Circulation:GnRH拮抗剂和激动剂的相对心血管安全性孰高孰低?

2021-10-19 Nebula MedSci原创

动脉粥样硬化性心血管疾病是前列腺癌患者死亡的主要非癌症原因,GnRH拮抗剂和激动剂都是前列腺癌雄激素剥夺疗法的重要药物,但这两类药物的相对心血管安全性一直存在争议。

动脉粥样硬化性血管疾病 (ASCVD) 是前列腺癌患者死亡的主要非癌症原因。雄激素剥夺疗法 (ADT)几十年来一直是晚期前列腺癌治疗的基石。通过不同的垂体促性腺激素释放激素 (GnRH) 受体介导机制,GnRH激动剂和拮抗剂均间接或直接抑制促黄体激素分泌,从而抑制睾酮生成。

迄今为止,与GnRH激动剂相比,GnRH拮抗剂在已知动脉粥样硬化心血管疾病的前列腺癌患者中的相对心血管安全性仍然存在争议。

这是一项国际性、多中心、前瞻性、随机化、开放标签的临床试验,招募了合并动脉粥样硬化心血管疾病的前列腺癌患者,随机(1:1)分成两组,接受GnRH拮抗剂地加瑞克GnRH激动剂亮丙瑞林干预治疗12个月。主要结局是在12个月内首次发生主要不良心血管事件(死亡、心肌梗塞或卒中的复合事件)的时间。

两组主要结局的发生率

由于入组慢于预期和主要结局事件少于预期,提前停止了招募。从2016年5月3日至2020年4月6日,从12个国家的113个地点共随机挑选招募了545位受试患者。两组患者的基线特征均衡。中位年龄为73岁,49.8%的患者为局限性前列腺癌;26.3%的患者为局部晚期前列腺癌,20.4%的患者为转移性前列腺癌。地加瑞克组和亮丙瑞林组分别有15位(5.5%)和11位(4.1%)患者发生了主要不良心血管事件(风险比 1.28, 95% CI 0.59-2.79; p=0.53)。

两组发生主要结局的时间

据了解,该试验(PRONOUNCE)是首个前瞻性对比GnRH拮抗剂与GnRH激动剂在前列腺癌患者中的心血管安全性的国际性随机临床试验。由于受试患者和终点事件少于计划数量,该研究提前终止,并且未观察到地加瑞克组或亮丙瑞林组之间的患者在 1 年时主要不良心血管事件的差异。因此,GnRH拮抗剂和激动剂的相对心血管安全性仍未能解决。

原始出处:

Renato D. Lopes, et al. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021;144:1295–1307

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