药物开发过程中评估肥胖人群药物药代动力学和药效学的重要性。
The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development.
发表日期:2023 Nov
作者:
Kenneth T Moore, Peter N Zannikos, Joanna C Masters, Stefan Willmann, Jinshan Shen, Charles Frost
来源:
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要:
肥胖仍然是美国的国家健康危机,也是全世界日益关注的问题。令人担忧的是,肥胖者患合并症的风险增加,包括但不限于高血压、糖尿病、心血管疾病和癌症。除了发生这些疾病的风险之外,肥胖还可能影响用于治疗这些疾病和其他疾病状态的疗法的药理活性。目前上市的和临床开发中的疗法的药代动力学(PK)、药效学(PD)、安全性和有效性可能会直接受到继发于慢性体重超重的发生而发生的生理改变的影响。这种疾病患病率的增加不容忽视。参与药物研究和开发的私人和联邦机构都应酌情考虑在整个药物开发过程中更多地将肥胖个体纳入临床试验,并利用现有的 PK、PD、安全性和有效性数据,更明智的剂量建议。© 2023,美国临床药理学会。
Obesity remains a US national health crisis and a growing concern worldwide. Concerningly, individuals who are obese are at an increased risk for comorbid diseases that include, but are not limited to, hypertension, diabetes, cardiovascular disease, and cancer. Beyond the risk for developing these conditions, obesity may also impact the pharmacological activity of the therapies being used to treat them and other disease states. The pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of therapies, both currently marketed and under clinical development, may be directly impacted by the physiological alterations that occur secondary to the occurrence of chronic excess body weight. The increased prevalence of this disease should not be ignored. Both private and federal institutions involved in drug research and development should consider, as appropriate, a greater inclusion of individuals who are obese in clinical trials throughout the entirety of drug development, and leverage the available PK, PD, safety, and efficacy data to make more informed dosing recommendations.© 2023, The American College of Clinical Pharmacology.