Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia
Электронный научный архив УРФУ
Информация об архиве | Просмотр оригинала| Поле | Значение | |
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Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia
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| Автор |
Brandão, L. R.
Tartakovsky, I. Albisetti, M. Halton, J. Bomgaars, L. Chalmers, E. Luciani, M. Saracco, P. Felgenhauer, J. Lvova, O. Simetzberger, M. Sun, Z. Mitchell, L. G. |
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| Тематика |
BLOOD CLOTTING FACTOR 5 LEIDEN
DABIGATRAN PHOSPHOLIPID ANTIBODY PROTHROMBIN PROTHROMBIN ANTIBODY ADVERSE OUTCOME ALOPECIA ARTICLE CHILD CLINICAL EFFECTIVENESS CLINICAL FEATURE DISEASE EXACERBATION DRUG EFFECT DRUG EFFICACY DRUG RESPONSE DRUG SAFETY EPISTAXIS FEMALE HEADACHE HUMAN MAJOR CLINICAL STUDY MALE PHASE 3 CLINICAL TRIAL RECURRENT DISEASE RHINOPHARYNGITIS RISK FACTOR THROMBOPHILIA THROMBOSIS PREVENTION TREATMENT OUTCOME VENOUS THROMBOEMBOLISM |
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| Описание |
In the phase 2b/3 DIVERSITY trial, 3 months treatment with dabigatran was noninferior to standard of care (SOC) for acute venous thromboembolism (VTE) in children. In a single-arm, phase 3, secondary VTE prevention study, up to 12 months dabigatran use was associated with favorable safety. Dabigatran is approved by the European Medicines Agency and US Food and Drug Administration for pediatric indications. We assessed primary composite efficacy (complete thrombus resolution and freedom from VTE recurrence/VTE-related death) in subgroups with thrombophilia vs those with negative/unknown thrombophilia status in the DIVERSITY trial and safety in both studies. Thrombophilia types were similar between the DIVERSITY trial (total population) and secondary prevention studies: factor V Leiden, 42% vs 33%; prothrombin mutation (G20210A), 19% vs 17%; antithrombin deficiency, 15% vs 20%; protein C/S deficiency, 23% vs 25%; and antiphospholipid antibodies, 18% vs 20% of patients, respectively. In DIVERSITY, 36% and 22% of thrombophilia subgroup patients treated with dabigatran and SOC, respectively, met the primary end point (Mantel-Haenszel–weighted rate difference, -0.135; 95% confidence interval, -0.36 to 0.08; noninferiority P = .0014); comparable to the total DIVERSITY trial population (46% vs 42%) showing dabigatran noninferiority to SOC. Within this subgroup, numerically fewer patients experienced VTE recurrence or progression of index thrombus in the dabigatran treatment group vs SOC. In the secondary prevention study, VTE recurrence at 12 months occurred in 2.8% of patients with thrombophilia vs 0% with negative/unknown thrombophilia. Safety profiles were consistent with those reported previously. Although they should be interpreted with caution, these exploratory findings suggest dabigatran could be an appropriate long-term anticoagulant for children with thrombophilia. © 2022 by The American Society of Hematology.
Boehringer Ingelheim The study was supported financially by Boehringer Ingelheim International GmbH. |
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| Дата |
2024-04-08T11:07:20Z
2024-04-08T11:07:20Z 2022 |
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| Тип |
Article
Journal article (info:eu-repo/semantics/article) Published version (info:eu-repo/semantics/publishedVersion) |
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| Идентификатор |
Brandão, LR, Tartakovsky, I, Albisetti, M, Halton, J, Bomgaars, L, Chalmers, E, Luciani, M, Saracco, P, Felgenhauer, J, Lvova, O, Simetzberger, M, Sun, Z & Mitchell, LG 2022, 'Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia', Blood Advances, Том. 6, № 22, стр. 5908-5923. https://doi.org/10.1182/bloodadvances.2021005681
Brandão, L. R., Tartakovsky, I., Albisetti, M., Halton, J., Bomgaars, L., Chalmers, E., Luciani, M., Saracco, P., Felgenhauer, J., Lvova, O., Simetzberger, M., Sun, Z., & Mitchell, L. G. (2022). Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Advances, 6(22), 5908-5923. https://doi.org/10.1182/bloodadvances.2021005681 2473-9529 Final All Open Access; Gold Open Access; Green Open Access https://ashpublications.org/bloodadvances/article-pdf/6/22/5908/1929545/blooda_adv-2021-005681-main.pdf https://ashpublications.org/bloodadvances/article-pdf/6/22/5908/1929545/blooda_adv-2021-005681-main.pdf http://elar.urfu.ru/handle/10995/131435 10.1182/bloodadvances.2021005681 85143118299 000913702900015 |
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| Язык |
en
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| Права |
Open access (info:eu-repo/semantics/openAccess)
cc-by-nc-nd https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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application/pdf
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American Society of Hematology
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| Источник |
Blood Advances
Blood Advances |
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