Daniel R Greenberg, Taylor P Kohn, Kian Asanad, Robert E Brannigan, Joshua A Halpern
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Propensity score matching was used to match patient populations. Kaplan Meier survival analysis was used to determine the relative risk of new-onset AF and AKI within 3 years.</p><p><strong>Outcomes: </strong>New-onset AF and AKI within 3 years.</p><p><strong>Results: </strong>There were 2134 men included in each cohort after propensity score matching. Men on TRT had significantly lower testosterone (T) at the time of diagnosis compared to men not prescribed TRT (207 ± 66 ng/dL vs 246 ± 140 ng/dL, P < 0.001). Kaplan-Meier survival analysis showed a significantly increased risk of AKI among men on TRT (RR 1.53, 95% CI 1.07-2.18). However, TRT was not associated with a significantly increased risk of new-onset AF (RR 1.48, 95% CI 0.93-2.37).</p><p><strong>Clinical implications: </strong>Hypogonadal men with underlying cardiovascular risk factors or pre-existing cardiovascular disease who receive TRT may be at increased risk of AKI after starting therapy.</p><p><strong>Strengths and limitations: </strong>We evaluated a large global research database and utilized similar inclusion and exclusion to the TRAVERSE trial. However, our results are limited by the retrospective study design and reliance on documented claims data.</p><p><strong>Conclusion: </strong>Similar to the TRAVERSE trial, our study demonstrated an increased risk of AKI among men on TRT, but did not find increased risk of AF. 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We compared hypogonadal men (testosterone 100-300 ng/dL) who had a prescription for topical testosterone therapy and men who did not. Propensity score matching was used to match patient populations. Kaplan Meier survival analysis was used to determine the relative risk of new-onset AF and AKI within 3 years.</p><p><strong>Outcomes: </strong>New-onset AF and AKI within 3 years.</p><p><strong>Results: </strong>There were 2134 men included in each cohort after propensity score matching. Men on TRT had significantly lower testosterone (T) at the time of diagnosis compared to men not prescribed TRT (207 ± 66 ng/dL vs 246 ± 140 ng/dL, P < 0.001). Kaplan-Meier survival analysis showed a significantly increased risk of AKI among men on TRT (RR 1.53, 95% CI 1.07-2.18). 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引用次数: 0
摘要
研究背景评估性腺功能低下男性长期血管事件和疗效反应的睾酮替代疗法（TRAVERSE）试验的二次分析显示，睾酮替代疗法（TRT）队列中新发心房颤动（AF）和急性肾损伤（AKI）的发生率明显更高：我们利用 TriNetX 研究网络确定了一组年龄在 45-80 岁之间、符合与 TRAVERSE 试验相似的纳入标准的男性。我们比较了拥有局部睾酮治疗处方的性腺功能低下男性（睾酮 100-300 ng/dL）和没有处方的男性。我们采用倾向评分匹配法来匹配患者人群。采用卡普兰-梅耶尔生存分析法确定3年内新发房颤和AKI的相对风险：结果：3年内新发房颤和心肌梗死：结果：经过倾向得分匹配后，每个队列中共纳入了2134名男性。与未使用TRT的男性相比，使用TRT的男性在诊断时的睾酮（T）明显较低（207 ± 66 ng/dL vs 246 ± 140 ng/dL, P 临床意义：具有潜在心血管风险因素或已存在心血管疾病的性腺功能低下男性在接受TRT治疗后可能会增加发生AKI的风险：我们评估了一个大型全球研究数据库，并采用了与 TRAVERSE 试验类似的纳入和排除方法。然而，我们的研究结果受到了回顾性研究设计和依赖有据可查的索赔数据的限制：结论：与 TRAVERSE 试验类似，我们的研究表明，服用 TRT 的男性发生 AKI 的风险增加，但并未发现房颤的风险增加。然而，还需要进一步的研究来验证这些结果。
Association of testosterone replacement therapy with atrial fibrillation and acute kidney injury.
Background: Secondary analyses of the Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial revealed significantly higher rates of new-onset atrial fibrillation (AF) and acute kidney injury (AKI) in the testosterone replacement therapy (TRT) cohort.
Aim: To validate the secondary findings of the TRAVERSE trial.
Methods: We utilized the TriNetX Research Network to identify a cohort of men ages 45-80 years old who met similar inclusion criteria to the TRAVERSE trial. We compared hypogonadal men (testosterone 100-300 ng/dL) who had a prescription for topical testosterone therapy and men who did not. Propensity score matching was used to match patient populations. Kaplan Meier survival analysis was used to determine the relative risk of new-onset AF and AKI within 3 years.
Outcomes: New-onset AF and AKI within 3 years.
Results: There were 2134 men included in each cohort after propensity score matching. Men on TRT had significantly lower testosterone (T) at the time of diagnosis compared to men not prescribed TRT (207 ± 66 ng/dL vs 246 ± 140 ng/dL, P < 0.001). Kaplan-Meier survival analysis showed a significantly increased risk of AKI among men on TRT (RR 1.53, 95% CI 1.07-2.18). However, TRT was not associated with a significantly increased risk of new-onset AF (RR 1.48, 95% CI 0.93-2.37).
Clinical implications: Hypogonadal men with underlying cardiovascular risk factors or pre-existing cardiovascular disease who receive TRT may be at increased risk of AKI after starting therapy.
Strengths and limitations: We evaluated a large global research database and utilized similar inclusion and exclusion to the TRAVERSE trial. However, our results are limited by the retrospective study design and reliance on documented claims data.
Conclusion: Similar to the TRAVERSE trial, our study demonstrated an increased risk of AKI among men on TRT, but did not find increased risk of AF. However, further studies are required to validate these results.
期刊介绍：
The Journal of Sexual Medicine publishes multidisciplinary basic science and clinical research to define and understand the scientific basis of male, female, and couples sexual function and dysfunction. As an official journal of the International Society for Sexual Medicine and the International Society for the Study of Women''s Sexual Health, it provides healthcare professionals in sexual medicine with essential educational content and promotes the exchange of scientific information generated from experimental and clinical research.
The Journal of Sexual Medicine includes basic science and clinical research studies in the psychologic and biologic aspects of male, female, and couples sexual function and dysfunction, and highlights new observations and research, results with innovative treatments and all other topics relevant to clinical sexual medicine.
The objective of The Journal of Sexual Medicine is to serve as an interdisciplinary forum to integrate the exchange among disciplines concerned with the whole field of human sexuality. The journal accomplishes this objective by publishing original articles, as well as other scientific and educational documents that support the mission of the International Society for Sexual Medicine.
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