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A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia.
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15; 35(1):218-26.PN

Abstract

This 13-week double-blind study was designed to assess noninferiority of the recently approved (in the U.S.) injectable atypical antipsychotic paliperidone palmitate (PP) versus risperidone long-acting injectable (RIS-LAI) in adult patients with schizophrenia. Patients (N=1220) were randomized (1:1) to either a) PP: deltoid injections on day 1 (150 mg eq.), day 8 (100 mg eq.), and once-monthly flexible dosing as deltoid or gluteal injections on day 36 (50 mg eq. or 100 mg eq.) and day 64 (50 mg eq. or 100 mg eq. or 150 mg eq.) or b) RIS-LAI: gluteal injections days 8 and 22 (25mg), days 36, 50 (25 or 37.5mg) and days 64, 78 (25, 37.5 or 50mg). RIS-LAI-treated patients received oral supplementation with RIS 1-6 mg/day (days 1 to 28), and PP-treated patients received oral placebo. The safety analysis set (n=1214) included 58% men, 78% white, with mean (SD) baseline PANSS total score: PP, 84.1 (12.09); and RIS-LAI, 83.6 (11.28). Mean (SD) change from baseline to endpoint in PANSS total score decreased similarly in both groups; PP (-18.6 [15.45]) and RIS-LAI (-17.9 [14.24]). PP treatment was noninferior to RIS-LAI (point estimate [95% CI]: 0.4 [-1.62;2.38], per-protocol analysis set [primary analysis]). The tolerability and safety of PP was generally similar to RIS-LAI with no new safety or tolerability findings.

Authors+Show Affiliations

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey 08560, USA. gpandina@its.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21092748

Citation

Pandina, Gahan, et al. "A Double-blind Study of Paliperidone Palmitate and Risperidone Long-acting Injectable in Adults With Schizophrenia." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 35, no. 1, 2011, pp. 218-26.
Pandina G, Lane R, Gopal S, et al. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(1):218-26.
Pandina, G., Lane, R., Gopal, S., Gassmann-Mayer, C., Hough, D., Remmerie, B., & Simpson, G. (2011). A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Progress in Neuro-psychopharmacology & Biological Psychiatry, 35(1), 218-26. https://doi.org/10.1016/j.pnpbp.2010.11.008
Pandina G, et al. A Double-blind Study of Paliperidone Palmitate and Risperidone Long-acting Injectable in Adults With Schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. PubMed PMID: 21092748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. AU - Pandina,Gahan, AU - Lane,Rosanne, AU - Gopal,Srihari, AU - Gassmann-Mayer,Cristiana, AU - Hough,David, AU - Remmerie,Bart, AU - Simpson,George, Y1 - 2010/11/16/ PY - 2010/07/12/received PY - 2010/10/11/revised PY - 2010/11/09/accepted PY - 2010/11/25/entrez PY - 2010/11/26/pubmed PY - 2011/5/4/medline SP - 218 EP - 26 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog Neuropsychopharmacol Biol Psychiatry VL - 35 IS - 1 N2 - This 13-week double-blind study was designed to assess noninferiority of the recently approved (in the U.S.) injectable atypical antipsychotic paliperidone palmitate (PP) versus risperidone long-acting injectable (RIS-LAI) in adult patients with schizophrenia. Patients (N=1220) were randomized (1:1) to either a) PP: deltoid injections on day 1 (150 mg eq.), day 8 (100 mg eq.), and once-monthly flexible dosing as deltoid or gluteal injections on day 36 (50 mg eq. or 100 mg eq.) and day 64 (50 mg eq. or 100 mg eq. or 150 mg eq.) or b) RIS-LAI: gluteal injections days 8 and 22 (25mg), days 36, 50 (25 or 37.5mg) and days 64, 78 (25, 37.5 or 50mg). RIS-LAI-treated patients received oral supplementation with RIS 1-6 mg/day (days 1 to 28), and PP-treated patients received oral placebo. The safety analysis set (n=1214) included 58% men, 78% white, with mean (SD) baseline PANSS total score: PP, 84.1 (12.09); and RIS-LAI, 83.6 (11.28). Mean (SD) change from baseline to endpoint in PANSS total score decreased similarly in both groups; PP (-18.6 [15.45]) and RIS-LAI (-17.9 [14.24]). PP treatment was noninferior to RIS-LAI (point estimate [95% CI]: 0.4 [-1.62;2.38], per-protocol analysis set [primary analysis]). The tolerability and safety of PP was generally similar to RIS-LAI with no new safety or tolerability findings. SN - 1878-4216 UR - https://www.unboundmedicine.com/medline/citation/21092748/A_double_blind_study_of_paliperidone_palmitate_and_risperidone_long_acting_injectable_in_adults_with_schizophrenia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(10)00423-9 DB - PRIME DP - Unbound Medicine ER -