Real-world 2-year outcome of atrial fibrillation treatment with dabigatran, apixaban, and rivaroxaban in patients with and without chronic kidney disease

Godino, Cosmo; Melillo, Francesco; Rubino, Francesca; Arrigoni, Luca; Cappelletti, Alberto; Mazzone, Patrizio; Mattiello, Paolo; Bella, Paolo Della; Colombo, Antonio; Salerno, Anna; Cera, Michela; Margonato, Alberto; investigators, INSigHT registry

doi:10.1007/s11739-019-02100-9

Cited by 24 publications

(12 citation statements)

References 40 publications

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“…This study presents the first data on tolvaptan use in Australia outside of a clinical trial setting and provides key insights into the real-world use of this treatment in patients with ADPKD. The real-world tolerability of tolvaptan was similar to that seen in the pivotal trials [ 6 , 7 ] and is similar to other medications used in the treatment of chronic kidney disease, such as anti-hypertensives [ 14 – 16 ]. Real world data on treatment persistence and tolerability is important given the differences between the tolvaptan clinical trial entry criteria and those eligible for reimbursed treatment in Australia under Pharmaceutical Benefits Scheme (PBS) criteria.…”

Section: Discussionsupporting

confidence: 53%

Treatment persistence to tolvaptan in patients with autosomal dominant polycystic kidney disease: a secondary use of data analysis of patients in the IMADJIN® dataset

et al. 2021

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Background Tolvaptan is the only available disease-modifying treatment for autosomal dominant polycystic kidney disease (ADPKD). Prior to October 2020 access to tolvaptan in Australia was restricted by a controlled monitoring and distribution program called IMADJIN®. Focusing on hepatic safety, the IMADJIN® program collected real-world data on patients with ADPKD. A retrospective, secondary data analysis of the IMADJIN® dataset was undertaken to determine the time to all-cause discontinuation of tolvaptan in Australia. Methods Demographic and treatment data from 17 September 2018 to 30 September 2020 were extracted from the IMADJIN® dataset. Treatment persistence was analyzed using Kaplan-Meier methods, and Cox’s proportional hazard models were used to analyze differences in treatment persistence by age, sex and location. Results Four hundred seventy-nine patients with ADPKD were included in the analysis. After a median follow-up of 12.0 months (95% confidence interval [CI] 2.6, 23.4), the Kaplan-Meier estimation of 12-month persistence was 76.7% (95% CI 72.2, 80.5%). 114 (23.8%) patients discontinued treatment; sex, state, and remoteness did not significantly affect treatment persistence. Patients in the youngest tertile were more likely to discontinue compared to older ages (p = 0.049). Reasons for discontinuation included: aquaretic tolerability (4.2%), hepatic adverse events (abnormal liver function tests) (2.1%), disease progression (1.5%), and acute kidney injury (0.2%). Patients with a lack of aquaretic tolerance had shorter time to discontinuation. Hepatic toxicity events were initially observed 3 months after tolvaptan initiation and were less prevalent over time. Conclusions Persistence to tolvaptan in the real-world IMADJIN® dataset was 76%. Discontinuation due to hepatic events was low. Prescribers should take extra care when initiating treatment in younger patients as they are more likely to discontinue tolvaptan compared to older individuals. Nevertheless, the precise reason for this observation remains to be elucidated.

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Section: Discussionsupporting

confidence: 53%

Treatment persistence to tolvaptan in patients with autosomal dominant polycystic kidney disease: a secondary use of data analysis of patients in the IMADJIN® dataset

et al. 2021

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“…У пациентов с ХБП более высокая частота тромбоэмболических событий наблюдалась в группе ривароксабана, в то время как низкая доза дабигатрана (110 мг 2 раза/сут.) показала превышение числа тромбоэмболических событий [28].…”

Section: антикоагуляция при фп и хбп I-iii стадийunclassified

“…Однако в европейских рекомендациях и аннотации апиксабана указывается IV стадия ХБП. Не случайно в метаанализах Chokesuwattanaskul R, et al [13] и Godino C, et al [28] апиксабан был наиболее часто используемым ПОАК при всех стадиях ХБП, что отражает доверие врачей и пациентов к выбору ПОАК при данном сочетании болезней.…”

Section: антикоагуляция при тбп (Iv и V стадии хбп)unclassified

Specifics of anticoagulation in combination with atrial fibrillation and chronic kidney disease

Загидуллин

Davtyan

2021

Russ J Cardiol

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Due to the population aging and the accumulation of concomitant diseases, the prevalence of atrial fibrillation (AF) as the most common arrhythmia is increasing. On the other hand, 14% of the population has chronic kidney disease (CKD). These conditions are often combined with each other causing a prothrombogenic effect, which significantly increase the number of unfavorable outcomes such as thromboembolism, stroke, myocardial infarction and cardiovascular death. This is especially true for the last stages of CKD, the so-called end-stage renal disease with a glomerular filtration rate <29 ml/min/1,73 m2. Previously, the vitamin K antagonist warfarin was the central drug for anticoagulant therapy of AF + CKD combination, but in the last decade, direct oral anticoagulants became widely used. This article discusses the evidence base for using each of the anticoagulants in patients with AF+CKD combination compared with warfarin, including depending on the severity of glomerular filtration rate decrease.

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“…Преимущества отдельных ППОАК, исходя из имеющихся данных, установить довольно сложно. В небольшом одноцентровом исследовании среди пациентов с КлКр 15-59/мин (n=219, 11% с КлКр <30 мл/ мин) при сравнении отдельных ППОАК между собой наблюдалось увеличение риска тромбоэмболических событий (ОР 6,3; 95% ДИ 1,1-38,1) на фоне назначения ривароксабана (n=44) по сравнению с дабигатраном (n=73) и апиксабаном (n=102) при отсутствии различий по частоте кровотечений [64]. При изучении свойств отдельных антикоагулянтов в той же популяции (n=22739 пациентов с ХБП С3-С5 стадий) большего размера наблюдалось уменьшение риска инсультов и системных эмболий при назначении апиксабана (29,6%) в сравнении с варфарином (ОР 0,70; 95% ДИ 0,51-0,96); для дабигатрана (6,9%; ОР 1,15; 95% ДИ 0,69-1,94) и ривароксабана (17,2%; ОР 0,80; 95% ДИ 0,54-1,17) подобной закономерности не наблюдалось.…”

Section: исследования реальной клинической практикиunclassified

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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Real-world 2-year outcome of atrial fibrillation treatment with dabigatran, apixaban, and rivaroxaban in patients with and without chronic kidney disease

Cited by 24 publications

References 40 publications

Treatment persistence to tolvaptan in patients with autosomal dominant polycystic kidney disease: a secondary use of data analysis of patients in the IMADJIN® dataset

Treatment persistence to tolvaptan in patients with autosomal dominant polycystic kidney disease: a secondary use of data analysis of patients in the IMADJIN® dataset

Specifics of anticoagulation in combination with atrial fibrillation and chronic kidney disease

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

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