Estetrol/Drospirenone Safety in a Population with Cardiovascular Risk Factors.

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, 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.