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Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens.
Clin Schizophr Relat Psychoses. 2014 Jul; 8(2):101-9, 109A.CS

Abstract

OBJECTIVE

To examine onset of efficacy of two long-acting injectable atypical antipsychotics in markedly-to-severely ill schizophrenia subjects.

METHODS

This subgroup analysis included 292 subjects with baseline Clinical Global Impressions-Severity scores of markedly ill or worse from a 13-week, randomized, double-dummy noninferiority study (NCT00589914). Subjects received either: 1) paliperidone palmitate (PP; 234 mg day 1 and 156 mg day 8 [corresponding to 150 and 100 milligram equivalents of paliperidone, respectively], both administered in deltoid muscle, followed by once-monthly flexible dosing in deltoid or gluteal muscle) and risperidone long-acting injection (RLAI)-matched placebo injections; or, 2) RLAI (25 mg, days 8 and 22; followed by biweekly flexible dosing) and PP-matched placebo injections. RLAI subjects received oral risperidone days 1-28; PP subjects received oral placebo. Because of RLAI's release profile, data through day 22 correspond to oral risperidone. Assessments included Positive and Negative Syndrome Scale (PANSS) and adverse event (AE) reports. Paired t-tests assessed within-group changes.

RESULTS

LS mean (SE) PANSS total scores improved significantly (both p<.001) with PP and oral risperidone by day 4 (-5.0 [0.6] and -3.4 [0.6], respectively) through day 22; and with PP and RLAI through end point (-21.5 [1.9] and -18.6 [1.9], respectively). The between-group difference was significant only at day 4 (p=.006). Proportion of subjects with a .30% reduction in PANSS total score was not significantly different between the two groups at day 4 and was significantly greater with paliperidone palmitate than oral risperidone at days 15 and 22 (26.1% versus 12.7%, p=.013; 41.6% versus 32.0%, p=.048, respectively). Most common AEs (.5% in either treatment group): headache (PP 6.3% and RLAI 14.0%), insomnia (10.6% and 10.7%), somnolence (7.8% and 1.3%), akathisia (7.0% and 5.3%), schizophrenia (8.5% and 5.3%), agitation (5.6% and 2.0%), and injection site pain (5.6% and 1.3%).

CONCLUSIONS

Using the recommended dosing regimens for PP and RLAI, both PP and oral risperidone (used during RLAI initiation) improved symptoms of schizophrenia in markedly-to-severely ill subjects at days 4-22.

Authors+Show Affiliations

Janssen Scientific Affairs, LLC, Titusville, NJ, USA.Janssen Scientific Affairs, LLC, Titusville, NJ, USA.Janssen Pharmaceuticals, Titusville, NJ, USA.Johnson & Johnson Consumer Products US, Horsham, PA, USA.Janssen Scientific Affairs, LLC, Titusville, NJ, USA.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23446197

Citation

Fu, Dong-Jing, et al. "Paliperidone Palmitate Versus Risperidone Long-acting Injection in Markedly-to-severely Ill Schizophrenia Subjects: Onset of Efficacy With Recommended Initiation Regimens." Clinical Schizophrenia & Related Psychoses, vol. 8, no. 2, 2014, 101-9, 109A.
Fu DJ, Bossie CA, Kern Sliwa J, et al. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014;8(2):101-9, 109A.
Fu, D. J., Bossie, C. A., Kern Sliwa, J., Ma, Y. W., & Alphs, L. (2014). Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clinical Schizophrenia & Related Psychoses, 8(2), 101-9, 109A. https://doi.org/10.3371/CSRP.FUBO.022213
Fu DJ, et al. Paliperidone Palmitate Versus Risperidone Long-acting Injection in Markedly-to-severely Ill Schizophrenia Subjects: Onset of Efficacy With Recommended Initiation Regimens. Clin Schizophr Relat Psychoses. 2014;8(2):101-9, 109A. PubMed PMID: 23446197.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. AU - Fu,Dong-Jing, AU - Bossie,Cynthia A, AU - Kern Sliwa,Jennifer, AU - Ma,Yi-Wen, AU - Alphs,Larry, PY - 2013/3/1/entrez PY - 2013/3/1/pubmed PY - 2015/5/12/medline KW - Comparative KW - Efficacy KW - Initiation Regimens KW - Markedly Ill KW - Onset KW - Paliperidone Palmitate KW - Risperidone Long-Acting KW - Schizophrenia SP - 101-9, 109A JF - Clinical schizophrenia & related psychoses JO - Clin Schizophr Relat Psychoses VL - 8 IS - 2 N2 - OBJECTIVE: To examine onset of efficacy of two long-acting injectable atypical antipsychotics in markedly-to-severely ill schizophrenia subjects. METHODS: This subgroup analysis included 292 subjects with baseline Clinical Global Impressions-Severity scores of markedly ill or worse from a 13-week, randomized, double-dummy noninferiority study (NCT00589914). Subjects received either: 1) paliperidone palmitate (PP; 234 mg day 1 and 156 mg day 8 [corresponding to 150 and 100 milligram equivalents of paliperidone, respectively], both administered in deltoid muscle, followed by once-monthly flexible dosing in deltoid or gluteal muscle) and risperidone long-acting injection (RLAI)-matched placebo injections; or, 2) RLAI (25 mg, days 8 and 22; followed by biweekly flexible dosing) and PP-matched placebo injections. RLAI subjects received oral risperidone days 1-28; PP subjects received oral placebo. Because of RLAI's release profile, data through day 22 correspond to oral risperidone. Assessments included Positive and Negative Syndrome Scale (PANSS) and adverse event (AE) reports. Paired t-tests assessed within-group changes. RESULTS: LS mean (SE) PANSS total scores improved significantly (both p<.001) with PP and oral risperidone by day 4 (-5.0 [0.6] and -3.4 [0.6], respectively) through day 22; and with PP and RLAI through end point (-21.5 [1.9] and -18.6 [1.9], respectively). The between-group difference was significant only at day 4 (p=.006). Proportion of subjects with a .30% reduction in PANSS total score was not significantly different between the two groups at day 4 and was significantly greater with paliperidone palmitate than oral risperidone at days 15 and 22 (26.1% versus 12.7%, p=.013; 41.6% versus 32.0%, p=.048, respectively). Most common AEs (.5% in either treatment group): headache (PP 6.3% and RLAI 14.0%), insomnia (10.6% and 10.7%), somnolence (7.8% and 1.3%), akathisia (7.0% and 5.3%), schizophrenia (8.5% and 5.3%), agitation (5.6% and 2.0%), and injection site pain (5.6% and 1.3%). CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and oral risperidone (used during RLAI initiation) improved symptoms of schizophrenia in markedly-to-severely ill subjects at days 4-22. SN - 1941-2010 UR - https://www.unboundmedicine.com/medline/citation/23446197/Paliperidone_palmitate_versus_risperidone_long_acting_injection_in_markedly_to_severely_ill_schizophrenia_subjects:_onset_of_efficacy_with_recommended_initiation_regimens_ L2 - https://ClinicalTrials.gov/search/term=23446197 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -