Endocrine Practice最新文献_第8页

Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment 生物仿制胰岛素格列宁（甘李格列宁）与原研胰岛素格列宁（Lantus®）在 1 型糖尿病患者中治疗 26 周后的免疫原性、疗效和安全性比较。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.002

Objective

To compare the immunogenicity, safety, and efficacy of Gan & Lee insulin glargine (GL Glargine) with that of the originator insulin glargine (Lantus) in patients with type 1 diabetes mellitus (T1DM).

Methods

This was a phase 3, multicenter, randomized, open-label, equivalence study. Five hundred seventy-six subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus treatment for 26 weeks. The primary end point was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody after baseline and up to visit week 26, which was evaluated using a country-adjusted logistic regression model. The study also compared the changes in glycated hemoglobin, and adverse events including hypoglycemia.

Results

The percentage of subjects positive for treatment-induced anti-insulin antibody by Week 26 was 25.8% in the GL Glargine treatment group and 25.3% in the Lantus treatment group, with a 90% confidence interval (−5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (−11.3, 11.3). The least squares mean difference between treatment groups for changes in glycated hemoglobin was −0.08 (90% confidence interval: −0.23, 0.06), and the other immunogenicity and safety profiles were comparable.

Conclusion

GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.

目的比较 GL Glargine 与参比产品（Lantus®）在 1 型糖尿病（T1DM）患者中的免疫原性、安全性和疗效：这是一项 3 期、多中心、随机、开放标签、等效性研究。576名1型糖尿病患者按1:1比例随机接受GL Glargine或Lantus®治疗，疗程26周。主要终点是基线后至第26周的各治疗组中出现治疗诱导的抗胰岛素抗体（AIA）的受试者百分比，采用国家调整的逻辑回归模型进行评估。研究还比较了糖化血红蛋白（HbA1c）的变化以及包括低血糖在内的不良事件（AEs）：到第 26 周时，GL Glargine 治疗组和 Lantus® 治疗组的治疗诱发 AIA 阳性受试者比例分别为 25.8%和 25.3%，比例差异的 90% 置信区间 [CI]（-5.4, 6.5）完全介于相似性边缘（-11.3, 11.3）之间。治疗组间 HbA1c 变化的最小二乘法（LS）平均差异为-0.08（90% CI：-0.23，0.06），其他免疫原性和安全性特征相当：GL Glargine与Lantus®相比，在对T1DM患者进行26周的治疗后，显示出相似的免疫原性、疗效和安全性。

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引用次数: 0

Determinants of Orthostatic Hypotension in Type 2 Diabetes: Is Cardiac Autonomic Neuropathy the Main Factor? 2 型糖尿病患者直立性低血压的决定因素：心脏自主神经病变是主要因素吗？

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.008

Objectives

To evaluate the determinants of orthostatic hypotension (OH) in type 2 diabetes (T2D) and the usefulness of Δheart rate (HR)/Δsystolic blood pressure (SBP), index of cardiac baroreflex function, in identifying neurogenic OH.

Methods

In 208 participants with T2D, we diagnosed early cardiovascular autonomic neuropathy (CAN) and confirmed CAN according to 1 and 2 HR-based cardiovascular reflex tests (HR-CARTs). Through OH test we defined OH as SBP falls of ≥20 and ≥30 mm Hg with supine SBPs of <140 and ≥140 mm Hg, respectively. In participants with OH, we used the lying-to-standing and OH test and its diagnostic accuracy for neurogenic OH (as OH plus confirmed HR-CAN).

Results

OH was present in 25 participants and associated with lower HR-CART scores, higher glycosylated hemoglobin level, the presence of CAN, retinopathy, and peripheral vascular disease, the absence of hypertension, and physical activity (all, P < .05) but not with interfering drugs and β-blockers. In a multiple logistic regression, HR-CAN was the main determinant of OH (odds ratio, 4.74) with physical activity and hypertension (odds ratios, 0.16 and 0.23; R² = 0.22). ΔHR/ΔSBP had a good diagnostic accuracy for neurogenic OH (area under the receiver operating characteristic curve, 0.816 ± 0.087) and, at the cutoff of 0.5 bpm/mm Hg, a sensitivity of 100% and specificity of 63.2%.

