A retrospective cohort study of the safety of testosterone therapy in older men

老年男性睾酮治疗安全性的回顾性队列研究

基本信息

批准号：
8625433
负责人：
Maurice Alan Brookhart
金额：
$ 3.3万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-01 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8625433
关键词：
Acute Adverse event Age Blood Cardiovascular Diseases Cardiovascular system Chronic Chronic Disease Clinical Clinical Data Code Cohort Studies Cross-Over Studies Data Databases Disease Drug Formulations Drug Kinetics Event Fracture Frequencies Gel General Practices Healthcare Healthcare Common Procedure Coding System Incidence Individual Injection of therapeutic agent Insurance Intramuscular Injections Laboratories Literature Malignant neoplasm of prostate Marketing Measurement Measures Medical Records Medicare Morbidity - disease rate Myocardial Infarction Outpatients Patients Pattern Pharmaceutical Preparations Pharmacy facility Population Procedures Relative (related person)Research Research Design Risk Risk Estimate Safety Self-control as a personality trait Serious Adverse Event Shapes Statistical Methods Stroke Subgroup Supplementation Techniques Test Result Testing Testosterone Thrombosis Time United Kingdom United States base cardiovascular disorder risk cardiovascular risk factor cohort comparative men mortality novel older men older patient randomized trial secondary outcome trend

项目摘要

DESCRIPTION (provided by applicant): Increased use of testosterone supplementation among older men in recent years has caused concern about the safety of exogenous testosterone administration. New formulations and delivery mechanisms, increased direct-to-consumer marketing, and wider recognition of natural declines in testosterone levels in older age and chronic disease have all contributed to wider use of testosterone therapy, without strong evidence of benefit or assurance of safety in older men who are already at risk for morbidity and mortality. Recent randomized trials have suggested an increased risk of cardiovascular events, but the body of literature is still without conclusive evidence. Additional analyses of large populations are needed to better describe how testosterone therapy is used in real-world practice and assess the possibility that use of testosterone may increase risk of serious adverse events. We propose a large retrospective cohort study using healthcare and laboratory testing data from a large population of older men in the United States with Medicare or commercial insurance. We will also create a second cohort using clinical data from the United Kingdom's General Practice Research Database. We will study patterns of initiation relative to testosterone testing, and how prescribing has changed over time. We will use propensity score techniques to compare rates of cardiovascular events in testosterone users to those of non-users with comparable testosterone levels. We will examine the risk of bone fractures and prostate cancer as secondary outcomes. These effects will also be investigated in vulnerable subgroups (e.g. older age, chronic disease, varying levels of testosterone deficiency). We will study transient risk of acute events using a self-controlled case-crossover analysis. And finally, different testosterone delivery mechanisms (e.g. patch, gel, injections) will be compared to determine if there are differential risks among the different formulations. The results of this stuy will contribute important evidence to the growing, but yet inconclusive, body of literature surrounding the safety of exogenous testosterone use among older men.

描述（由申请人提供）：近年来老年男性补充睾丸激素的使用增加引起了人们对外源睾丸激素给药的安全性的关注。新的配方和递送机制，直接到消费者营销的增加以及对年龄较大和慢性疾病的睾丸激素水平的自然下降的广泛认识都有助于更广泛地使用睾丸激素治疗，而没有强有力的证据表明已经有发病率和死亡率的老年男性受益于老年男性的安全性。最近的随机试验表明，心血管事件的风险增加了，但文学的身体仍然没有确定的证据。需要对大量人群进行其他分析，以更好地描述如何在现实世界实践中使用睾丸激素治疗，并评估使用睾丸激素可能会增加严重不良事件的风险的可能性。我们提出了一项大型回顾性队列研究，使用来自美国大量老年男性的医疗保健和实验室测试数据，其中包括Medicare或商业保险。我们还将使用英国通用研究数据库的临床数据创建第二个队列。我们将研究相对于睾丸激素测试的起始模式，以及开处方的变化如何随时间变化。我们将使用倾向分数技术将睾丸激素使用者中心血管事件的速率与具有可比睾丸激素水平的非用户的速率进行比较。我们将研究骨折和前列腺癌的风险。这些影响还将在弱势亚组中进行研究（例如，年龄较大，慢性病，睾丸激素缺乏水平的不同）。我们将使用自我控制的案例交叉分析来研究急性事件的短暂风险。最后，将比较不同的睾丸激素递送机制（例如斑块，凝胶，注射），以确定不同配方之间是否存在差异风险。这种Stuy的结果将为围绕老年男性使用外源睾丸激素安全的文献的增长但尚无定论的文献提供重要证据。