Mathews Maju, Gopal Srihari, Singh Arun, Nuamah Isaac, Pungor Katalin, Tan Wilson, Soares Bernardo, Kim Edward, Savitz Adam J
Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.
Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.
Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.
To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).
Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.
In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M <PP1M <paliperidone and ER, in both the active treatment (PP3M, 9% <PP1M, 18% <paliperidone ER, 22%) and placebo (PP3M, 29% <PP1M, 48% <paliperidone ER, 52%) groups. The post-discontinuation median-time-to-relapse was significantly longer with PP3M (395 days [274 days to "not-reached"])> PP1M (172 days [134-222 days])> paliperidone ER (58 days [42-114 days]) and was "not-estimable" in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P<0.001]).
The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence. paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).
精神分裂症患者中，突然停用抗精神病药物治疗的情况很常见。与短效制剂相比，长效制剂停药的患者复发率可能更低。
比较三种不同剂型的帕利哌酮（口服帕利哌酮缓释片[paliperidone ER]、帕利哌酮棕榈酸酯每月一次注射剂[PP1M]和帕利哌酮棕榈酸酯每三个月一次注射剂[PP3M]长效注射剂）在活性组（类似于实际治疗中依从性好的患者）和安慰剂组（类似于实际治疗中依从性差的患者）之间的复发率和复发时间。
分析了三项针对成年精神分裂症患者设计相似的随机预防复发研究的数据。
总共纳入了922例患者（活性治疗组：473例，安慰剂组：449例）。在活性治疗组（PP3M，9%＜PP1M，18%＜paliperidone ER，22%）和安慰剂组（PP3M，29%＜PP1M，48%＜paliperidone ER，52%）中，经历复发的患者比例均为PP3M＜PP1M＜paliperidone ER。停药后复发的中位时间，PP3M（395天[274天至“未达到”]）＞PP1M（172天[134 - 222天]）＞paliperidone ER（58天[42 - 114天]），且由于活性治疗组复发率低，复发时间“无法估计”。三种帕利哌酮剂型相对于各自安慰剂的风险比（HR）为PP3M（[HR：3.81；95%CI：2.08，6.99；P＜0.0001]）＞PP1M（[HR：3.60；95%CI：2.45，5.28；P＜0.0001]）＞paliperidone ER（[HR：2.83；95%CI：1.73，4.6；P＜0.001]）。
在活性治疗期间复发率较低，且使用长效抗精神病药物制剂停药后复发时间较长，这表明长效制剂优于短效制剂，尤其是对于那些容易出现依从性差的患者。帕利哌酮ER（NCT00086320）、PP1M（NCT00111189）和PP3M（NCT01529515）。
