Division of Cardiology, Weill Cornell Medicine, New York, NY, United States.
Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, United States.
Br J Clin Pharmacol. 2022 Oct;88(10):4460-4473. doi: 10.1111/bcp.15442. Epub 2022 Jul 13.
Deprescribing has emerged as an important aspect of patient-centred medication management but is vastly underutilized in clinical practice. The current narrative review will describe an innovative patient-centred approach to deprescribing-N-of-1 trials. N-of-1 trials involve multiple-period crossover design experiments conducted within individual patients. They enable patients to compare the effects of two or more treatments or, in the case of deprescribing N-of-1 trials, continuation with a current treatment versus no treatment or placebo. N-of-1 trials are distinct from traditional between-patient studies such as parallel-group or crossover designs which provide an average effect across a group of patients and obscure differences between individuals. By generating data on the effect of an intervention for the individual rather than the population, N-of-1 trials can promote therapeutic precision. N-of-1 trials are a particularly appealing strategy to inform deprescribing because they can generate individual-level evidence for deprescribing when evidence is uncertain, and can thus allay patient and physician concerns about discontinuing medications. To illustrate the use of deprescribing N-of-1 trials, we share a case example of an ongoing series of N-of-1 trials that compare maintenance versus deprescribing of beta-blockers in patients with heart failure with preserved ejection fraction. By providing quantifiable data on patient-reported outcomes, promoting personalized pharmacotherapy, and facilitating shared decision making, N-of-1 trials represent a potentially transformative strategy to address polypharmacy.
在以患者为中心的药物管理中,逐渐减少药物剂量已成为一个重要方面,但在临床实践中并未得到广泛应用。本综述将描述一种创新的以患者为中心的逐渐减少药物剂量方法——N-of-1 试验。N-of-1 试验涉及在单个患者中进行的多周期交叉设计实验。它们使患者能够比较两种或更多治疗方法的效果,或者在逐渐减少药物剂量的 N-of-1 试验中,比较继续当前治疗与不治疗或安慰剂的效果。N-of-1 试验与传统的患者间研究(如平行组或交叉设计)不同,后者提供了一组患者的平均效果,掩盖了个体之间的差异。通过为个体而不是群体生成干预效果的数据,N-of-1 试验可以促进治疗的精准性。N-of-1 试验是一种特别有吸引力的策略,可以为逐渐减少药物剂量提供信息,因为当证据不确定时,它们可以为个体提供逐渐减少药物剂量的证据,从而减轻患者和医生对停止用药的担忧。为了说明逐渐减少药物剂量的 N-of-1 试验的使用,我们分享了一个正在进行的 N-of-1 试验系列的案例,该试验比较了心力衰竭射血分数保留患者中继续使用β受体阻滞剂与逐渐减少药物剂量的效果。通过提供患者报告结果的量化数据、促进个性化药物治疗和促进共同决策,N-of-1 试验代表了一种解决多种药物治疗的潜在变革性策略。