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A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia.
Int J Neuropsychopharmacol. 2012 Feb; 15(1):107-18.IJ

Abstract

Paliperidone palmitate (PP) is a recently (USA) approved injectable new-generation antipsychotic. This 53-wk, Phase-III double-blind study was designed to assess the non-inferiority of PP to risperidone long-acting injectable (RIS-LAI) in schizophrenia treatment. Acutely symptomatic patients (n=749), with a Positive and Negative Syndrome Scale (PANSS) total score between 60 and 120 were randomly allocated to gluteal injections of either (a) PP: 50 mg eq. on days 1 and 8, and flexible dosing [25-100 mg eq. (i.e. 39-156 mg USA dosing)] once-monthly; or (b) RIS-LAI: bi-weekly injections of 25 mg on days 8 and 22, and flexible dosing (25-50 mg) starting from day 36, with allowed oral supplementation. Patients (n=747) were 59% men, 92% white, mean (s.d.) age of 41 (11.95) yr and 45% (n=339) completed the study. Mean (s.d.) change from baseline to endpoint in PANSS total score was: -11.6 (21.22) PP; and -14.4 (19.76) RIS-LAI (per-protocol analysis set, primary measure); least-squares means difference was -2.6 (95% CI -5.84 to 0.61), with a prespecified 5-point non-inferiority margin. PP's suboptimal dosing regimen (<150 mg eq. initial dose) resulted in lower median plasma levels of the active moiety in PP-treated vs. RIS-LAI-treated patients. Insomnia was the most common treatment-emergent adverse event, with a similar incidence in both groups (15%). PP did not demonstrate comparable efficacy to RIS-LAI, which may be attributable to the initiation dosing strategy employed. Tolerability of both treatments was comparable to previous studies, with no new safety signals detected.

Authors+Show Affiliations

Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium.Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21777507

Citation

Fleischhacker, W Wolfgang, et al. "A Randomized Trial of Paliperidone Palmitate and Risperidone Long-acting Injectable in Schizophrenia." The International Journal of Neuropsychopharmacology, vol. 15, no. 1, 2012, pp. 107-18.
Fleischhacker WW, Gopal S, Lane R, et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012;15(1):107-18.
Fleischhacker, W. W., Gopal, S., Lane, R., Gassmann-Mayer, C., Lim, P., Hough, D., Remmerie, B., & Eerdekens, M. (2012). A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. The International Journal of Neuropsychopharmacology, 15(1), 107-18. https://doi.org/10.1017/S1461145711001076
Fleischhacker WW, et al. A Randomized Trial of Paliperidone Palmitate and Risperidone Long-acting Injectable in Schizophrenia. Int J Neuropsychopharmacol. 2012;15(1):107-18. PubMed PMID: 21777507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. AU - Fleischhacker,W Wolfgang, AU - Gopal,Srihari, AU - Lane,Rosanne, AU - Gassmann-Mayer,Cristiana, AU - Lim,Pilar, AU - Hough,David, AU - Remmerie,Bart, AU - Eerdekens,Marielle, Y1 - 2011/07/22/ PY - 2011/7/23/entrez PY - 2011/7/23/pubmed PY - 2015/1/23/medline SP - 107 EP - 18 JF - The international journal of neuropsychopharmacology JO - Int J Neuropsychopharmacol VL - 15 IS - 1 N2 - Paliperidone palmitate (PP) is a recently (USA) approved injectable new-generation antipsychotic. This 53-wk, Phase-III double-blind study was designed to assess the non-inferiority of PP to risperidone long-acting injectable (RIS-LAI) in schizophrenia treatment. Acutely symptomatic patients (n=749), with a Positive and Negative Syndrome Scale (PANSS) total score between 60 and 120 were randomly allocated to gluteal injections of either (a) PP: 50 mg eq. on days 1 and 8, and flexible dosing [25-100 mg eq. (i.e. 39-156 mg USA dosing)] once-monthly; or (b) RIS-LAI: bi-weekly injections of 25 mg on days 8 and 22, and flexible dosing (25-50 mg) starting from day 36, with allowed oral supplementation. Patients (n=747) were 59% men, 92% white, mean (s.d.) age of 41 (11.95) yr and 45% (n=339) completed the study. Mean (s.d.) change from baseline to endpoint in PANSS total score was: -11.6 (21.22) PP; and -14.4 (19.76) RIS-LAI (per-protocol analysis set, primary measure); least-squares means difference was -2.6 (95% CI -5.84 to 0.61), with a prespecified 5-point non-inferiority margin. PP's suboptimal dosing regimen (<150 mg eq. initial dose) resulted in lower median plasma levels of the active moiety in PP-treated vs. RIS-LAI-treated patients. Insomnia was the most common treatment-emergent adverse event, with a similar incidence in both groups (15%). PP did not demonstrate comparable efficacy to RIS-LAI, which may be attributable to the initiation dosing strategy employed. Tolerability of both treatments was comparable to previous studies, with no new safety signals detected. SN - 1469-5111 UR - https://www.unboundmedicine.com/medline/citation/21777507/A_randomized_trial_of_paliperidone_palmitate_and_risperidone_long_acting_injectable_in_schizophrenia_ L2 - https://academic.oup.com/ijnp/article-lookup/doi/10.1017/S1461145711001076 DB - PRIME DP - Unbound Medicine ER -