Epidemiology and Biostatistics, CUNY School of Public Health, Hunter College, New York, NY, USA.
Eur J Clin Invest. 2015 May;45(5):475-84. doi: 10.1111/eci.12431.
Pharmacologic androgen deprivation therapy (ADT) is widely used to treat prostate cancer. Observational studies suggest ADT is associated with cardiovascular disease and its risk factors; however, such studies may be subject to bias. Our objective was to evaluate the effect of ADT on cardiovascular disease risk factors using data from randomized controlled trials (RCTs).
We conducted a systematic review using MEDLINE and MEDLINE In-Process (1950-June 2013), EMBASE (1974-June 2013) and Web of Science (1900-June 2013) for all RCTs in men with prostate cancer that compared pharmacologic ADT (i.e. use of gonadotropin-releasing hormone agonist or antagonist) with a group that did not receive ADT and reported data on cardiovascular disease risk factors including blood pressure, cholesterol, triglycerides, fibrinogen, biomarkers of insulin sensitivity, adiposity and C-reactive protein. We also searched for ongoing or unpublished trials. This study was registered at the PROSPERO International Prospective Register of Systematic Reviews (CRD42013005035).
Of the 3272 unique publications identified in our systematic review, we did not identify a single RCT that reported data on any cardiovascular disease risk factor. We were unable to locate unreported data from corresponding authors or study sponsors.
There is a lack of published, reliable evidence describing the effects of ADT on cardiovascular disease risk factors. RCTs have likely collected data on these risk factors as part of routine study monitoring; however, these data have not been published. To understand the effect of ADT on cardiovascular morbidity, these data must be made available to the scientific community.
药物去势治疗(ADT)被广泛用于治疗前列腺癌。观察性研究表明 ADT 与心血管疾病及其危险因素有关;然而,这些研究可能存在偏倚。我们的目的是使用随机对照试验(RCT)的数据来评估 ADT 对心血管疾病危险因素的影响。
我们使用 MEDLINE 和 MEDLINE In-Process(1950 年-2013 年 6 月)、EMBASE(1974 年-2013 年 6 月)和 Web of Science(1900 年-2013 年 6 月)进行了系统评价,纳入了所有比较前列腺癌男性药物去势治疗(即使用促性腺激素释放激素激动剂或拮抗剂)与未接受 ADT 且报告心血管疾病危险因素数据的 RCT,包括血压、胆固醇、甘油三酯、纤维蛋白原、胰岛素敏感性生物标志物、肥胖和 C 反应蛋白。我们还搜索了正在进行或未发表的试验。这项研究在 PROSPERO 国际前瞻性系统评价注册库(CRD42013005035)进行了注册。
在我们的系统评价中,从 3272 篇独特的文献中,我们没有发现一项 RCT 报告了任何心血管疾病危险因素的数据。我们无法从相应的作者或研究赞助商那里找到未报告的数据。
缺乏关于 ADT 对心血管疾病危险因素影响的已发表的、可靠的证据。RCT 可能已经收集了这些危险因素的数据作为常规研究监测的一部分;然而,这些数据尚未发表。为了了解 ADT 对心血管发病率的影响,必须向科学界提供这些数据。