(014) Testosterone Therapy in Females Is Not Associated with Increased Cardiovascular Risk – A US Claims Database Analysis

Abstract

Abstract Introduction Testosterone therapy (TT) has been shown to improve libido in females with sexual dysfunction; however, utilization of TT has been limited in part due to concern for increased cardiovascular risk. Objective Our objective was to assess the association of TT in females with major adverse cardiac events (MACE) using a large claims database. Methods A US-based claims database (TriNetX Diamond Network) of over 200 million patients was queried from 2009 to 2022. Our study cohort included adult (18+) females with three or more injectable or topical testosterone prescriptions excluding those with heart failure (ICD-10 I50), unstable angina (I20.0), intersex surgery female to male (CPT 55980), personal history of sex reassignment (Z87.890), and gender identity disorders (F64). Our control cohort excluded females with any testosterone prescriptions, heart failure, intersex surgery female to male, personal history of sex reassignment, gender identity disorder, unstable angina, polycystic ovary syndrome (E28.2), or androgen excess (E28.1). Propensity-matching between the cohorts was performed for age, ethnicity, race, estrogen usage (HS300), family history of cardiovascular disease (Z82.4), tobacco usage (Z72.0), type 2 diabetes (E11), hyperlipidemia (E78), hypertensive diseases (I10-16), and utilization of outpatient (1013626), inpatient (1013659), or emergency department services (1013711). MACE was defined as heart attack (I21, I22), stroke (I60, I61, I62, I63), or death within three years of the index event. We evaluated the association of TT to MACE, upper or lower emboli or DVT (I82.4, I82.6), pulmonary embolism (PE) (I26), breast neoplasm (C50), and hirsutism (L68.0). A sub-analysis by age-based stratification (18-55-year-old and >55-year-old) was also conducted. Results Adult females with ≥3 testosterone prescriptions (n=8,457) were compared to an equivalent number of propensity-score matched controls (Table 1). Compared to matched controls, those with testosterone prescriptions had similar odds of MACE (odds ratio (OR) 0.80 [95% CI 0.60, 1.07]) and PE (OR 0.77 [0.41, 1.46]); significantly lower odds of upper or lower emboli or DVT (OR 0.59 [0.35, 0.99]) and breast neoplasm (OR 0.43 [0.32, 0.59]); and higher odds of hirsutism (OR 2.34 [1.28, 4.29]). This trend remained in the age 18-55 years group (n=5,951): MACE (OR 0.67 [0.37, 1.21]), breast neoplasm (OR 0.41 [0.24, 0.70]), and hirsutism (OR 1.45 [0.79, 2.64]) (Table 2). A similar trend was observed amongst >55-year-olds (n=2,582): MACE (OR 1.18 [0.81, 1.72]), upper or lower emboli or DVT (OR 0.89 [0.45, 1.75]), and breast neoplasm (OR 0.49 [0.33, 0.72]) (Table 2). Odds ratios could not be calculated for any patient counts less than 10 (Table 2). Conclusions In this large claims-based analysis, we showed systemic TT in women does not increase the odds of MACE or PE, and is protective against upper and lower emboli or DVTs and breast neoplasm. Our results suggest that TT in women may be safe, enabling physicians to provide appropriate therapy to women with sexual dysfunction. Disclosure No