Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial
Cancer and/or major surgery are two factors that predispose to post-operative thrombosis. The annual incidence of venous thromboembolic disease (VTED) in cancer patients was estimated at 0.5%-20%. Surgery increases the risk of VTED by 29% in the absence of thromboprophylaxis. Enoxaparin is a low mol...
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| description | Cancer and/or major surgery are two factors that predispose to post-operative thrombosis. The annual incidence of venous thromboembolic disease (VTED) in cancer patients was estimated at 0.5%-20%. Surgery increases the risk of VTED by 29% in the absence of thromboprophylaxis. Enoxaparin is a low molecular weight heparin that is safe and effective. Branded Enoxaparin and biosimilar Enoxaparin are two enoxaparin treatments. This study aimed to compare Branded Enoxaparin with biosimilar Enoxaparin in patients operated on for digestive cancer regarding the prevention of postoperative thrombosis event, to compare the tolerance of the two treatments and to identify independent predictive factors of thromboembolic incident. A randomized controlled trial conducted in a single-centre, surgical department B of Charles Nicolle Hospital, over a 5-year period from October 12.sup.th, 2015, to July 08.sup.th, 2020. We included all patients over 18 who had cancer of the digestive tract newly diagnosed, operable and whatever its nature, site, or stage, operated on in emergency or elective surgery. The primary endpoint was any asymptomatic thromboembolic event, demonstrated by systematic US Doppler of the lower limbs on postoperative day 7 to day 10. The sonographer was unaware of the prescribed treatment (Branded Enoxaparin [BE] or biosimilar Enoxaparin [BSE]). Of one hundred sixty-eight enrolled patients, six patients (4.1%) had subclinical venous thrombosis. Among those who had subclinical thrombosis, four patients (5.6%) were in the Branded Enoxaparin group and two patients (2.7%) in the Biosimilar Enoxaparin group without statistically significant difference (p = 0.435). Analysis of the difference in means using Student's t test demonstrated the equivalence of the two treatments. Our study allowed us to conclude that there was no statistically significant difference between Branded Enoxaparin and Biosimilar Enoxaparin regarding the occurrence of thromboembolic accidents postoperatively. BE and BSE are equivalent. |
| doi_str_mv | 10.1371/journal.pone.0293269 |
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The annual incidence of venous thromboembolic disease (VTED) in cancer patients was estimated at 0.5%-20%. Surgery increases the risk of VTED by 29% in the absence of thromboprophylaxis. Enoxaparin is a low molecular weight heparin that is safe and effective. Branded Enoxaparin and biosimilar Enoxaparin are two enoxaparin treatments. This study aimed to compare Branded Enoxaparin with biosimilar Enoxaparin in patients operated on for digestive cancer regarding the prevention of postoperative thrombosis event, to compare the tolerance of the two treatments and to identify independent predictive factors of thromboembolic incident. A randomized controlled trial conducted in a single-centre, surgical department B of Charles Nicolle Hospital, over a 5-year period from October 12.sup.th, 2015, to July 08.sup.th, 2020. We included all patients over 18 who had cancer of the digestive tract newly diagnosed, operable and whatever its nature, site, or stage, operated on in emergency or elective surgery. The primary endpoint was any asymptomatic thromboembolic event, demonstrated by systematic US Doppler of the lower limbs on postoperative day 7 to day 10. The sonographer was unaware of the prescribed treatment (Branded Enoxaparin [BE] or biosimilar Enoxaparin [BSE]). Of one hundred sixty-eight enrolled patients, six patients (4.1%) had subclinical venous thrombosis. Among those who had subclinical thrombosis, four patients (5.6%) were in the Branded Enoxaparin group and two patients (2.7%) in the Biosimilar Enoxaparin group without statistically significant difference (p = 0.435). Analysis of the difference in means using Student's t test demonstrated the equivalence of the two treatments. Our study allowed us to conclude that there was no statistically significant difference between Branded Enoxaparin and Biosimilar Enoxaparin regarding the occurrence of thromboembolic accidents postoperatively. BE and BSE are equivalent.