Efficacy and safety of paliperidone palmitate versus other long-acting injectable antipsychotic drugs in the treatment of schizophrenia: a meta-analysis

Published on Feb. 18, 2024Total Views: 1019 times Total Downloads: 573 times Download Mobile

Author: ZHAO Mingjun ¹ MAO Yage ²  WANG Chuansheng ³

Affiliation: 1. Drug Clinical Trial Institution, The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Hospital), Xinxiang 453002, Henan Province, China 2. Department of Pharmacy, Xinxiang Maternal and Child Health Hospital, Xinxiang 453000, Henan Province, China 3. Department of Psychiatry, The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Hospital), Xinxiang 453002, Henan Province, China

Keywords: Paliperidone palmitate injection Long-acting injection Schizophrenia Meta-analysis Randomized controlled trial

DOI: 10.12173/j.issn.1005-0698.202312036

Reference: ZHAO Mingjun, MAO Yage, WANG Chuansheng.Efficacy and safety of paliperidone palmitate versus other long-acting injectable antipsychotic drugs in the treatment of schizophrenia: a meta-analysis[J].Yaowu Liuxingbingxue Zazhi,2024, 33(2):203-211.DOI: 10.12173/j.issn.1005-0698.202312036.[Article in Chinese]  Copied

Abstract
Full-text
References

Abstract

Objective To assess the safety of paliperidone palmitate (PP) injection versus other antipsychotic drugs long-acting injections (LAIs) in the treatment of schizophrenia.

Methods PubMed, Web of Science, Embase, Cochrane Library, PsycINFO, CNKI, SinoMed, VIP and WanFang Data databases were searched to collect randomized controlled trials (RCTs) on PP injection versus other antipsychotic drugs LAIs in the treatment of schizophrenia from the inception to April 30, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.2 software.

Results A total of 12 RCTs involving 4 368 patients were included. The results of Meta-analysis showed that there was no significant difference in clinical efficacy between PP injection treated group and risperidone LAIs treated group (P>0.05), no significant difference was found for positive and negative syndrome scale (PANSS) overall score changes between PP injection treated group and other antipsychotic drugs LAIs treated group (P>0.05). Compared with other antipsychotic LAIs treated groups, PP injection treated group had a significantly higher rate of total withdrawls (RR=1.14, 95%CI 1.06 to 1.24, P<0.01) and the incidence of adverse reactions of abnormal injection site (RR=2.08, 95%CI 1.03 to 4.22, P=0.04).

Conclusion Current evidence indicates that PP injection didn’t show significant difference in efficacy outcomes, while may increase the incidence of some adverse reactions when compared with other antipsychotic drugs LAIs for schizophrenic. However, due to the limitations of the quantity and quality of the included studies, the above conclusions still need to be validated by more high-quality studies.

Full-text

Please download the PDF version to read the full text: download

References

1.Harvey PD, Bosia M, Cavallaro R, et al. Cognitive dysfunction in schizophrenia: an expert group paper on the current state of the art[J]. Schizophr Res Cogn, 2022, 29: 100249. DOI: 10.1016/j.scog.2022.100249.

2.Jauhar S, Johnstone M, McKenna PJ. Schizophrenia[J]. Lancet, 2022, 399(10323): 473-486. DOI: 10.1016/S0140-6736(21)01730-X.

3.陆林, 主编. 沈渔邨精神病学, 第6 版[M]. 北京: 人民卫生出版社, 2018: 652.

4.Miyamoto S, Duncan GE, Marx CE, et al. Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs[J]. Mol Psychiatry, 2005, 10(1):79-104. DOI: 10.1038/sj.mp.4001556.

5.Nasrallah HA. The case for long-acting antipsychotic agents in the post-CATIE era[J]. Acta Psychiatrica Scandinavica, 2007, 115(4): 260-267. DOI: 10.1111/j.1600-0447.2006.00982.x.

6.Tiihonen J, Haukka J, Taylor M, et al. A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia[J]. Am J Psychiatry, 2011, 168(6): 603-609. DOI: 10.1176/appi.ajp.2011.10081224.

