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Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics.
Neuropsychiatr Dis Treat. 2013; 9:341-50.ND

Abstract

BACKGROUND

This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics.

METHODS

Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25-50 mg biweekly, with oral risperidone supplementation on days 1-28), plus matched placebo injections/tablets.

RESULTS

This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from -17.5 to -19.5, all P < 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P < 0.0001).

CONCLUSION

Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.

Authors+Show Affiliations

CNS Medical Affairs, LLC, Titusville, NJ, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23493643

Citation

Alphs, Larry, et al. "Paliperidone Palmitate and Risperidone Long-acting Injectable in Subjects With Schizophrenia Recently Treated With Oral Risperidone or Other Oral Antipsychotics." Neuropsychiatric Disease and Treatment, vol. 9, 2013, pp. 341-50.
Alphs L, Bossie CA, Sliwa JK, et al. Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics. Neuropsychiatr Dis Treat. 2013;9:341-50.
Alphs, L., Bossie, C. A., Sliwa, J. K., Fu, D. J., Ma, Y. W., & Hulihan, J. (2013). Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics. Neuropsychiatric Disease and Treatment, 9, 341-50. https://doi.org/10.2147/NDT.S36438
Alphs L, et al. Paliperidone Palmitate and Risperidone Long-acting Injectable in Subjects With Schizophrenia Recently Treated With Oral Risperidone or Other Oral Antipsychotics. Neuropsychiatr Dis Treat. 2013;9:341-50. PubMed PMID: 23493643.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics. AU - Alphs,Larry, AU - Bossie,Cynthia A, AU - Sliwa,Jennifer Kern, AU - Fu,Dong-Jing, AU - Ma,Yi-Wen, AU - Hulihan,Joseph, Y1 - 2013/03/05/ PY - 2013/3/16/entrez PY - 2013/3/16/pubmed PY - 2013/3/16/medline KW - paliperidone palmitate KW - risperidone long-acting injection KW - schizophrenia SP - 341 EP - 50 JF - Neuropsychiatric disease and treatment JO - Neuropsychiatr Dis Treat VL - 9 N2 - BACKGROUND: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics. METHODS: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25-50 mg biweekly, with oral risperidone supplementation on days 1-28), plus matched placebo injections/tablets. RESULTS: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from -17.5 to -19.5, all P < 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P < 0.0001). CONCLUSION: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia. SN - 1176-6328 UR - https://www.unboundmedicine.com/medline/citation/23493643/Paliperidone_palmitate_and_risperidone_long_acting_injectable_in_subjects_with_schizophrenia_recently_treated_with_oral_risperidone_or_other_oral_antipsychotics_ L2 - https://dx.doi.org/10.2147/NDT.S36438 DB - PRIME DP - Unbound Medicine ER -
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