暴露于德克斯芬拉胺或芬特明/芬拉胺后的膜异常和心血管状况
J M Gardin1, D Schumacher, G Constantine
1Division of Cardiology, University of California, Irvine, USA.
JAMA
|February 7, 2001
概括
黄和芬特明/黄的使用增加了大动脉吐 (AR) 的患病率,但没有腹吐 (MR) 或严重的心脏事件. 这项研究将接受治疗的患者与对照组进行比较,以评估与这些肥胖药物相关的心血管风险.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学 是一个学科.
- 公共卫生 公共卫生
背景情况:
- 由于心脏膜异常的担忧,芬拉胺和德克斯芬拉胺被撤回.
- 之前的研究缺乏与未经治疗的对照组进行比较,限制了对药物相关风险的理解.
研究的目的:
- 为了评估心血管状况和膜异常的患者治疗肥胖症用德克斯芬拉胺或芬特明/芬弗拉胺.
- 为了比较心血管参数和厌食剂治疗受试者与匹配的未经治疗的对照组之间的心声心脏学发现.
主要方法:
- 这是一项在25个美国临床中心进行的读者盲目的,受控的研究.
- 1473名符合条件的受试者 (479名德克斯芬拉胺,455名芬特明/芬弗拉胺,539名对照) 提供了临床和心声学数据.
- 心声检查使用FDA标准评估了大动脉 (AR) 和 mitra (MR) 吐,以及门叶片的移动性和厚度.
主要成果:
- 治疗和未治疗组之间的心血管症状和征兆相似.
- 与对照组 (4,1%) 相比,在德克斯芬拉胺 (8.9%) 和芬特明/芬弗拉胺 (13.7%) 组中观察到AR患病率的显著增加.
- 在MR患病率,门小册子变化,肺动脉压力,射出分数或严重心脏事件方面没有发现显著差异.
结论:
- 根据FDA心声学标准,使用德克斯芬拉胺和芬特明/芬弗拉胺与大动脉吐发生率的增加有关.
- 这些厌食剂与额头肌吐增加或严重的心脏事件无关.
- 这些发现突出了与这些以前处方的肥胖药物相关的特定心血管风险 (AR).
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