title: A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia.
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.affiliation: Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: W Wolfgang
authors.initials: WW
authors.lastname: Fleischhacker
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Srihari
authors.initials: S
authors.lastname: Gopal
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Rosanne
authors.initials: R
authors.lastname: Lane
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Gassmann-Mayer
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: Pilar
authors.initials: P
authors.lastname: Lim
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
authors.forename: David
authors.initials: D
authors.lastname: Hough
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Remmerie
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium.
authors.forename: Marielle
authors.initials: M
authors.lastname: Eerdekens
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002081:Buttocks; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007555:Isoxazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D000068882:Paliperidone Palmitate; D010168:Palmitates / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D016896:Treatment Outcome; D044465:White People
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D010168:Palmitates; D018967:Risperidone; D000068882:Paliperidone Palmitate