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Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study
BACKGROUND: Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844336/ https://www.ncbi.nlm.nih.gov/pubmed/34435340 http://dx.doi.org/10.1007/s40801-021-00273-4 |
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author | Ramakrishna, Pinjala Gupta, P. C. Pai, Paresh Rai, Kumud Rajkumar, M. Sahu, Tapish Khan, Mohammed Yunus Gaurav, Kumar Mane, Amey Pandit, Sucheta Jain, Madhur Subramaniyan, Anand |
author_facet | Ramakrishna, Pinjala Gupta, P. C. Pai, Paresh Rai, Kumud Rajkumar, M. Sahu, Tapish Khan, Mohammed Yunus Gaurav, Kumar Mane, Amey Pandit, Sucheta Jain, Madhur Subramaniyan, Anand |
author_sort | Ramakrishna, Pinjala |
collection | PubMed |
description | BACKGROUND: Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. OBJECTIVE: To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. METHODS: Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. RESULTS: The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). CONCLUSIONS: The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00273-4. |
format | Online Article Text |
id | pubmed-8844336 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-88443362022-02-23 Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study Ramakrishna, Pinjala Gupta, P. C. Pai, Paresh Rai, Kumud Rajkumar, M. Sahu, Tapish Khan, Mohammed Yunus Gaurav, Kumar Mane, Amey Pandit, Sucheta Jain, Madhur Subramaniyan, Anand Drugs Real World Outcomes Original Research Article BACKGROUND: Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. OBJECTIVE: To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. METHODS: Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. RESULTS: The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). CONCLUSIONS: The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-021-00273-4. Springer International Publishing 2021-08-25 /pmc/articles/PMC8844336/ /pubmed/34435340 http://dx.doi.org/10.1007/s40801-021-00273-4 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Article Ramakrishna, Pinjala Gupta, P. C. Pai, Paresh Rai, Kumud Rajkumar, M. Sahu, Tapish Khan, Mohammed Yunus Gaurav, Kumar Mane, Amey Pandit, Sucheta Jain, Madhur Subramaniyan, Anand Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title | Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title_full | Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title_fullStr | Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title_full_unstemmed | Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title_short | Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study |
title_sort | effectiveness and tolerability of fondaparinux vs enoxaparin in a population of indian patients with symptomatic deep vein thrombosis: a retrospective real-world study |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844336/ https://www.ncbi.nlm.nih.gov/pubmed/34435340 http://dx.doi.org/10.1007/s40801-021-00273-4 |
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