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Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison.
Int Clin Psychopharmacol. 2014 Jan; 29(1):45-55.IC

Abstract

Early in the course of illness, patients with schizophrenia may be particularly susceptible to adverse events (AEs). In this post-hoc, subgroup analysis of a 13-week, double-blind, double-dummy, multicenter study, patients recently diagnosed with schizophrenia (≤ 5 years) were administered once-monthly flexible-dose paliperidone palmitate (PP) (n=161; initiation doses, 150 mg eq day 1 and 100 mg eq day 8) [PP doses can be expressed as milligram equivalents (mg eq) of paliperidone or as milligrams (mg) of PP. 150 mg eq paliperidone=234 mg PP; 100 mg eq paliperidone=156 mg PP. In the USA, dosing tends to be expressed in mg] or oral risperidone [during initiation of risperidone long-acting injection (RLAI) days 1-28] and biweekly flexible-dose RLAI (n=173; initial injection day 8). Assessments were performed at baseline and days 4, 15, 22, 36, 64, and 92. Because of RLAI's release profile, data through day 22 correspond to oral risperidone in the RLAI arm. During this period, the AE profile and onset of efficacy of PP and oral risperidone were similar. The overall AE rates at week 13 for PP and RLAI were 54.7 and 50.3%, respectively, for any AE; 11.2 and 8.1% for extrapyramidal symptom-related AEs; and 2.5 and 2.3% for prolactin-related AEs. No significant differences in the mean weight change, most metabolic parameters, or mean efficacy measures were observed at end point. In patients with recently diagnosed schizophrenia, the tolerability and efficacy of PP and RLAI were generally similar over 13 weeks.

Authors+Show Affiliations

aMedical Affairs bMedical Information, Janssen Scientific Affairs, LLC cBiostatistics, B&P, Janssen Research & Development, LLC, Titusville, New Jersey, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24113628

Citation

Fu, Dong-Jing, et al. "Paliperidone Palmitate Versus Oral Risperidone and Risperidone Long-acting Injection in Patients With Recently Diagnosed Schizophrenia: a Tolerability and Efficacy Comparison." International Clinical Psychopharmacology, vol. 29, no. 1, 2014, pp. 45-55.
Fu DJ, Bossie CA, Sliwa JK, et al. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014;29(1):45-55.
Fu, D. J., Bossie, C. A., Sliwa, J. K., Ma, Y. W., & Alphs, L. (2014). Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. International Clinical Psychopharmacology, 29(1), 45-55. https://doi.org/10.1097/YIC.0000000000000006
Fu DJ, et al. Paliperidone Palmitate Versus Oral Risperidone and Risperidone Long-acting Injection in Patients With Recently Diagnosed Schizophrenia: a Tolerability and Efficacy Comparison. Int Clin Psychopharmacol. 2014;29(1):45-55. PubMed PMID: 24113628.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. AU - Fu,Dong-Jing, AU - Bossie,Cynthia A, AU - Sliwa,Jennifer K, AU - Ma,Yi-Wen, AU - Alphs,Larry, PY - 2013/10/12/entrez PY - 2013/10/12/pubmed PY - 2014/7/18/medline SP - 45 EP - 55 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 29 IS - 1 N2 - Early in the course of illness, patients with schizophrenia may be particularly susceptible to adverse events (AEs). In this post-hoc, subgroup analysis of a 13-week, double-blind, double-dummy, multicenter study, patients recently diagnosed with schizophrenia (≤ 5 years) were administered once-monthly flexible-dose paliperidone palmitate (PP) (n=161; initiation doses, 150 mg eq day 1 and 100 mg eq day 8) [PP doses can be expressed as milligram equivalents (mg eq) of paliperidone or as milligrams (mg) of PP. 150 mg eq paliperidone=234 mg PP; 100 mg eq paliperidone=156 mg PP. In the USA, dosing tends to be expressed in mg] or oral risperidone [during initiation of risperidone long-acting injection (RLAI) days 1-28] and biweekly flexible-dose RLAI (n=173; initial injection day 8). Assessments were performed at baseline and days 4, 15, 22, 36, 64, and 92. Because of RLAI's release profile, data through day 22 correspond to oral risperidone in the RLAI arm. During this period, the AE profile and onset of efficacy of PP and oral risperidone were similar. The overall AE rates at week 13 for PP and RLAI were 54.7 and 50.3%, respectively, for any AE; 11.2 and 8.1% for extrapyramidal symptom-related AEs; and 2.5 and 2.3% for prolactin-related AEs. No significant differences in the mean weight change, most metabolic parameters, or mean efficacy measures were observed at end point. In patients with recently diagnosed schizophrenia, the tolerability and efficacy of PP and RLAI were generally similar over 13 weeks. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/24113628/Paliperidone_palmitate_versus_oral_risperidone_and_risperidone_long_acting_injection_in_patients_with_recently_diagnosed_schizophrenia:_a_tolerability_and_efficacy_comparison_ L2 - https://doi.org/10.1097/YIC.0000000000000006 DB - PRIME DP - Unbound Medicine ER -