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Long-Term Testosterone Shows Cardiovascular Safety in Men With Testosterone Deficiency in Electronic Health Records
Yilu Lin1, Shaveta Gupta2, Lizheng Shi1
1Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA 70112, USA.
Insights
Long-term testosterone therapy (TTh) in men with testosterone deficiency (TD) showed no increased cardiovascular risk in real-world practice. This study found TTh did not elevate major adverse cardiovascular events (MACE) and improved hyperlipidemia markers.
Area of Science:
- Endocrinology
- Cardiology
- Real-world evidence
Background:
- Testosterone deficiency (TD) affects numerous men, with testosterone therapy (TTh) being a common treatment.
- Concerns exist regarding the cardiovascular (CV) safety of long-term TTh.
- Real-world data is crucial to understand the CV implications of TTh in diverse patient populations.
Purpose of the Study:
- To evaluate the association between long-term TTh and CV safety in men diagnosed with TD.
- To assess the risk of major adverse cardiovascular events (MACE) in men receiving TTh compared to those not receiving it.
- To investigate the impact of TTh on the development and progression of diabetes and hyperlipidemia.
Main Methods:
- Retrospective analysis of electronic health records from 2683 adult men with TD across three healthcare systems (2012-2023).
- Propensity score matching created a 1:1 ratio of TTh (928 patients) and non-TTh (928 patients) groups, balanced for age, race, Charlson Comorbidity Index, and baseline testosterone levels.
- Intent-to-treat analysis using Kaplan-Meier curves and Cox regressions assessed MACE, diabetes, and hyperlipidemia outcomes over a median 3-year follow-up.
Main Results:
- The cumulative incidence of MACE was comparable between TTh and non-TTh groups (P > .05).
- No statistically significant association was found between TTh use and increased CV risk (univariate HR: 1.01 [0.75-1.36]; adjusted HRs: 0.98 [0.72-1.32] and 0.93 [0.68-1.26]).
- TTh was not associated with incident diabetes but showed significant improvements in low-density lipoprotein and total cholesterol levels in patients with hyperlipidemia.
Conclusions:
- Real-world clinical practice indicates that TTh in men with TD is not linked to an elevated risk of cardiovascular events.
- Testosterone therapy demonstrates a neutral effect on major adverse cardiovascular events.
- TTh may offer benefits for lipid profiles in men with hyperlipidemia and TD.
Objective:
Our objective is to examine the association between cardiovascular (CV) safety and long-term testosterone therapy (TTh) in men with testosterone deficiency (TD) in real-world practice.
Method:
We extracted the electronic health records of 2683 adult men with TD from 3 healthcare systems from January 1, 2012, to June 30, 2023. We matched TTh and non-TTh groups in a 1:1 ratio based on age, race, Charlson Comorbidity Index, and serum testosterone level via propensity score. We used intent-to-treat analysis using Kaplan-Meier curves and Cox regressions to examine CV risk for major adverse cardiovascular events (MACE). We also explored the impact of TTh on diabetes and hyperlipidemia development and progression. We compared 928 TTh patients to 928 untreated patients with a median follow-up of 3 years for both groups.
Results:
After matching, body mass index, diastolic blood pressure, hyperlipidemia, hypertension, depression, and anxiety were statistically significant different between treatment and control cohorts. The log-rank test for the cumulative MACE incidence was comparable (P > .05). There were no statistically significant associations between TTh use and CV risk hazard ratios (HRs) in the univariate Cox regression (HR [95% CI]: 1.01 [0.75-1.36]) and Cox regressions adjusted by the preexisting MACE (HR [95% CI]: 0.98 [0.72-1.32]) and other baseline covariates (HR [95% CI]: 0.93 [0.68-1.26]). No statistically significant associations were found between TTh and diabetes. For hyperlipidemia, TTh group presented statistically significant improvement on low-density lipoprotein and total cholesterol.
Conclusion:
TTh use among men with TD was not associated with increased CV risk in real-world clinical practice.
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