马西坦/塔达拉菲尔单片剂组合治疗肺动脉高血压的随机试验
Ekkehard Grünig1, Pavel Jansa2, Fenling Fan3
1Thoraxklinik at Heidelberg University Hospital and Translational Lung Research Center, German Center for Lung Research, Heidelberg, Germany.
与单独治疗相比,马西坦和塔达拉菲尔 (M/T FDC) 的固定剂量组合显著降低了肺动脉高血压 (PAH) 患者的肺血管抵抗. 这种单片剂方案为PAH提供了一种简化治疗选择.
科学领域:
- 心脏病学 心脏病学
- 肺部医学 肺部医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 建议对肺动脉高血压 (PAH) 进行结合治疗,使用内甲素受体对抗剂 (ERA) 和化酶5抑制剂 (PDE5i).
- 一个固定剂量组合 (FDC) 的马西 (ERA) 和塔达拉菲尔 (PDE5i) 在一个单片机提供简化治疗PAH患者.
研究的目的:
- 在PAH患者中,与单一疗法相比,研究马西和塔达拉菲尔 (M/T FDC) 固定剂量组合的疗效和安全性.
- 为了评估M/T FDC在以前未接受过治疗和先前接受过治疗的PAH患者中.
主要方法:
- 一项多中心,双盲,适应性第三期研究 (A DUE) 随机对187名PAH患者进行了随机选择 (WHO功能类别II-III).
- 患者接受了M/T FDC,macitentan单疗法或tadalafil单疗法.
- 主要终点是16周肺血管阻力 (PVR) 的变化.
主要成果:
- 与马西 (29%) 和塔达拉菲尔 (28%) 单一治疗相比,M/T FDC 显示PVR 降低显著更大.
- 导致停药的不良事件和严重的不良事件在M/T FDC中更频繁.
- 在M/T FDC手臂中发生了三起死亡,被认为与治疗无关.
结论:
- 固定剂量的马西坦和塔达拉菲尔组合显著改善了PAH患者的PVR,而不是单一治疗.
- M/T FDC表现出与其单个组件一致的安全性和耐受性概况.
- 该研究支持M/T FDC作为初始PAH治疗和治疗升级的单片药片选择.
更多相关视频
00:05A Semi-Quantitative Drug Affinity Responsive Target Stability DARTS assay for studying Rapamycin/mTOR interaction
Published on: August 27, 2019
07:38Comprehensive Echocardiographic Assessment of Right Ventricle Function in a Rat Model of Pulmonary Arterial Hypertension
Published on: January 20, 2023
相关概念视频
Treatment for Pulmonary Arterial Hypertension: Phosphodiesterase Inhibitors
Among the PDE5 inhibitors, sildenafil (Revatio) stands out as a competitive and selective inhibitor. It operates by elevating cellular levels of cGMP and augmenting signaling through the cGMP-PKG pathway, promoting vasodilation. Upon oral...
Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers
TKIs, such as imatinib (Gleevec), are particularly effective in tackling the growth and mitogenic factors that become upregulated in PAH patients. These factors contribute to the...
Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme...
Treatment for Pulmonary Arterial Hypertension: Prostacyclin Receptor Agonists
These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...
Pulmonary Tuberculosis V
Latent tuberculosis infection occurs when TB bacteria are present in a person's body, but are not causing illness or symptoms. It is not contagious, and preventive treatment is crucial to avoid the...
Combination Therapies and Personalized Medicine
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
