Citrome Leslie, Dunbar Martin, McGrory James A
Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA.
Alkermes, Inc, Waltham, MA, USA.
Neuropsychiatr Dis Treat. 2025 May 14;21:1047-1055. doi: 10.2147/NDT.S510471. eCollection 2025.
The randomized, controlled Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study (NCT03345979) evaluated the efficacy and safety of aripiprazole lauroxil (AL) administered every-2-months in patients with schizophrenia. Primary results indicating significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores with AL or active control (paliperidone palmitate [PP] monthly) were reported previously. In this post hoc analysis, treatment effects based on a PANSS five-factor model were assessed.
Adult patients with an acute exacerbation of schizophrenia were enrolled as inpatients, randomized to AL (1064 mg every 2 months) or PP (156 mg monthly), discharged after 2 weeks, and then followed as outpatients through week 25. PANSS five-factor scores at baseline and weeks 4, 9, and 25 were analyzed in this post hoc analysis. Within-group changes from baseline were summarized by treatment group using the last-observation-carried-forward method for imputation; no formal testing of statistical significance was performed.
Of 200 patients randomized to AL (n=99) or PP (n=101), 99 patients (AL, n=56; PP, n=43) completed study treatment. Improvement in PANSS factor scores was observed with AL from baseline to week 25. Mean (standard error [SE]) changes at week 25 were -3.5 (0.42) (negative); -5.4 (0.56) (positive); -3.4 (0.39) (disorganized thought); -1.9 (0.32) (uncontrolled hostility/excitement); and -3.1 (0.37) (anxiety/depression). For PP, week 25 PANSS factor improvements (mean [SE]) for the negative, positive, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factors were -3.4 (0.48), -6.0 (0.49), -4.0 (0.35), -2.2 (0.30), and -3.5 (0.41), respectively.
In this post hoc analysis of patients with acutely exacerbated schizophrenia treated with AL 1064 mg every-2-months or PP 156 mg monthly, numerical improvements in PANSS five-factor scores were observed over time. These results support the primary efficacy findings based on PANSS total score and suggest that efficacy extends to these clinically important symptom domains.
随机对照的阿立哌唑月桂醇和棕榈酸帕利哌酮：起始有效性（ALPINE）研究（NCT03345979）评估了每2个月给药一次的阿立哌唑月桂醇（AL）在精神分裂症患者中的疗效和安全性。先前已报告主要结果表明，使用AL或活性对照药（每月一次棕榈酸帕利哌酮[PP]）治疗后，阳性和阴性症状量表（PANSS）总分有显著改善。在这项事后分析中，评估了基于PANSS五因素模型的治疗效果。
将精神分裂症急性加重的成年患者纳入住院患者，随机分为AL组（每2个月1064mg）或PP组（每月156mg），2周后出院，然后作为门诊患者随访至第25周。在这项事后分析中，分析了基线时以及第4、9和25周时的PANSS五因素评分。治疗组使用末次观察结转法对基线组内变化进行总结，未进行统计学显著性的正式检验。
在随机分为AL组（n = 99）或PP组（n = 101）的200例患者中，99例患者（AL组，n = 56；PP组，n = 43）完成了研究治疗。从基线到第25周，观察到AL组PANSS因子评分有所改善。第25周时的平均（标准误[SE]）变化为：阴性因子-3.5（0.42）；阳性因子-5.4（0.56）；思维紊乱因子-3.4（0.39）；敌对/兴奋失控因子-1.9（0.32）；焦虑/抑郁因子-3.1（0.37）。对于PP组，第25周时PANSS阴性、阳性、思维紊乱、敌对/兴奋失控和焦虑/抑郁因子的改善情况（均值[SE]）分别为-3.4（0.48）、-6.0（0.49）、-4.0（0.35）、-2.2（0.30）和-3.5（0.41）。
在这项对每2个月接受1064mg AL或每月接受156mg PP治疗的精神分裂症急性加重患者的事后分析中，随着时间推移观察到PANSS五因素评分有数值上的改善。这些结果支持基于PANSS总分的主要疗效结果，并表明疗效扩展到了这些临床上重要的症状领域。