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0293269</identifier><identifier>PMID: 37910523</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Analysis ; Anticoagulants ; Biological products ; Cancer ; Cancer surgery ; Cancer therapies ; Care and treatment ; Chemotherapy ; Clinical trials ; Complications ; Diagnosis ; Equivalence ; Gastrointestinal tract ; Heparin ; Kidney diseases ; Low molecular weights ; Medicine and Health Sciences ; Molecular weight ; Mortality ; Oncology, Experimental ; Patients ; Radiation therapy ; Research and Analysis Methods ; Risk factors ; Software ; Statistical analysis ; Surgery ; Thrombocytopenia ; Thromboembolism ; Thrombosis ; Ultrasonic imaging ; Variables ; Venous thrombosis</subject><ispartof>PloS one, 2023-11, Vol.18 (11), p.e0293269-e0293269</ispartof><rights>COPYRIGHT 2023 Public Library of Science</rights><rights>2023 Dziri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 Dziri et al 2023 Dziri et al</rights><rights>2023 Dziri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c619t-d410c6e7368bce62d016834014f08af89d820eb2f88f9b6c6777705e345fc25f3</cites><orcidid>0000-0003-2779-0930</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10619849/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10619849/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79343,79344</link.rule.ids></links><search><contributor>Cruz, Ricardo Pedrini</contributor><creatorcontrib>Dziri, Chadli</creatorcontrib><creatorcontrib>Ben Hmida, Wafa</creatorcontrib><creatorcontrib>Dougaz, Wejih</creatorcontrib><creatorcontrib>Khalfallah, Mehdi</creatorcontrib><creatorcontrib>Samaali, Imen</creatorcontrib><creatorcontrib>Jerraya, Hichem</creatorcontrib><creatorcontrib>Bouasker, Ibtissem</creatorcontrib><creatorcontrib>Nouira, Ramzi</creatorcontrib><title>Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial</title><title>PloS one</title><description>Cancer and/or major surgery are two factors that predispose to post-operative thrombosis. 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The annual incidence of venous thromboembolic disease (VTED) in cancer patients was estimated at 0.5%-20%. Surgery increases the risk of VTED by 29% in the absence of thromboprophylaxis. Enoxaparin is a low molecular weight heparin that is safe and effective. Branded Enoxaparin and biosimilar Enoxaparin are two enoxaparin treatments. This study aimed to compare Branded Enoxaparin with biosimilar Enoxaparin in patients operated on for digestive cancer regarding the prevention of postoperative thrombosis event, to compare the tolerance of the two treatments and to identify independent predictive factors of thromboembolic incident. A randomized controlled trial conducted in a single-centre, surgical department B of Charles Nicolle Hospital, over a 5-year period from October 12.sup.th, 2015, to July 08.sup.th, 2020. We included all patients over 18 who had cancer of the digestive tract newly diagnosed, operable and whatever its nature, site, or stage, operated on in emergency or elective surgery. The primary endpoint was any asymptomatic thromboembolic event, demonstrated by systematic US Doppler of the lower limbs on postoperative day 7 to day 10. The sonographer was unaware of the prescribed treatment (Branded Enoxaparin [BE] or biosimilar Enoxaparin [BSE]). Of one hundred sixty-eight enrolled patients, six patients (4.1%) had subclinical venous thrombosis. Among those who had subclinical thrombosis, four patients (5.6%) were in the Branded Enoxaparin group and two patients (2.7%) in the Biosimilar Enoxaparin group without statistically significant difference (p = 0.435). Analysis of the difference in means using Student's t test demonstrated the equivalence of the two treatments. Our study allowed us to conclude that there was no statistically significant difference between Branded Enoxaparin and Biosimilar Enoxaparin regarding the occurrence of thromboembolic accidents postoperatively. BE and BSE are equivalent.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>37910523</pmid><doi>10.1371/journal.pone.0293269</doi><tpages>e0293269</tpages><orcidid>https://orcid.org/0000-0003-2779-0930</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | PloS one, 2023-11, Vol.18 (11), p.e0293269-e0293269 |
| issn | 1932-6203 1932-6203 |
| language | eng |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Analysis Anticoagulants Biological products Cancer Cancer surgery Cancer therapies Care and treatment Chemotherapy Clinical trials Complications Diagnosis Equivalence Gastrointestinal tract Heparin Kidney diseases Low molecular weights Medicine and Health Sciences Molecular weight Mortality Oncology, Experimental Patients Radiation therapy Research and Analysis Methods Risk factors Software Statistical analysis Surgery Thrombocytopenia Thromboembolism Thrombosis Ultrasonic imaging Variables Venous thrombosis |
| title | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-30T22%3A25%3A31IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Biosimilar%20versus%20branded%20enoxaparin%20to%20prevent%20postoperative%20venous%20thromboembolism%20after%20surgery%20for%20digestive%20tract%20cancer:%20Randomized%20trial&rft.jtitle=PloS%20one&rft.au=Dziri,%20Chadli&rft.date=2023-11-01&rft.volume=18&rft.issue=11&rft.spage=e0293269&rft.epage=e0293269&rft.pages=e0293269-e0293269&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0293269&rft_dat=%3Cgale_plos_%3EA771106652%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3069192114&rft_id=info:pmid/37910523&rft_galeid=A771106652&rft_doaj_id=oai_doaj_org_article_1a00414cf77049bdafd31a0cddbd0ea0&rfr_iscdi=true |