Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2016 Oct;76(16):1559-1566. doi: 10.1007/s40265-016-0645-5.
A 3-monthly formulation of intramuscular paliperidone palmitate (3-monthly paliperidone palmitate) has recently been approved for the maintenance treatment of schizophrenia in adult patients in the EU (Trevicta), following earlier approval in the USA (Invega Trinza). This narrative review discusses the clinical use of 3-monthly paliperidone palmitate in the maintenance treatment of schizophrenia in adult patients and summarizes its pharmacological properties. The efficacy of the 3-monthly paliperidone palmitate formulation as a maintenance treatment for schizophrenia has been demonstrated in well designed, phase III trials. Three-monthly paliperidone palmitate was more effective than placebo in delaying time to relapse and reducing relapse rates, and was noninferior to 1-monthly paliperidone palmitate in the proportion of patients that remained relapse-free. The 3-monthly formulation was also more effective than placebo in controlling the symptoms of schizophrenia, whilst not differing significantly from the 1-monthly formulation in terms of symptomatic control. Three-monthly paliperidone palmitate was generally well tolerated in clinical trials, with a tolerability profile consistent with that of the 1-monthly formulation. In conclusion, 3-monthly paliperidone palmitate is a useful treatment option for adult patients with schizophrenia who are adequately treated with the 1-monthly formulation, particularly for those who would prefer, or may benefit from, longer dosing intervals.
一种每三个月注射一次的棕榈酸帕利哌酮长效制剂（三月注射型帕利哌酮棕榈酸酯）最近在欧盟（善思达）获批用于精神分裂症成年患者的维持治疗，此前该药已在美国（善妥达）获批。本文综述了三月注射型帕利哌酮棕榈酸酯在精神分裂症成年患者维持治疗中的临床应用，并总结了其药理学特性。多项精心设计的 III 期试验显示，三月注射型帕利哌酮棕榈酸酯作为精神分裂症维持治疗药物具有疗效。与安慰剂相比，三月注射型帕利哌酮棕榈酸酯能更有效地延迟复发时间，降低复发率，且在无复发患者比例方面与每月注射一次的帕利哌酮棕榈酸酯相当。与安慰剂相比，三月注射型帕利哌酮棕榈酸酯在控制精神分裂症症状方面也更有效，且在症状控制方面与每月注射一次的帕利哌酮棕榈酸酯无显著差异。在临床试验中，三月注射型帕利哌酮棕榈酸酯总体耐受性良好，其耐受性与每月注射一次的帕利哌酮棕榈酸酯一致。总之，对于那些已接受每月注射一次帕利哌酮棕榈酸酯充分治疗的精神分裂症成年患者，特别是那些希望或可能受益于更长给药间隔的患者，三月注射型帕利哌酮棕榈酸酯是一种有用的治疗选择。
