Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors

Mitchell D Creinin; Jean Michel Foidart; Kristina Gemzell-Danielsson; Nina C Flerin; Ali Kubba; Ulysse Gaspard; Jonathan Douxfils

doi:10.1016/j.contraception.2025.110861

Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors

Mitchell D Creinin, Jean Michel Foidart, Kristina Gemzell-Danielsson, Nina C Flerin, Ali Kubba, Ulysse Gaspard, Jonathan Douxfils

Résultats de recherche: Contribution à un journal/une revue › Article › Revue par des pairs

Résumé

OBJECTIVES: To evaluate cardiovascular safety outcomes in estetrol 15mg/drospirenone 3mg users with cardiovascular risk factors.

STUDY DESIGN: We performed a secondary analysis of two open-label contraceptive phase-3 trials that enrolled participants 16 to 50 years to use estetrol/drospirenone for up to 13 cycles. Study exclusion criteria included >35 years and smoking, body mass index (BMI) >35 kg/m 2, and baseline blood pressure (BP) >140/90 mmHg. We compared adverse event rates in participants with and without cardiovascular risk factors and assessed discontinuation rates for cardiovascular adverse events.

RESULTS: Of 3417 participants, 1410 (41.3%) had one or more and 309 (9.0%) had two or more cardiovascular risk factors. We found no difference in discontinuation for any adverse events in participants with and without cardiovascular risk factors. Six (0.18%) participants discontinued for a cardiovascular complaint including four with risk factors: three (0.09%) due to hypertension (all had baseline BP ≥130/85 mmHg and one or more additional risk factors) and one due to venous thrombosis (BP ≥130/85 mmHg). Of 375 participants with baseline BP ≥130/85 mmHg, 0.8% (95% CI 0-1.7%) discontinued for hypertension while among the 192 participants with baseline BP ≥130/85 mmHg and one or more additional cardiovascular risk factors, 1.6% (95% CI 0-3.3%) discontinued for hypertension.

CONCLUSION: Among >1400 study participants with cardiovascular risk factors using estetrol/drospirenone, only three (0.2%) discontinued for hypertension, all of whom had high-normal baseline BP and at least one other risk cardiovascular risk factor.

langue originale	Anglais
Pages (de - à)	110861
journal	Contraception
Les DOIs	https://doi.org/10.1016/j.contraception.2025.110861
Etat de la publication	E-pub ahead of print - 28 févr. 2025

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10.1016/j.contraception.2025.110861

Clinical Pharmacology Research Group
Douxfils, J. (Promoteur), Dogné, J.-M. (Promoteur), Musuamba Tshinanu, F. (Promoteur), Masereel, B. (Promoteur), Wieërs, G. (Promoteur), Haguet, H. (Chercheur), RONVAUX, L. (Chercheur), Donis, N. (Chercheur), Morimont, L. (Chercheur), Evrard, J. (Chercheur), Siriez, R. (Chercheur), Gillot, C. (Chercheur), FAVRESSE, J. (Chercheur), BOUVY, C. (Chercheur), Djokoto, H. (Chercheur), Didembourg, M. (Chercheur), David, C. (Rôle de support), Melchionda, S. (Rôle de support), Maloteau, V. (Technicien), Boucher, A.-Y. (Technicien), Devel, P. (Technicien), Modaffari, E. (Technicien), Vandeputte, M. (Technicien), De Messemaeker, A. (Secrétaire), Decarpentrie, J. (Chercheur), Vassart, J. (Chercheur) & De Groote, A. (Chercheur)
1/04/22 → …
Projet: Axe de recherche

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title = "Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors",

abstract = "OBJECTIVES: To evaluate cardiovascular safety outcomes in estetrol 15mg/drospirenone 3mg users with cardiovascular risk factors.STUDY DESIGN: We performed a secondary analysis of two open-label contraceptive phase-3 trials that enrolled participants 16 to 50 years to use estetrol/drospirenone for up to 13 cycles. Study exclusion criteria included >35 years and smoking, body mass index (BMI) >35 kg/m 2, and baseline blood pressure (BP) >140/90 mmHg. We compared adverse event rates in participants with and without cardiovascular risk factors and assessed discontinuation rates for cardiovascular adverse events. RESULTS: Of 3417 participants, 1410 (41.3%) had one or more and 309 (9.0%) had two or more cardiovascular risk factors. We found no difference in discontinuation for any adverse events in participants with and without cardiovascular risk factors. Six (0.18%) participants discontinued for a cardiovascular complaint including four with risk factors: three (0.09%) due to hypertension (all had baseline BP ≥130/85 mmHg and one or more additional risk factors) and one due to venous thrombosis (BP ≥130/85 mmHg). Of 375 participants with baseline BP ≥130/85 mmHg, 0.8% (95% CI 0-1.7%) discontinued for hypertension while among the 192 participants with baseline BP ≥130/85 mmHg and one or more additional cardiovascular risk factors, 1.6% (95% CI 0-3.3%) discontinued for hypertension.CONCLUSION: Among >1400 study participants with cardiovascular risk factors using estetrol/drospirenone, only three (0.2%) discontinued for hypertension, all of whom had high-normal baseline BP and at least one other risk cardiovascular risk factor.",

