从两个2个月长效注射配方中产生的阿里皮普拉血度:间接比较
Matthew Harlin1, Craig Chepke2,3, Frank Larsen4
1Quantitative Pharmacology, Clinical Pharmacology, Early Phase & Translational Medicine, Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
Neuropsychiatric disease and treatment
|June 14, 2023
概括
阿里皮普拉2个月准备好使用的960毫克 (Ari 2MRTU 960) 和阿里皮普拉劳洛西尔1064毫克 (AL 1064) 是长效的注射配方. 在精神分裂症患者中,两者都在2个月的剂量间隔内维持了治疗性阿里皮普拉的血度.
科学领域:
- 药理动力学和药物新陈代谢
- 精神病学药物治疗 精神病学药物治疗
- 长效的注射配方 长效的注射配方
背景情况:
- 阿里皮普拉2个月准备使用的960毫克 (Ari 2MRTU 960) 和阿里皮普拉劳罗1064毫克 (AL 1064) 是设计用于延长释放阿里皮普拉的新型长效注射剂 (LAI) 配方.
- 这些LAI配方提供2个月的剂量间隔,可能改善精神分裂症和双相I型精神障碍的治疗坚持.
- 了解比较性药理动力学特征对于优化治疗结果和管理患者护理至关重要.
研究的目的:
- 进行间接比较阿里皮普拉的血度之间的Ari 2MRTU 960和AL 1064在多次管理后.
- 评估这些LAI配方是否在2个月的剂量间隔内保持阿里皮普拉的血度高于≥95 ng/mL的确定的最低治疗度 (Cmin).
主要方法:
- 利用了从接受Ari 2MRTU 960 (n=96) 或AL 1064 (n=28) 四次治疗的患者获得的临床试验数据.
- 确定了关键的药理动力学参数,包括平稳状态血平均度 (Cavg,ss) 和最大血度 (Cmax).
- 与≥95 ng/mL的最低治疗性阿里皮普拉度 (Cmin) 和共识指南 (100-350 ng/mL) 的药理动力学参数进行比较.
主要成果:
- 在四次使用后,Ari 2MRTU 960的平均Cavg,ss为263 (133) ng/mL,平均Cmax为342 (157) ng/mL.
- 在AL 1064中,平均Cavg,ss为140.7 (57.3) ng/mL,平均Cmax为188.8 (79.8) ng/mL.
- 两种配方均显示了阿里皮普拉的平均血度,在整个2个月的剂量间隔内保持在最低治疗度以上.
结论:
- 这种间接比较表明,Ari 2MRTU 960和AL 1064在2个月内有效保持治疗性阿里皮普拉血水平.
- 这些发现支持这些LAI配方在治疗精神分裂症和潜在的双相I障碍方面的实用性,需要进一步的临床评估.
- 维持度高于Cmin与复发风险降低有关,这凸显了持续药物暴露的重要性.
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