恩帕格利弗洛辛的安全性:来自四项大型试验的个人参与者级数据元分析
Christoph Wanner1, Hristo Iliev2, Nathalia Duarte2
1University Hospital Würzburg, Würzburg, Germany. Wanner_C@ukw.de.
Advances in therapy
|May 21, 2024
概括
恩帕格利弗洛辛是一种2型糖尿病药物,在各种患者群体中显示出良好的安全性,包括心力衰竭和脏疾病患者. 这项分析证实了长期使用中的耐受性和安全性.
科学领域:
- 心脏病学 心脏病学
- 腎臟病學 (nephrology) 是一種醫學專業.
- 内分泌学 在内分泌学.
背景情况:
- 恩帕格利弗洛辛是一种-葡萄糖共运输体-2抑制剂,用于治疗2型糖尿病,降低心血管死亡风险,心力衰竭和慢性病.
- 虽然其安全性已有证据,但对不良事件的持续评估对于临床实践至关重要.
研究的目的:
- 为提供最新的empagliflozin安全评估.
- 评估empagliflozin在不同患者群体和疾病中的安全性.
主要方法:
- 来自四项长期临床试验的数据汇总:EMPA-REG OUTCOME (T2D与心血管疾病),EMPEROR-减少/保存 (HF) 和EMPA-脏 (CKD).
- 分析侧重于empagliflozin 10 mg剂量,因为它在选定的试验中的流行率.
主要成果:
- 在empagliflozin和安慰剂组之间,严重,致命和停药相关的不良事件的发生率相似.
- 女性严重尿路感染的发病率增加;酸和体积消耗的轻微增加.
- 严重急性损伤减少;严重低血糖,骨折或截肢的风险没有增加.
- 恩帕格利弗洛辛在各种人群中显示出安全性,包括没有糖尿病的人群,老年人以及低eGFR或BMI的患者.
结论:
- 分析证实了已确定的empagliflozin的安全性和耐受性.
- 长期安全数据支持在适合患者群体中使用empagliflozin.
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