7.Stahl SM. Long-acting injectable antipsychotics: shall the last be first?[J]. CNS Spectr, 2014, 19(1): 3-5. DOI: 10.1017/S1092852913001016.

8.Whale R, Pereira M, Cuthbert S, et al. Effectiveness and predictors of continuation of paliperidone palmitate long-acting injection treatment: a 12-month naturalistic cohort study[J]. J Clin Psychopharmacol, 2015, 35(5): 591-595. DOI: 10.1097/JCP.0000000000000385.

9.Alphs L, Bossie CA, Sliwa JK, et al. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial[J]. Ann Gen Psychiatry, 2011, 10(1): 12. DOI: 10.1186/1744-859X-10-12.

10.卢瑞玲, 仲照希. 棕榈酸帕利哌酮长效针剂对精神分裂症急性期及维持期的效果[J]. 国际精神病学杂志, 2022, 49(3): 440-443. [Lu RL, Zhong ZX. Effect of paliperidone palmitate long-acting injection on schizophrenia patients in acute and maintenance stage[J]. Journal of International Psychiatry, 2022, 49(3): 440-443.] http://www.cnki.com.cn/Article/CJFDTotal-GWYJ202203007.htm.

11.黄源, 刘国恩, 高晨, 等. 棕榈酸帕利哌酮注射液治疗精神分裂症有效性和安全性的Meta分析[J]. 中国药学杂志, 2014, 49(6): 517-522. [Huang Y, Liu GE, Gao C, et al. Efficacy and safety of paliperidone palmitate in the treatment of schizophrenia: a Meta-analysis[J]. Chinese Pharmaceutical Journal, 2014, 49(6): 517-522.] DOI: 10.11669/cpj.2014.06.021.

12.Nussbaum AM, Stroup TS. Paliperidone palmitate for schizophrenia[J]. Cochrane Database of Systematic Reviews, 2012, (6): CD008296. DOI: 10.1002/14651858.CD008296.pub2.

13.Zhao MJ, Qin B, Mao YG, et al. Paliperidone palmitate versus risperidone long-acting injectable in patients with schizophrenia: a meta-analysis of efficacy and safety[J]. Neuropsychiatr Dis Treat, 2023, 5(19): 749-757. DOI: 10.2147/NDT.S407259.

14.中华医学会精神科分会, 编著. 中国精神障碍分类与诊断标准(CCMD-3), 第3版[M]. 济南: 山东科技出版社, 2001: 83-84

15.Tandon R, Gaebel W, Barch DM, et al. Definition and description of schizophrenia in the DSM-5[J]. Schizophr Res, 2013, 150(1): 3-10. DOI: 10.1016/j.schres. 2013.05.028.

16.范肖冬, 汪向东, 于欣, 主编. ICD-10精神与行为障碍分类[M]. 北京: 人民卫生出版社, 1993: 90.

17.Higgins JP, Green S. Cochrane handbook for systematic re-views of interventions (Version 5.1.0)[EB/OL]. (2012-01-05)[2019-01-01]. http://www.cochrane-handbook.org.

18.DerSimonian R, Laird N. Meta-analysis in clinical trials[J]. Control Clin Trials, 1986, 7(3): 177-188. DOI: 10.1016/0197-2456(86)90046-2.

19.Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis[J]. Stat Med, 2002, 21(11): 1539-1558. DOI: 10.1002/sim.1186.

20.何雪梅. 对比棕榈酸帕利哌酮注射液与注射用利培酮微球治疗精神分裂症的效果和安全性[J]. 临床医药文献电子杂志, 2016, 3(58): 11475-11476. [He XM. Contrast palmitic acid peary PP ketone with risperidone microsphere injection and injection for the treatment of schizophrenia, and security[J]. Electronic Journal of Clinical Medical Literature, 2016, 3(58): 11475-11476.] DOI: 10.3877/j.issn.2095-8242.2016.58.010.

