Liver Safety Comparison of Bemiparin and Enoxaparin in Pregnancy: Insights From a Real-World Study
Author(s)
Yaohua Cao, PhD1, Chenli Ye, MS2, Carolina Oi Lam Ung, PhD1, Jiang Liu, BSc2, Weiling Cao, BSc2.
1The State Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical, University of Macau, Macao, China, 2Department of Pharmacy, Shenzhen Luohu District People's Hospital, Shenzhen, China.
1The State Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical, University of Macau, Macao, China, 2Department of Pharmacy, Shenzhen Luohu District People's Hospital, Shenzhen, China.
OBJECTIVES: Venous thromboembolism has become one of the leading causes of maternal mortality worldwide especially in some developed countries. Low-molecular-weight heparins play a critical role in thromboprophylaxis. This study aims to evaluate the safety and effectiveness of enoxaparin and bemiparin based on real-world data.
METHODS: In this study, we extracted medical record data of patients from the Hospital Information System of Shenzhen Luohu District People’s Hospital, and performed analysis using propensity score matching. Patients were stratified into two groups according to the drug received. Covariates for matching included control variables specified in the study model: age, ethnicity, history of allergy, embryo transfer status, treatment duration, and concomitant medication use. A 1:1 nearest-neighbor matching with a caliper width of 0.2 was employed to balance baseline characteristics between groups.
RESULTS: A total of 104 patients were included in the study. According to the average treatment effect analysis, the incidence of liver injury in the bemiparin group was significantly lower than that in the enoxaparin group (1/52 vs 10/52, odds ratio = 0.082, 95% confidence interval = 0.01 - 0.67, p = 0.008). There was no significant difference between the bemiparin group and the enoxaparin group in the incidence of bleeding (8/52 vs 3/52, odds ratio = 2.97, 95% confidence interval = 0.74 - 11.90, p = 0.201) or the occurrence of miscarriage (18/52 vs 15/52, odds ratio 1.32, 95% confidence interval = 0.57 - 3.08, p = 0.518). The incidence of venous thromboembolism and renal injury was too low for statistical evaluation.
CONCLUSIONS: This study suggested that enoxaparin was associated with a significantly higher incidence of liver injury events compared to bemiparin. Therefore, continuous monitoring of liver function is warranted when pregnant patients are treated especially with enoxaparin, and educating patients about the signs of liver injury such as abdominal pain or nausea is also crucial.
METHODS: In this study, we extracted medical record data of patients from the Hospital Information System of Shenzhen Luohu District People’s Hospital, and performed analysis using propensity score matching. Patients were stratified into two groups according to the drug received. Covariates for matching included control variables specified in the study model: age, ethnicity, history of allergy, embryo transfer status, treatment duration, and concomitant medication use. A 1:1 nearest-neighbor matching with a caliper width of 0.2 was employed to balance baseline characteristics between groups.
RESULTS: A total of 104 patients were included in the study. According to the average treatment effect analysis, the incidence of liver injury in the bemiparin group was significantly lower than that in the enoxaparin group (1/52 vs 10/52, odds ratio = 0.082, 95% confidence interval = 0.01 - 0.67, p = 0.008). There was no significant difference between the bemiparin group and the enoxaparin group in the incidence of bleeding (8/52 vs 3/52, odds ratio = 2.97, 95% confidence interval = 0.74 - 11.90, p = 0.201) or the occurrence of miscarriage (18/52 vs 15/52, odds ratio 1.32, 95% confidence interval = 0.57 - 3.08, p = 0.518). The incidence of venous thromboembolism and renal injury was too low for statistical evaluation.
CONCLUSIONS: This study suggested that enoxaparin was associated with a significantly higher incidence of liver injury events compared to bemiparin. Therefore, continuous monitoring of liver function is warranted when pregnant patients are treated especially with enoxaparin, and educating patients about the signs of liver injury such as abdominal pain or nausea is also crucial.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO160
Topic
Clinical Outcomes, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Alternative Medicine, Reproductive & Sexual Health, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)