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Structured benefit--risk assessment for enoxaparin, based on real-world evidence in the context of its label extension, for the extended treatment of deep vein thrombosis and pulmonary embolism, and prevention of its recurrence in patients with active cancer
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  • Marie-Laure Kürzinger,
  • Chantal El-Haddad,
  • Tatiana Gouin-Soboleva,
  • Zita Fazekas,
  • Denis Granados,
  • Elizabeth Benito-Garcia,
  • Yasmina Djoudi
Marie-Laure Kürzinger
Sanofi-Aventis Recherche Developpement Chilly-Mazarin Longjumeau

Corresponding Author:[email protected]

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Chantal El-Haddad
Sanofi-Aventis Recherche Developpement Chilly-Mazarin Longjumeau
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Tatiana Gouin-Soboleva
Sanofi-Aventis France SA Massy
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Zita Fazekas
Sanofi-Aventis GmbH
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Denis Granados
Sanofi-Aventis Recherche Developpement Chilly-Mazarin Longjumeau
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Elizabeth Benito-Garcia
Sanofi Genzyme Switzerland
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Yasmina Djoudi
Sanofi-Aventis France SA Massy
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Abstract

Purpose Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit–risk profile of enoxaparin with dalteparin and tinzaparin, based on real-world evidence (RWE) for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. Methods A semi-quantitative structured benefit–risk assessment was conducted for the label-extension application of enoxaparin employing the following steps of the benefit–risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results. Results The key benefits were defined as reduced all-cause mortality and VTE recurrence (including symptomatic DVT, fatal PE and non-fatal PE); the key risks were major and non-major bleeding of clinical significance. When compared with other EEA-approved LMWHs (dalteparin, tinzaparin), enoxaparin demonstrated a trend toward favourable effects for the reduction of VTE recurrence and all-cause mortality. There was a trend in favour of other LMWHs for major bleeding, and a trend in favour of enoxaparin for non-major bleeding with no evidence of significant difference between enoxaparin and the comparator groups. Conclusions The assessment using RWE demonstrated a favourable benefit–risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.
02 Feb 2023Submitted to Pharmacoepidemiology and Drug Safety
02 Feb 2023Submission Checks Completed
02 Feb 2023Assigned to Editor
02 Feb 2023Review(s) Completed, Editorial Evaluation Pending
04 Apr 2023Reviewer(s) Assigned
31 Aug 2023Editorial Decision: Revise Major
03 Nov 20231st Revision Received
03 Nov 2023Submission Checks Completed
03 Nov 2023Assigned to Editor
03 Nov 2023Review(s) Completed, Editorial Evaluation Pending
22 Nov 2023Reviewer(s) Assigned
18 Mar 20242nd Revision Received
18 Mar 2024Review(s) Completed, Editorial Evaluation Pending
19 Mar 2024Submission Checks Completed
19 Mar 2024Assigned to Editor