21.宋国华, 杨剑虹, 卢桂华.棕榈酸帕利哌酮与注射用利培酮微球治疗精神分裂症的疗效比较[J]. 医药导报, 2016, 35(10): 1072-1075. [Song GH, Yang JH, Lu GH. Comparison of efficacy of paliperidone palmitate and risperidone for depot suspension in the treatment of schizophrenia[J]. Herald of Medicine, 2016, 35(10): 1072-1075.] DOI: 10.3870/j.issn.1004-0781.2016.10.009.

22.赵黎明. 对比棕榈酸帕利哌酮注射液与注射用利培酮微球治疗精神分裂症的效果和安全性[J]. 黑龙江医药, 2016, 29(1): 66-68. [Zhao LM. Comparison of efficacy and safety of paliperidone palmitate and risperidone for depot suspension in the treatment of schizophrenia[J]. Heilongjiang Medicine Journal, 2016, 29(1): 66-68.] DOI: 10.14035/j.cnki.hljyy.2016.01.026.

23.郭美萍, 唐京雄, 温隆青, 等. 棕榈酸帕利哌酮注射液与癸酸氟哌啶醇注射液治疗精神分裂症的疗效对比[J]. 中国医学创新, 2021, 18(4): 128-131. [Guo MP, Tang JX, Wen LQ, et al. Paliperidone palmitate injection with comparison of the efficacy of haloperidol decanoate injection in the treatment of schizophrenia[J]. Medical Innovation of China, 2021, 18(4): 128-132.] DOI: 10.3969/j.issn.1674-4985.2021.04.031.

24.Alphs L, Bossie CA, Sliwa JK, et al. Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics[J]. Neuropsychiatr Dis Treat, 2013, 9: 341-350. DOI: 10.2147/NDT.S36438.

25.Fleischhacker WW, Gopal S, Lane R, et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia[J]. Int J Neuropsychopharmacol, 2012, 15(1): 107-118. DOI: 10. 1017/S1461145711001076.

26.Li H, Rui Q, Ning X, et al. A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia[J]. Prog Neuropsychopharmacol Biol Psychiatry, 2011, 35(4): 1002-1008. DOI: 10.1016/j.pnpbp.2011.02.001.

27.McEvoy JP, Byerly M, Hamer RM, et al. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia[J]. JAMA, 2014, 311(19): 1978. DOI: 10.1001/jama.2014.4310.

28.Pandina G, Lane R, Gopal S, et al. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia[J]. Prog Neuropsychopharmacol Biol Psychiatry, 2011, 35(1): 218-226. DOI: 10.1016/j.pnpbp.2010.11.008.

29.Takekita Y, Koshikawa Y, Fabbri C, et al. Cognitive function and risperidone long-acting injection vs. paliperidone palmitate in schizophrenia: a 6-month, open-label, randomized, pilot trial[J]. BMC Psychiatry, 2016, 16(1): 1-8. DOI: 10.1186/s12888-016-0883-9.

30.Naber D, Hansen K, Forray C, et al. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia[J]. Schizophr Res, 2015, 168(1-2): 498-504. DOI: 10.1016/j.schres.2015.07.007.

31.Weiden PJ, Claxton A, Kunovac J, et al. Efficacy and safety of a 2-month formulation of aripiprazole lauroxil with 1-day initiation in patients hospitalized for acute schizophrenia transitioned to outpatient care: phase 3, randomized, double-blind, active-control ALPINE study[J]. J Clin Psychiatry, 2020, 81(3). DOI: 10.4088/JCP.19m13207.

32.Yang LP, Plosker GL. Paliperidone extended release[J]. CNS Drugs, 2007, 21(5): 417-426. DOI: 10.2165/00023210-200721050-00005.

33.Hough D, Lindenmayer JP, Gopal S, et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia[J]. Prog Neuropsychopharmacol Biol Psychiatry, 2009, 33(6): 1022-1031. DOI: 10.1016/j.pnpbp.2009.05.014.

34.Raoufinia A, Peters-Strickland T, Nylander AG, et al. Aripiprazole once-monthly 400 mg: comparison of pharmacokinetics, tolerability, and safety of deltoid versus gluteal administration[J]. Int J Neuropsychopharmacol, 2017, 20(4): 295-304. DOI: 10.1093/ijnp/pyw116.