author = "Creinin, {Mitchell D} and Foidart, {Jean Michel} and Kristina Gemzell-Danielsson and Flerin, {Nina C} and Ali Kubba and Ulysse Gaspard and Jonathan Douxfils",

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T1 - Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors

AU - Creinin, Mitchell D

AU - Foidart, Jean Michel

AU - Gemzell-Danielsson, Kristina

AU - Flerin, Nina C

AU - Kubba, Ali

AU - Gaspard, Ulysse

AU - Douxfils, Jonathan

PY - 2025/2/28

Y1 - 2025/2/28

N2 - OBJECTIVES: To evaluate cardiovascular safety outcomes in estetrol 15mg/drospirenone 3mg users with cardiovascular risk factors.STUDY DESIGN: We performed a secondary analysis of two open-label contraceptive phase-3 trials that enrolled participants 16 to 50 years to use estetrol/drospirenone for up to 13 cycles. Study exclusion criteria included >35 years and smoking, body mass index (BMI) >35 kg/m 2, and baseline blood pressure (BP) >140/90 mmHg. We compared adverse event rates in participants with and without cardiovascular risk factors and assessed discontinuation rates for cardiovascular adverse events. RESULTS: Of 3417 participants, 1410 (41.3%) had one or more and 309 (9.0%) had two or more cardiovascular risk factors. We found no difference in discontinuation for any adverse events in participants with and without cardiovascular risk factors. Six (0.18%) participants discontinued for a cardiovascular complaint including four with risk factors: three (0.09%) due to hypertension (all had baseline BP ≥130/85 mmHg and one or more additional risk factors) and one due to venous thrombosis (BP ≥130/85 mmHg). Of 375 participants with baseline BP ≥130/85 mmHg, 0.8% (95% CI 0-1.7%) discontinued for hypertension while among the 192 participants with baseline BP ≥130/85 mmHg and one or more additional cardiovascular risk factors, 1.6% (95% CI 0-3.3%) discontinued for hypertension.CONCLUSION: Among >1400 study participants with cardiovascular risk factors using estetrol/drospirenone, only three (0.2%) discontinued for hypertension, all of whom had high-normal baseline BP and at least one other risk cardiovascular risk factor.

AB - OBJECTIVES: To evaluate cardiovascular safety outcomes in estetrol 15mg/drospirenone 3mg users with cardiovascular risk factors.STUDY DESIGN: We performed a secondary analysis of two open-label contraceptive phase-3 trials that enrolled participants 16 to 50 years to use estetrol/drospirenone for up to 13 cycles. Study exclusion criteria included >35 years and smoking, body mass index (BMI) >35 kg/m 2, and baseline blood pressure (BP) >140/90 mmHg. We compared adverse event rates in participants with and without cardiovascular risk factors and assessed discontinuation rates for cardiovascular adverse events. RESULTS: Of 3417 participants, 1410 (41.3%) had one or more and 309 (9.0%) had two or more cardiovascular risk factors. We found no difference in discontinuation for any adverse events in participants with and without cardiovascular risk factors. Six (0.18%) participants discontinued for a cardiovascular complaint including four with risk factors: three (0.09%) due to hypertension (all had baseline BP ≥130/85 mmHg and one or more additional risk factors) and one due to venous thrombosis (BP ≥130/85 mmHg). Of 375 participants with baseline BP ≥130/85 mmHg, 0.8% (95% CI 0-1.7%) discontinued for hypertension while among the 192 participants with baseline BP ≥130/85 mmHg and one or more additional cardiovascular risk factors, 1.6% (95% CI 0-3.3%) discontinued for hypertension.CONCLUSION: Among >1400 study participants with cardiovascular risk factors using estetrol/drospirenone, only three (0.2%) discontinued for hypertension, all of whom had high-normal baseline BP and at least one other risk cardiovascular risk factor.

U2 - 10.1016/j.contraception.2025.110861

DO - 10.1016/j.contraception.2025.110861

M3 - Article

C2 - 40024362

SN - 0010-7824

SP - 110861

JO - Contraception

JF - Contraception

ER -

Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors

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