Conclusion

CAN remains the primary determinant of OH in T2D but does not explain all its variance. The index ΔHR/ΔSBP may represent a useful clinical tool to identify neurogenic OH.

目的评估 2 型糖尿病（T2D）患者正性低血压（OH）的决定因素，以及心脏气压反射功能指数 ΔHR/ΔSBP 在识别神经源性 OH 中的作用：我们对 208 名 T2D 患者进行了三种基于心率的心血管反射测试（HR-CARTs）和 OH 测试，并评估了临床病史和变量。我们将收缩压（BP）下降≥20 mmHg 和仰卧位 BP 下降≥30 mmHg 定义为 OH：25名参与者存在OH，并与较低的HR-CARTs（P=0.01）、较高的HbA1c（P=0.0048）、CAN（P=0.0058）、视网膜病变（P=0.037）和外周血管疾病（P=0.0056）、无高血压（P=0.0008）和体力活动（P=0.0214）有关，但与干扰药物和β-受体阻滞剂无关。在多元逻辑回归中，HR-CAN 是 OH 的主要独立决定因素（几率比：4.74），体育锻炼和高血压（几率比：0.16 和 0.23）（R2=0.22）。ΔHR/ΔSBP对神经源性OH具有良好的诊断准确性（AUC：0.816±0.087），以0.5 bpm/mmHg为临界值，敏感性为100%，特异性为63.2%：结论：CAN仍是T2D患者OH的主要决定因素，但并不能解释所有的变异，合并症和缺乏运动也有一定的影响。ΔHR/ΔSBP指数可能是识别神经源性OH的有用临床工具。

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引用次数: 0

Performance of Continuous Glucose Monitoring in Patients With Acute Respiratory Failure: A Prospective, Single-Center Observational Study 对急性呼吸衰竭患者进行持续葡萄糖监测：一项前瞻性单中心观察研究。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.004

Objective

Continuous glucose monitoring (CGM) may have benefits in achieving glycemic control in critically ill patients. The aim of this study was to assess the accuracy of the Freestyle Libre H (professional version similar to the Libre Pro) in patients with acute respiratory failure (ARF) in the intensive care unit (ICU).

Methods

Fifty-two adult patients with ARF were selected. The performance of CGM was evaluated using the arterial blood glucose (aBG) and point-of-care (POC) glucose levels as the reference values. Numerical accuracy was evaluated by the mean absolute relative difference, Bland-Altman analysis, %15/15 (the percentage of CGM values within 15 mg/dL or 15% of reference values <100 or >100 mg/dL, respectively), %20/20, and %30/30. Clinical accuracy was assessed using the Clarke error grid analysis.

Results

A total of 519 and 1504 pairs of aBG/CGM and POC/CGM glucose values were analyzed. The mean absolute relative difference values were 13.8% and 14.7%, respectively. The mean deviations of the Bland-Altman analysis were 0.82 mmol/L and 0.81 mmol/L. The proportions of CGM values within %15/15, %20/20, and %30/30 of the aBG values were 62.6%, 75.5%, and 92.4%, respectively; those within %15/15, %20/20, and %30/30 of the POC values were 57.1%, 72.9%, and 88.7%, respectively. The Clarke error grid analysis showed that 97.8% and 99.3% of the values were located in zone A + B. Additionally, the accuracy of CGM was not affected by general patient factors.

Conclusion

This study demonstrated that the accuracy of CGM in patients with ARF is lower than that in most outpatients and it is not affected by general patient factors. Whether CGM is beneficial to glucose management in the intensive care unit needs further evaluation.

目的：连续血糖监测（CGM）可能有助于实现重症患者的血糖控制。本研究旨在评估 Freestyle Libre H（Libre Pro 的专业版）在重症监护室（ICU）急性呼吸衰竭（ARF）患者中的准确性。以动脉血糖（aBG）和护理点（POC）血糖作为参考值，对 CGM 的性能进行了评估。数字准确性通过平均绝对相对差值 (MARD)、Bland-Altman 分析、%15/15（CGM 值在 15 mg/dL 或参考值 100mg/dL 的 15% 范围内的百分比）、%20/20 和 %30/30 进行评估；临床准确性通过克拉克误差网格分析进行评估：结果：分析了 519 对和 1504 对 aBG/CGM 和 POC/CGM 血糖值。MARD值分别为13.8%和14.7%。Bland-Altman 分析的平均偏差分别为 0.82 mmol/L 和 0.81 mmol/L。aBG值的%15/15、%20/20和%30/30分别为62.6%、75.5%和92.4%；POC值的%15/15、%20/20和%30/30分别为57.1%、72.9%和88.7%。克拉克误差网格分析显示，97.8% 和 99.3% 的数值位于（A+B）区域。此外，CGM 的准确性不受患者一般因素的影响：本研究表明，ARF 患者使用 CGM 的准确性低于大多数门诊患者，且不受一般患者因素的影响。CGM是否有利于ICU的血糖管理还需进一步评估。

