| アブストラクト | INTRODUCTION: Testosterone Cypionate (TC) is a widely prescribed anabolic steroid for male hypogonadism and gender-affirming hormone therapy. While therapeutically beneficial, concerns have emerged regarding its potential to increase the risk of serious cardiovascular adverse events, including Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), and Myocardial Infarction (MI). This study investigates the disproportionality, severity, and stratified risk of TC-related cardiovascular events using real-world pharmacovigilance data. MATERIAL AND METHODS: A retrospective analysis was conducted using the FDA Adverse Event Reporting System (FAERS). Disproportionality was evaluated using Reporting Odds Ratios (ROR) and 95% Confidence Intervals (CI) for PE, DVT, and MI associated with TC. Event severity, temporal trends, polypharmacy levels, and demographic characteristics were also assessed. Stratified analyses and comparison with alternative testosterone formulations (e.g., AndroGel) were included. RESULTS: The RORs for PE (0.039; 95% CI: 0.036-0.043) and DVT (0.133; 95% CI: 0.122- 0.145) were below 1, indicating no disproportionality. Myocardial infarction had an ROR of 0.83 (95% CI: 0.71-0.97), also below the disproportional threshold. While patients with five or more concomitant medications (polypharmacy) showed numerically higher rates of hospitalization and death, chi-square tests revealed no statistically significant associations between polypharmacy and severity for MI (p = 0.627), PE (p = 0.773), or DVT (p = 0.763). Older age groups and common co-reported cardiovascular medications (e.g., aspirin, lisinopril) were prominent across serious cases. Compared to AndroGel, TC was associated with more frequent and severe MI outcomes. DISCUSSION: Although no disproportionality signal was detected for PE, DVT, or MI, the severity of outcomes in older individuals and those with multiple medications warrants vigilant prescribing practices. Though polypharmacy was associated with higher raw frequencies of adverse outcomes, statistical testing did not confirm a significant relationship. These findings emphasize the importance of individualized cardiovascular risk assessment in TC users, particularly in older and complex patients receiving testosterone therapy. CONCLUSIONS: Based on the current FAERS data, testosterone cypionate does not appear to increase the risk of major cardiovascular events more than expected. Still, serious outcomes can and do happen, especially in patients with more complex medical histories. These results highlight the importance of evaluating each patient's individual risk and show why post-marketing surveillance remains such an important tool for tracking drug safety in real-world clinical settings. |
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| 投稿者 | Kandukuru, Abhishek; Gupta, Deepak; Sharma, Priyanka; Kandukuru, Aishwarya; Nkembo, Augustine; Sutariya, Vijaykumar; Gupta, Sheeba Varghese |
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| 組織名 | Taneja College of Pharmacy, University of South Florida, 560 Channelside Dr,;Tampa, FL 33602, United States of America.;LECOM School of Pharmacy, 5000 Lakewood Ranch Blvd, Bradenton, FL 34211, United;States of America.;University of Florida, 201 Criser Hall PO Box 114000 Gainesville, FL 32611,;United States of America. |
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