| アブストラクト | BACKGROUND: Deep vein thrombosis (DVT) has been reported as an adverse event for patients receiving combined oral contraceptives. Norethindrone/ethinyl estradiol (NET/EE) and drospirenone/ethinyl estradiol (DRSP/EE) are two commonly prescribed combined hormonal oral contraceptive agents used in the United States, differing in their progestin component. OBJECTIVE: The purpose of this study was to determine the association between the progestin component of a combined oral contraceptive and the risk of DVT in patients taking oral contraceptives for birth control using data derived from the FDA Adverse Event Reporting System (FAERS). METHODS: The risk of DVT was compared between patients that had taken NET/EE with those that had taken the DRSP/EE COC formulation for birth control. In addition, age was assessed as a possible confounder and the outcome severity for those diagnosed with DVT were compared between the two groups. Finally, association rule mining was utilized to identify possible drug-drug interactions that result in elevated DVT risk. RESULTS: DVT was the fourth most commonly adverse event reported for patients taking DRSP/EE accounting for 8558 cases and the seventeenth most commonly reported adverse event for NET/EE accounting for 298 cases. Age was found to be a significant confounder for users of DRSP/EE with regards to DVT risk across all age groups assessed: 20<Age </= 30 (ROR = 1.33, 95% CI 1.23-1.45), 30<Age </= 40 (ROR = 2.16, 95% CI 1.98-2.35), and Age>40 (ROR = 3.69, 95% CI 3.37-4.04) However, there was only a statistically significant elevated risk in patients over 40 years of age taking NET/EE (ROR = 1.98, 95% CI 1.36-2.88). Patients that had taken DRSP/EE and the corticosteroid prednisone simultaneously had an approximately 3-fold increase in DVT risk (ROR = 2.77, 95% CI 2.43-3.15) relative to individuals that had only taken DRSP/EE. CONCLUSION: Based on this analysis, there is a higher risk of developing DVT when taking DRSP/EE than when taking NET/EE as hormonal contraception. In addition, a possibly significant drug-drug interaction between different COC formulations and prednisone were identified. This interaction may result in elevated DVT risk due to a synergistic impairment of fibrinolysis and a decrease in plasmin production. |
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| ジャーナル名 | Heliyon |
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| 投稿日 | 2024/3/4 |
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| 投稿者 | Stalas, Jennifer; Morris, Robert; Bu, Kun; von Bargen, Kevin; Largmann, Rebekah; Sanford, Kathryn; Vandeventer, Jacob; Han, Weiru; Cheng, Feng |
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| 組織名 | Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd;Tampa, FL, 33612, USA.;Department of Biostatistics and Epidemiology, College of Public Health,;University of South Florida, Tampa, FL, 33612, USA.;Department of Mathematics & Statistics, College of Art and Science, University of;South Florida, Tampa, FL, 33620, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38434341/ |
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