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引用次数: 0

Parenteral Estradiol for Transgender Women: Time to Adjust the Dose 用于变性妇女的肠外雌二醇：是时候调整剂量了

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.07.005

引用次数: 0

Corrigendum to “Sodium-Glucose Cotransporter 2 Inhibitors Reduce the Risk of Hospitalization for Heart Failure and Amputation Rate Compared With Incretin-Based Therapy in Patients With Diabetic Foot Disease: A Nationwide Population-Based Study” [Endocrine Practice 30 (2024) 424-430] 葡萄糖钠转运体 2 抑制剂与基于胰岛素的疗法相比可降低糖尿病足病患者因心力衰竭住院的风险和截肢率：一项基于全国人口的研究》[《内分泌实践》30 (5) (2024) 第 424-430 页]。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.012

引用次数: 0

Understanding the Pharmacokinetics and Glucodynamics of Once Weekly Basal Insulins to Inform Dosing Principles: An Introduction to Clinicians 了解每周一次基础胰岛素的药代动力学和血糖动力学，为用药原则提供依据：临床医生入门指南。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.007

Objective

A new generation of basal insulin analogs enabling once-weekly administration is currently under development. Weekly basal insulins have the potential to overcome limitations exhibited by current daily basal insulins. The pharmacokinetic and glucodynamic characteristics differ significantly between weekly and daily basal insulins and will require paradigm shifts in how basal insulins are dosed.

Methods

An overview of pharmacokinetic and glucodynamic principles of basal insulins is presented. Specifically, the pharmacokinetic and glucodynamic properties of daily basal insulins and how these differ for the new weekly basal insulins are discussed. Finally, models and simulations are used to describe the impact of weekly insulin properties on dosing.

Results

Two approaches have been used to extend the half-lives of these insulins, creating fusion proteins with reduced clearance and reduced receptor-mediated degradation of the insulin. The resulting prolonged exposure-response profiles affect dosing and the impact of dosing errors. Specifically, the impact of loading doses, missed doses, and double doses, and the effect on glycemic variability of a once weekly basal insulin option are demonstrated using pharmacokinetic/glucodynamic models and simulations.

Conclusions

The transition from daily to weekly basal insulin dosing requires an understanding of the implications of the prolonged exposure-response profiles to effectively and confidently incorporate these weekly basal insulins into clinical practice. By reviewing the application of pharmacokinetic and glucodynamic principles to daily basal insulin analogs, the differences with weekly basal insulins, and the impact of these properties on dosing, this review intends to explain the principles behind weekly basal insulin dosing.

目的：目前正在开发新一代基础胰岛素类似物，可实现一周一次给药。周用基础胰岛素有可能克服目前日用基础胰岛素的局限性。周用和日用基础胰岛素的药代动力学和血糖动力学特征有很大不同，需要改变基础胰岛素的给药方式：方法：概述基础胰岛素的药代动力学和血糖动力学原理。方法：概述了基础胰岛素的药代动力学和血糖动力学原理，特别讨论了日用基础胰岛素的药代动力学和血糖动力学特性，以及这些特性与新的周用基础胰岛素有何不同。最后，使用模型和模拟来描述每周胰岛素特性对剂量的影响：结果：有两种方法可用于延长这些胰岛素的半衰期，即制造清除率降低和受体介导的胰岛素降解减少的融合蛋白。由此产生的暴露-反应曲线延长会影响剂量和剂量误差的影响。具体来说，使用药代动力学/糖动力学模型和模拟演示了负荷剂量、漏服剂量和双剂量的影响，以及每周一次基础胰岛素方案对血糖变异性的影响：结论：从每日基础胰岛素给药过渡到每周基础胰岛素给药，需要了解长期暴露-反应曲线的影响，以便有效、自信地将这些每周基础胰岛素纳入临床实践。通过回顾药代动力学和血糖动力学原理在日用基础胰岛素类似物中的应用、与周用基础胰岛素的区别以及这些特性对剂量的影响，本综述旨在解释周用基础胰岛素剂量背后的原理。

