School of Pharmacy, University of Missouri-Kansas City, Kansas City, Missouri.
Division of Pharmacotherapy, College of Pharmacy, The University of Texas at Austin, San Antonio, Texas.
J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic, has 2 initiation options: 1-day (AL NanoCrystal Dispersion [AL] injection plus 30 mg oral aripiprazole on day 1 only) and 21-day (15 mg oral aripiprazole for 21 days). This post hoc analysis assessed the safety and tolerability of both initiation approaches. We analyzed data from the first 4 weeks of 2 AL studies, one using the 1-day initiation regimen (conducted between November 2017 and March 2019) and the other using the 21-day initiation regimen (conducted between December 2011 and March 2014). Outcomes of interest during the matched 4-week period included the likelihood of adverse events (AEs), including those associated with discontinuation, rated as serious, or of special interest (injection site reactions [ISRs] and akathisia). The 1-day (n = 99) and 21-day (n = 415) initiation regimens had comparable rates of AEs (57.6% and 52.0%, respectively; most were mild), serious AEs (2.0% and 1.4%), and AEs leading to discontinuation (4.0% and 3.1%). The incidence of ISRs was 11.1% after the ALinjection (day 1) in the 1-day initiation regimen. ISR rates for the AL starting doses were 9.2% for the 1-day regimen (AL 1064 mg on day 8) and 3.9% for the 21-day regimen (AL 441 mg/882 mg on day 1). Rates of akathisia were 9.1% and 11.1% for the 1-day and 21-day regimens, respectively. One patient discontinued because of an ISR in the 21-day study, and 2 patients in the 21-day study discontinued because of akathisia. Mean changes from baseline in week 4 Positive and Negative Syndrome Scale total scores were -17.4 (1-day) and -19.5 (21-day). Four-week safety and tolerability were similar following the initiation of AL with either the 1-day or 21-day regimen, supporting the utility of both initiation regimens. Engaging patients in discussions regarding options for initiating AL may help facilitate shared decision-making and personalization of treatment for patients with schizophrenia. ClinicalTrials.gov identifiers: NCT03345979 and NCT01469039.
阿立哌唑月桂酸酯（AL）是一种长效注射用抗精神病药，有两种起始方案：1 天方案（AL 纳米晶分散体[AL]注射加第 1 天仅口服 30mg 阿立哌唑）和 21 天方案（第 1 天口服阿立哌唑 15mg，共 21 天）。本事后分析评估了两种起始方案的安全性和耐受性。我们分析了两项 AL 研究的前 4 周数据，其中一项使用 1 天起始方案（2017 年 11 月至 2019 年 3 月进行），另一项使用 21 天起始方案（2011 年 12 月至 2014 年 3 月进行）。在匹配的 4 周期间，感兴趣的结局包括不良事件（AE）的可能性，包括与停药相关的、严重的或特别关注的 AE（注射部位反应[ISR]和静坐不能）。1 天（n=99）和 21 天（n=415）起始方案的 AE 发生率相似（分别为 57.6%和 52.0%，大多数为轻度）、严重 AE（2.0%和 1.4%）和导致停药的 AE（4.0%和 3.1%）。在 1 天起始方案中，AL 注射（第 1 天）后 ISR 的发生率为 11.1%。1 天方案中 AL 的起始剂量为 1064mg 时，ISR 发生率为 9.2%；21 天方案中 AL 起始剂量为 441mg/882mg 时，ISR 发生率为 3.9%。静坐不能的发生率分别为 9.1%和 11.1%。1 天和 21 天方案各有 1 例患者因 ISR 停药，21 天方案中有 2 例患者因静坐不能停药。第 4 周时阳性和阴性综合征量表总分的平均变化分别为-17.4（1 天）和-19.5（21 天）。在 AL 起始治疗后，1 天和 21 天方案的 4 周安全性和耐受性相似，支持两种起始方案的实用性。与患者讨论开始使用 AL 的选择，可能有助于促进共同决策和患者精神分裂症的个体化治疗。临床试验注册编号：NCT03345979 和 NCT01469039。
