предсердий, состояние после эндопротезирования) во взаимосвязи с активностью изоферментов подсемейства цитохрома Р450 3А (оценивается по отношению кортизола к 6-бетагидроксикортизолу в моче), в т. ч. в условиях почечной дисфункции и межлекарственного взаимодействия (с блокаторами медленных кальциевых каналов) и в возрастной группе старше 80 лет [9][10][11][12][13][14][15].…”

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Problems of integrating medical science, image and practical health care: focus on personalized medicine

Сычёв

2020

Fgen_Fgenom

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On the example of technologies of personalization of pharmacotherapy based on biomarkers of the processes of absorption, distribution, metabolism and excretion of drugs (ADME-processes), the methodology of the results of scientific research into the educational process within the system of continuous medical education of doctors into the real clinical practice is presented. This methodology has been developed and implemented in the Russian Medical Academy of Continuing Professional Education.

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Factors Affecting Trough Plasma Dabigatran Concentrations in Patients with Atrial Fibrillation and Chronic Kidney Disease

Cited by 12 publications

References 11 publications

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

A systematic review and meta‐analysis of dabigatran peak and trough concentration in adults

New aspects of anticoagulant therapy in atrial fibrillation in patients with renal dysfunction

Problems of integrating medical science, image and practical health care: focus on personalized medicine

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