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引用次数: 0

Cardiac Autonomic Neuropathy in Graves' Disease: Smoking and Age as Predictive Factors 巴塞杜氏病的心脏自主神经病变：吸烟和年龄是预测因素。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.05.010

Objectives

Hypermetabolic state in Graves' disease (GD) has a great impact on heart homeostasis, acting directly on the heart muscle and modulating the autonomic nervous system. To characterize cardiac autonomic neuropathy (CAN) as a possible complication in patients with GD.

Methods

We evaluated euthyroid GD patients and a control group of healthy euthyroid people. CAN was assessed using autonomic tests of cardiovascular reflex and heart rate variability: respiratory, Valsalva, orthostatic and orthostatic hypotension tests, high frequency, low frequency, and very low-frequency bands. Transthoracic echocardiography was performed in GD patients.

Results

Sixty GD patients and 50 people in control group were assessed. CAN was diagnosed in 20% of GD and 14% in the control group. Among GD, 13.3% presented incipient, and 6.7% established CAN, while in the control group, it was verified incipient in 8% and established in 6% (P = .7479). All GD patients with CAN presented an alteration in the deep breathing test. Age and smoking were evidenced as factors associated with the presence of CAN, while higher TRAb values at diagnosis decreased the chance of CAN.

Conclusions

The prevalence of CAN in euthyroid GD patients was 20%. Changes in the cardiac autonomic nervous system were identified, pointing to the importance of evaluating this complication in these patients. Smoking was a predictive factor for CAN, increasing its relationship with conditions that aggravate GD.

背景：巴塞杜氏病（Graves' disease，GD）的高代谢状态直接作用于心肌并调节自主神经系统，对心脏稳态有很大影响：方法：我们对甲状腺功能正常的 GD 患者和甲状腺功能正常的健康对照组进行了评估。通过心血管反射和心率变异性的自律神经测试：呼吸测试、瓦尔萨尔瓦测试、正位和正位性低血压测试、高频、低频和极低频波段测试来评估心脏神经病变。对广东患者进行了经胸超声心动图检查：结果：对 60 名 GD 患者和 50 名对照组人员进行了评估。20%的广东患者和 14%的对照组患者被诊断出患有 CAN。在 GD 患者中，13.3% 的人有 CAN 初发症状，6.7% 的人已确诊，而在对照组中，8% 的人有 CAN 初发症状，6% 的人已确诊（P=0.7479）。所有患有 CAN 的广东籍患者在深呼吸测试中都出现了变化。年龄和吸烟被证明是与 CAN 相关的因素，而诊断时 TRAb 值越高，NAC 的几率就越低：甲状腺功能正常的广东患者中，CAN的发病率为20%。结论：在甲状腺功能正常的广东患者中，CAN的发病率为20%，发现了心脏自主神经系统的变化，这表明对这些患者的并发症进行评估非常重要。吸烟是诱发甲状腺肿大的一个因素，增加了甲状腺肿大与加重广东地区病情的关系。

