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...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0293269&type=printable |
| _version_ | 1797635184462397440 |
|---|---|
| author | Chadli Dziri Wafa Ben Hmida Wejih Dougaz Mehdi Khalfallah Imen Samaali Hichem Jerraya Ibtissem Bouasker Ramzi Nouira |
| author_facet | Chadli Dziri Wafa Ben Hmida Wejih Dougaz Mehdi Khalfallah Imen Samaali Hichem Jerraya Ibtissem Bouasker Ramzi Nouira |
| author_sort | Chadli Dziri |
| collection | DOAJ |
| 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 12th, 2015, to July 08th, 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. Trial registration. Trial registration: The trial was registered on CLINICALTRIALS.GOV under the number NCT02444572. |
| first_indexed | 2024-03-11T12:18:35Z |
| format | Article |
| id | doaj.art-42f72f4fb46e4779aa0e53027b384fbc |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-11T12:18:35Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-42f72f4fb46e4779aa0e53027b384fbc2023-11-07T05:34:55ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-011811e029326910.1371/journal.pone.0293269Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial.Chadli DziriWafa Ben HmidaWejih DougazMehdi KhalfallahImen SamaaliHichem JerrayaIbtissem BouaskerRamzi NouiraCancer 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 12th, 2015, to July 08th, 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. Trial registration. Trial registration: The trial was registered on CLINICALTRIALS.GOV under the number NCT02444572.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0293269&type=printable |
| spellingShingle | Chadli Dziri Wafa Ben Hmida Wejih Dougaz Mehdi Khalfallah Imen Samaali Hichem Jerraya Ibtissem Bouasker Ramzi Nouira Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS ONE |
| title | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. |
| title_full | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. |
| title_fullStr | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. |
| title_full_unstemmed | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. |
| title_short | Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. |
| title_sort | biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer randomized trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0293269&type=printable |
| work_keys_str_mv | AT chadlidziri biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT wafabenhmida biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT wejihdougaz biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT mehdikhalfallah biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT imensamaali biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT hichemjerraya biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT ibtissembouasker biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial AT ramzinouira biosimilarversusbrandedenoxaparintopreventpostoperativevenousthromboembolismaftersurgeryfordigestivetractcancerrandomizedtrial |