Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2026
Hemostatic safety profile of estetrol vs. ethinylestradiol in oral contraceptives: a systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Lemos Maria Julia, Ferraz Jacqueline Maia, Queiroz Laura Fonseca, Diniz Alice França, da Silva Celene Maria Longo, Dos Santos Priscila Luiza, Gomide Patricia Myriam Antunes de Oliveira, Novellino Andrea Mora De Marco
Аннотация
OBJECTIVE: To evaluate the hemostatic profile of estetrol/drospirenone (E4/DRSP) compared with ethinylestradiol/drospirenone (EE/DRSP) in adult women.
METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was performed according to PRISMA guidelines. Eligible studies compared E4/DRSP with EE/DRSP in adult women and assessed coagulation, anticoagulation, or fibrinolytic markers. Three RCTs (n=183) met inclusion criteria. Data were extracted independently, and pooled mean differences (MD) were calculated using random-effects models.
RESULTS: Compared to EE/DRSP, E4/DRSP was associated with higher protein S activity (MD = 21.23; 95% CI: 11.83 to 30.64; p<0.00001) and lower levels of fibrinogen (MD = -24.17; 95% CI: -39.15 to -9.19; p=0.002), plasminogen (MD = -27.28; 95% CI: -27.28 to - 22.89; p<0.00001), and SHBG (MD = -183.38; 95% CI: -183.38; 95% CI: -210.93 to -155.84; p<0.00001). No significant differences were observed for D-dimer and antithrombin. Protein C activity was higher in the EE group, though this was an isolated finding with limited interpretability.
CONCLUSION: E4/DRSP demonstrates a more favorable hemostatic profile than EE/DRSP, potentially reducing thrombotic risk. Despite the limited number of RCTs, consistency across markers supports E4 as a safer estrogenic component for contraceptive formulations, with implications for women at increased risk of venous thromboembolism.PROSPERO registry: #CRD420251074961.
METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) was performed according to PRISMA guidelines. Eligible studies compared E4/DRSP with EE/DRSP in adult women and assessed coagulation, anticoagulation, or fibrinolytic markers. Three RCTs (n=183) met inclusion criteria. Data were extracted independently, and pooled mean differences (MD) were calculated using random-effects models.
RESULTS: Compared to EE/DRSP, E4/DRSP was associated with higher protein S activity (MD = 21.23; 95% CI: 11.83 to 30.64; p<0.00001) and lower levels of fibrinogen (MD = -24.17; 95% CI: -39.15 to -9.19; p=0.002), plasminogen (MD = -27.28; 95% CI: -27.28 to - 22.89; p<0.00001), and SHBG (MD = -183.38; 95% CI: -183.38; 95% CI: -210.93 to -155.84; p<0.00001). No significant differences were observed for D-dimer and antithrombin. Protein C activity was higher in the EE group, though this was an isolated finding with limited interpretability.
CONCLUSION: E4/DRSP demonstrates a more favorable hemostatic profile than EE/DRSP, potentially reducing thrombotic risk. Despite the limited number of RCTs, consistency across markers supports E4 as a safer estrogenic component for contraceptive formulations, with implications for women at increased risk of venous thromboembolism.PROSPERO registry: #CRD420251074961.