{"title":"Cardiac Autonomic Neuropathy in Graves' Disease: Smoking and Age as Predictive Factors","authors":"","doi":"10.1016/j.eprac.2024.05.010","DOIUrl":"10.1016/j.eprac.2024.05.010","url":null,"abstract":"<div><h3>Objectives</h3><p>Hypermetabolic state in Graves' disease (GD) has a great impact on heart homeostasis<span>, acting directly on the heart muscle and modulating the autonomic nervous system. To characterize cardiac autonomic neuropathy (CAN) as a possible complication in patients with GD.</span></p></div><div><h3>Methods</h3><p>We evaluated euthyroid<span><span> GD patients and a control group of healthy euthyroid people. CAN was assessed using autonomic tests of </span>cardiovascular reflex<span> and heart rate variability: respiratory, Valsalva, orthostatic and orthostatic hypotension<span> tests, high frequency, low frequency, and very low-frequency bands. Transthoracic echocardiography was performed in GD patients.</span></span></span></p></div><div><h3>Results</h3><p>Sixty GD patients and 50 people in control group were assessed. CAN was diagnosed in 20% of GD and 14% in the control group. Among GD, 13.3% presented incipient, and 6.7% established CAN, while in the control group, it was verified incipient in 8% and established in 6% (<em>P</em><span><span> = .7479). All GD patients with CAN presented an alteration in the deep breathing test. Age and smoking were evidenced as factors associated with the presence of CAN, while higher </span>TRAb values at diagnosis decreased the chance of CAN.</span></p></div><div><h3>Conclusions</h3><p>The prevalence of CAN in euthyroid GD patients was 20%. Changes in the cardiac autonomic nervous system were identified, pointing to the importance of evaluating this complication in these patients. Smoking was a predictive factor for CAN, increasing its relationship with conditions that aggravate GD.</p></div>","PeriodicalId":11682,"journal":{"name":"Endocrine Practice","volume":null,"pages":null},"PeriodicalIF":3.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Effects of Implementation of European Thyroid Imaging Reporting and Data System Risk Stratification in a Thyroid Cancer Program in Western Sweden: A Retrospective Cohort Study 在瑞典西部一项甲状腺癌计划中实施欧盟-TIRADS 风险分层的影响--一项回顾性队列研究。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.05.011

Objective

The European Thyroid Imaging Reporting and Data System (EU-TIRADS) allows for selective fine needle aspiration cytology (FNAC). In 2017, EU-TIRADS was implemented as part of a nationwide standardized care bundle for thyroid cancer in Western Sweden with a population of approximately 1.7 million. The objective of this study was to investigate the clinical value of EU-TIRADS attempting to reduce the number of unnecessary FNACs in referred patients with thyroid nodules.

Methods

The study cohort consisted of all patients referred to Sahlgrenska University Hospital due to a palpable, newly detected or growing thyroid nodules or a positron emission tomography–positive finding for examination with thyroid ultrasound and selective cytology between 2018 and 2022. Medical records on EU-TIRADS classification, corresponding FNAC results, and histopathologic diagnosis were retrospectively collected. Adherence to the EU-TIRADS guidelines, use of selective FNAC, and rate of malignancy in patients who underwent surgery were assessed.

Results

In total, 1246 thyroid nodules in 990 patients were evaluated. The distributions of EU-TIRADS 2 to 5 (number [percentage]) for all examined nodules were 63 (5%), 462 (37%), 443 (36%), and 278 (22%), respectively. FNAC was omitted in 7% of the investigated patients. FNAC was performed in 124 nodules (10%) despite not fulfilling the EU-TIRADS criteria or absence of positron emission tomography–positive findings. The rate of malignancy was 33% and 1/50 in patients who underwent “unnecessary” FNAC.

Conclusion

Implementation of EU-TIRADS in routine management of thyroid nodules led to the selective use of FNAC; however, the clinical impact was limited. This study provides real-world data on the value and magnitude of diagnostic improvement by implementing EU-TIRADS in clinical practice.

简介欧盟甲状腺成像报告和数据系统（EU-TIRADS）可用于选择性细针穿刺细胞学检查（FNAC）。2017 年，EU-TIRADS 作为全国甲状腺癌标准化护理包的一部分在瑞典西部实施，该地区人口约 170 万。本研究旨在探讨EU-TIRADS在减少甲状腺结节转诊患者不必要的FNAC数量方面的临床价值：研究队列包括 2018 年至 2022 年期间因可触及、新发现或生长的甲状腺结节或 PET 阳性发现而转诊至 Sahlgrenska 大学医院接受甲状腺超声和选择性细胞学检查的所有患者。我们回顾性地收集了有关 EU-TIRADS 分类、相应的 FNAC 结果和组织病理学诊断的医疗记录。对欧盟-TIRADS指南的遵守情况、选择性FNAC的使用情况以及接受手术患者的恶变率（ROM）进行了评估：结果：共对990名患者的1246个甲状腺结节进行了评估。EU-TIRADS 2-5 n(%)的分布情况为：63(5)；462(37)；443(36)；278(22)。7%的受检患者未进行 FNAC 检查。有 124 个结节（10%）尽管不符合 EU-TIRADS 标准或没有 PET 阳性结果，但仍进行了 FNAC 检查。在接受 "不必要 "FNAC的患者中，ROM分别为33%和1/50：讨论：在甲状腺结节的常规治疗中实施欧盟-TIRADS标准导致有选择性地使用FNAC，但临床影响有限。本研究提供了真实世界的数据，说明在临床实践中实施 EU-TIRADS 可提高诊断的价值和幅度。

