| アブストラクト | BACKGROUND: Disproportionality analyses using pharmacovigilance databases permit comparisons between products for rare outcomes, such as venous thromboembolism with combined oral contraceptives. OBJECTIVE: To compare the proportionality reporting rate of venous thromboembolic adverse events in the Food and Drug Administration Adverse Reporting System database between 2 body-identical estrogen combined oral contraceptives available in the United States, 17beta-estradiol valerate/dienogest and estetrol/drospirenone, and combined oral contraceptives containing ethinyl estradiol. STUDY DESIGN: We extracted individual case safety reports and adverse events from the Food and Drug Administration Adverse Reporting System database from its inception to October 2024. We performed a proportionality reporting rate analysis of venous thromboembolic events associated with various combined oral contraceptives as compared to reference standards of ethinyl estradiol/levonorgestrel combined oral contraceptives and the entire therapeutic class. Secondarily, we assessed the proportionality reporting rate with drospirenone-only pills and norethindrone-only pills. RESULTS: Compared to ethinyl estradiol/levonorgestrel, we found lower proportionality reporting rates with estetrol/drospirenone (0.54; 95% confidence interval, 0.30-0.99) and 17beta-estradiol valerate/dienogest (0.79 [5]; 95% confidence interval, 0.65-0.97), which were similar to the proportionality reporting rates for drospirenone-only pills (0.64; 95% confidence interval, 0.55-0.74) and norethindrone-only pills (0.69; 95% confidence interval, 0.60-0.79). Ethinyl estradiol/drospirenone had the highest proportionality reporting rate at 5.18 (95% confidence interval, 4.95-5.42). Using the entire therapeutic class as reference, we similarly found lower proportionality reporting rates with estetrol/drospirenone (0.17; 95% confidence interval, 0.09-0.31) and 17beta-estradiol valerate/dienogest (0.25; 95% confidence interval, 0.21-0.30), both of which were similar to the proportionality reporting rate observed for drospirenone-only pills (0.20; 95% confidence interval, 0.17-0.23) and norethindrone-only pills (0.21; 95% confidence interval, 0.19-0.24); the highest proportionality reporting rate, for ethinyl estradiol/drospirenone, was 4.52 (95% confidence interval, 4.41-4.63). CONCLUSION: Combined oral contraceptives containing body-identical estrogens, estetrol, and 17beta-estradiol have lower proportions of venous thromboembolism reports than ethinyl estradiol-based pills and are similar to progestin-only pills. These findings suggest a potentially safer thrombotic profile of body-identical estrogen-based combined oral contraceptives. |
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| ジャーナル名 | American journal of obstetrics and gynecology |
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| Pubmed追加日 | 2026/3/7 |
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| 投稿者 | Raskin, Lucie; Didembourg, Marie; Dogne, Jean-Michel; Locquet, Medea; Creinin, Mitchell D; Beaudart, Charlotte; Douxfils, Jonathan |
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| 組織名 | Clinical Pharmacology and Toxicology Research Unit, Namur Research Institute for;Life Sciences (NARILIS), Faculty of Medicine, University of Namur, Namur,;Belgium.;National Institute for Medical Research (Inserm), Unit 1018 Centre for Research;in Epidemiology and Population Health, laboratory of "Epidemiology of radiations,;clinical epidemiology, and cancer survivorship", Paris-Saclay University, Gustave;Roussy Institute, Gif-Sur-Yvette, France; Public Health Aging Research &;Epidemiology (PHARE) Group, Clinical Pharmacology and Toxicology Research Unit,;Namur Research Institute for Life Sciences, Faculty of Medicine, University of;Namur, Namur, Belgium.;Department of Obstetrics and Gynecology, University of California, Davis,;Sacramento, CA.;Belgium; Public Health Aging Research & Epidemiology (PHARE) Group, Clinical;Pharmacology and Toxicology Research Unit, Namur Research Institute for Life;Sciences, Faculty of Medicine, University of Namur, Namur, Belgium.;Belgium; Department of Biological Hematology, Centre Hospitalier Universitaire;Clermont-Ferrand, Hopital Estaing, Clermont-Ferrand, France. Electronic address:;jonathan.douxfils@unamur.be. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41791560/ |
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