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Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia

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Поле Значение
 
Заглавие Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia
 
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.
 
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
 
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.
 
Дата 2024-04-08T11:07:20Z
2024-04-08T11:07:20Z
2022
 
Тип Article
Journal article (info:eu-repo/semantics/article)
Published version (info:eu-repo/semantics/publishedVersion)
 
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
 
Язык en
 
Права Open access (info:eu-repo/semantics/openAccess)
cc-by-nc-nd
https://creativecommons.org/licenses/by-nc-nd/4.0/
 
Формат application/pdf
 
Издатель American Society of Hematology
 
Источник Blood Advances
Blood Advances