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引用次数: 0

Navigating the New Frontiers of Hyperglycemic Crisis Management: Unveiling the Latest American Diabetes Association Consensus Report 探索高血糖危机管理的新领域：揭开美国糖尿病协会最新共识报告的神秘面纱。

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.06.011

引用次数: 0

Ambulatory Blood Pressure Parameters Among Men With Hypogonadism Treated With Testosterone Transdermal Therapy 接受睾酮透皮疗法治疗的性腺功能减退症男性的动态血压参数

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice

Pub Date : 2024-09-01 DOI: 10.1016/j.eprac.2024.05.015

Objective

Studies are needed to examine the effects of testosterone replacement therapy on ambulatory blood pressure (BP) parameters. This study assessed a testosterone transdermal system (TTS) using 24-hour ambulatory BP monitoring.

Methods

In a single-arm, noninferiority trial conducted at 41 US sites, 168 men (mean age: 56.2 years) with hypogonadism not receiving testosterone replacement therapy in the past 6 months were enrolled and received ≥1 study drug dose. Nightly TTS treatment was administered for 16 weeks (starting dose: 4 mg/d; min, max dose: 2, 6 mg/d) to achieve testosterone concentration of 400−930 ng/dL. The primary endpoint was mean change from baseline to week 16 in 24-hour systolic BP (SBP). Noninferiority was determined based on the upper bound of the 2-sided 95% CI <3.0 mmHg.

Results

Sixty-two men had ≥85% study drug compliance and a valid week 16 ambulatory BP monitoring session. Mean change from baseline to week 16 in 24-hour average SBP was 3.5 mmHg (95% CI, 1.2−5.8 mmHg; n = 62). Since the upper limit of the CI was >3 mmHg, an effect of TTS could not be ruled out. Mean changes were larger at daytime vs nighttime and in subgroups of men with vs without hypertension. Cardiovascular adverse events were rare (<2%) and nonserious; no major cardiovascular adverse events were reported.

Conclusion

A meaningful effect of 16-week TTS treatment on 24-hour average SBP among men with hypogonadism could not be ruled out based on the study’s noninferiority criterion. The magnitude of mean changes observed may not be clinically meaningful regarding cardiovascular events.

目的：需要研究睾酮替代疗法（TRT）对动态血压（BP）参数的影响。本研究使用 24 小时动态血压监测 (ABPM) 对睾酮透皮系统 (TTS) 进行了评估：在美国 41 个研究机构进行的单臂非劣效性试验中，168 名在过去 6 个月中未接受过 TRT 治疗的性腺功能减退症男性（平均年龄：56.2 岁）参加了试验，并接受了≥1 个剂量的研究药物。夜间 TTS 治疗为期 16 周（起始剂量：4 毫克/天；最小、最大剂量：2、6 毫克/天），以达到 400-930 纳克/分升的睾酮浓度。主要终点是 24 小时收缩压 (SBP) 从基线到第 16 周的平均变化。根据双侧 95% CI 的上限确定非劣效性：62名男性的研究药物依从性≥85%，且第16周的ABPM疗程有效。24 小时平均 SBP 从基线到第 16 周的平均变化为 3.5 mmHg（95% CI，1.2-5.8 mmHg；n=62）。由于 CI 上限大于 3 mmHg，因此不能排除 TTS 的影响。白天与夜间以及患有与不患有高血压的男性亚组的平均变化更大。心血管不良事件（AEs）很少发生（结论：16 周的 TTS 有明显的效果）：根据该研究的非劣效性标准，不能排除为期 16 周的 TTS 治疗对性腺功能减退症男性患者 24 小时平均 SBP 产生有意义的影响。就心血管事件而言，观察到的平均变化幅度可能没有临床意义。

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引用次数: 0