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A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia.
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 01; 35(4):1002-8.PN

Abstract

This open-label, rater-blinded, parallel-group study was designed to evaluate noninferiority of paliperidone palmitate (PP), a once-monthly injectable atypical antipsychotic, to once-biweekly risperidone long-acting injectable (RIS-LAI) in adult Chinese patients with acute schizophrenia. Eligible Chinese adults (N=452) with schizophrenia were randomized (1:1) to either PP (N=229; deltoid injections on day 1 [150 mg eq.] and day 8 [100 mg eq.]; then once-monthly deltoid or gluteal injections, flexibly dosed [50, 100, or 150 mg eq.]), or RIS-LAI (N=223; once-biweekly gluteal injections, flexibly dosed [25, 37.5 or 50 mg]). RIS-LAI-treated patients received oral risperidone supplementation (1-6 mg/day) at initiation and with RIS-LAI dose increases. Mean (SD) Positive and Negative Syndrome Scale (PANSS) total score at baseline was 83.2 (12.44). Mean (SD) change from baseline to endpoint in PANSS total scores (primary efficacy measure) was: -23.6 (16.28) for PP group and -26.9 (15.43) for RIS-LAI group. PP was noninferior to RIS-LAI (least squares mean difference [95% CI]: -2.3 [-5.20; 0.63]; predetermined non-inferiority margin: -5.5). Mean (SD) change from baseline to endpoint in Clinical Global Impression-Severity scale score was: -1.5 (1.24; PP group), -1.7 (1.16; RIS-LAI group) and in Personal and Social Performance Scale scores was: 16.8 (14.76; PP group), 18.6 (13.92; RIS-LAI group). The incidence of treatment-emergent adverse events (TEAEs) was similar between the two groups (73% [PP]; 75% [RIS-LAI]). The most common TEAEs were akathisia, tremor, and insomnia. The study demonstrated the noninferiority of PP (50-150 mg eq., flexibly dosed, without oral paliperidone supplementation) to risperidone-LAI (25-50 mg, flexibly dosed, with oral risperidone supplementation) for the treatment of acute schizophrenia in adult Chinese patients. PP injections were generally tolerable, and no new safety signals were detected in this population.

Authors+Show Affiliations

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21315787

Citation

Li, Huafang, et al. "A Comparative Study of Paliperidone Palmitate and Risperidone Long-acting Injectable Therapy in Schizophrenia." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 35, no. 4, 2011, pp. 1002-8.
Li H, Rui Q, Ning X, et al. A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(4):1002-8.
Li, H., Rui, Q., Ning, X., Xu, H., & Gu, N. (2011). A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Progress in Neuro-psychopharmacology & Biological Psychiatry, 35(4), 1002-8. https://doi.org/10.1016/j.pnpbp.2011.02.001
Li H, et al. A Comparative Study of Paliperidone Palmitate and Risperidone Long-acting Injectable Therapy in Schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):1002-8. PubMed PMID: 21315787.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. AU - Li,Huafang, AU - Rui,Qing, AU - Ning,Xiaoping, AU - Xu,Haiyan, AU - Gu,Niufan, Y1 - 2011/02/18/ PY - 2010/11/04/received PY - 2011/02/03/revised PY - 2011/02/03/accepted PY - 2011/2/15/entrez PY - 2011/2/15/pubmed PY - 2011/9/14/medline SP - 1002 EP - 8 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog Neuropsychopharmacol Biol Psychiatry VL - 35 IS - 4 N2 - This open-label, rater-blinded, parallel-group study was designed to evaluate noninferiority of paliperidone palmitate (PP), a once-monthly injectable atypical antipsychotic, to once-biweekly risperidone long-acting injectable (RIS-LAI) in adult Chinese patients with acute schizophrenia. Eligible Chinese adults (N=452) with schizophrenia were randomized (1:1) to either PP (N=229; deltoid injections on day 1 [150 mg eq.] and day 8 [100 mg eq.]; then once-monthly deltoid or gluteal injections, flexibly dosed [50, 100, or 150 mg eq.]), or RIS-LAI (N=223; once-biweekly gluteal injections, flexibly dosed [25, 37.5 or 50 mg]). RIS-LAI-treated patients received oral risperidone supplementation (1-6 mg/day) at initiation and with RIS-LAI dose increases. Mean (SD) Positive and Negative Syndrome Scale (PANSS) total score at baseline was 83.2 (12.44). Mean (SD) change from baseline to endpoint in PANSS total scores (primary efficacy measure) was: -23.6 (16.28) for PP group and -26.9 (15.43) for RIS-LAI group. PP was noninferior to RIS-LAI (least squares mean difference [95% CI]: -2.3 [-5.20; 0.63]; predetermined non-inferiority margin: -5.5). Mean (SD) change from baseline to endpoint in Clinical Global Impression-Severity scale score was: -1.5 (1.24; PP group), -1.7 (1.16; RIS-LAI group) and in Personal and Social Performance Scale scores was: 16.8 (14.76; PP group), 18.6 (13.92; RIS-LAI group). The incidence of treatment-emergent adverse events (TEAEs) was similar between the two groups (73% [PP]; 75% [RIS-LAI]). The most common TEAEs were akathisia, tremor, and insomnia. The study demonstrated the noninferiority of PP (50-150 mg eq., flexibly dosed, without oral paliperidone supplementation) to risperidone-LAI (25-50 mg, flexibly dosed, with oral risperidone supplementation) for the treatment of acute schizophrenia in adult Chinese patients. PP injections were generally tolerable, and no new safety signals were detected in this population. SN - 1878-4216 UR - https://www.unboundmedicine.com/medline/citation/21315787/A_comparative_study_of_paliperidone_palmitate_and_risperidone_long_acting_injectable_therapy_in_schizophrenia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(11)00032-7 DB - PRIME DP - Unbound Medicine ER -