BIO101在萨尔科佩尼克老年人中的移动障碍风险:双盲随机干预阶段2b试验的结果
Roger A Fielding1, Michael M Dao2, Kevin Cannon3
1Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts, USA.
Journal of cachexia, sarcopenia and muscle
|March 3, 2025
概括
BIO101 (20-hydroxyecdysone) 在治疗肉症方面表现有前途,这是导致流动性丧失的肌肉疾病. 萨拉-INT试验发现,350毫克的剂量改善了老年人的步行速度,具有良好的安全性,需要进一步研究.
科学领域:
- 老年学是指老年学的学科.
- 药理学 药理学是指药理学的学科.
- 肌肉生理学 肌肉生理学
背景情况:
- 萨科佩尼亚是一种渐进的肌肉疾病,导致行动障碍,目前的治疗方法仅限于炼和营养.
- 目前没有药物干预措施被批准用于麻症.
- BIO101 (20-hydroxyecdysone) 是一种MAS受体激活剂,研究了它在治疗肉症方面的潜力.
研究的目的:
- 为了评估BIO101在改善肌肉功能和身体表现的安全性和有效性,在老年人与肉类.
- 评估BIO101对步行速度和其他身体性能指标的影响.
主要方法:
- 一个随机的,三臂,安慰剂对照试验 (SARA-INT) 涉及233名社区居住的老年肉患者 (年龄≥65岁).
- 参与者接受了BIO101 (175毫克或350毫克每天两次) 或安慰剂6-9个月.
- 主要终点是步行速度的变化 (400米步行测试);次要终点包括其他身体性能测试.
主要成果:
- 与安慰剂相比,350mg的BIO101剂量显示出改善步行速度的趋势 (0.09m/s在每条协议分析中,p=0.008).
- 在具有较高移动障碍风险的特定子群体中观察到积极影响.
- 在两种测试剂量下,BIO101表现出了有利的安全性.
结论:
- 每天两次服用350毫克的BIO101显示出了临床相关的趋势,改善了sarcopenic患者的步行速度,接近临床重要的最小差异.
- 药物耐受性很好,支持其进一步开发用于治疗肉症.
- 这些第二阶段的研究结果鼓励继续对BIO101进行针对肉类的研究.
相关概念视频
Bioavailability Study Design: Healthy Subjects Versus Patients
248
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
248
Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Absorption
861
As individuals age, their body's physiology evolves, affecting drug pharmacokinetics. The most apparent changes occur in the gastrointestinal tract, where an increase in gastric pH, a delay in gastric emptying, and a reduction in gastrointestinal motility are observed. Remarkably, these changes do not substantially modify the absorption of orally administered drugs, particularly those absorbed via passive diffusion.Transdermal drug delivery emerges as a highly viable method for older adults due...
861
Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Metabolism
400
Geriatric patients show significant variation in how their bodies process medications, which can change how effective and safe treatments are. The liver is the primary organ where drug metabolism occurs, involving two main types of chemical reactions: phase I and II. Phase I metabolism is driven by the cytochrome P450 enzyme system, which includes key types such as CYP3A, CYP2D6, and CYP2C9. Research indicates that while aging doesn't notably alter the levels or activity of these enzymes, it...
400
Pharmacodynamics in Geriatric Patients: Effects of Age
367
Age-related pharmacokinetic changes are extensively documented, but understanding age-related pharmacodynamic alterations is relatively limited. This knowledge gap can be partly attributed to the complexity of developing appropriate measures of drug responses compared to bioanalytical methods for determining drug concentrations.Most information regarding age-related differences in human pharmacodynamics originates from cross-sectional studies. However, these studies assume that observed mean...
367


