Long-term effectiveness of flexibly dosed paliperidone extended-release: comparison among patients with schizophrenia switching from risperidone and other antipsychotic agents

Abstract

Objective:

The current study compared the long-term effectiveness, safety, and tolerability of paliperidone extended-release (ER) among patients with schizophrenia who had switched from risperidone (risperidone group) or other antipsychotic medications (non-risperidone group) due to lack of efficacy, intolerability, or non-adherence.

Research design and methods:

This open-label, prospective, multicenter, 48 week study utilized the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression–Severity scale (CGI-S), the Personal and Social Performance scale (PSP), and the Subjective Well-being under Neuroleptics scale (SWN) to assess patients with schizophrenia. Additionally, extrapyramidal symptoms (EPS) and subjective side effects were evaluated with validated scales.

Clinical trial registration:

Clinicaltrials.gov identifier: NCT00864045.

Results:

The completion rate for this study was 51.6% (95/184), and 169 patients finished with ≥1 post-baseline assessment (81 patients in the risperidone group, 88 in the non-risperidone group). The mean (SD) PANSS total score decreased significantly from 78.3 (18.8) to 65.5 (19.7) in the risperidone group and from 79.1 (19.8) to 65.4 (20.8) in the other group (all p < 0.001). Similar to PANSS, the severity rating for overall scores of the CGI-S and the PSP scores improved significantly from baseline (all p < 0.001). The magnitude of improvement in all effectiveness measures at 48 weeks did not differ between the two groups. EPS and subjective side effects improved significantly for all patients. Akathisia (18.5%) and increased weight (14.1%) were the main adverse events. Elevated prolactin levels were identified in female subjects in the non-risperidone group.

Conclusions:

Switching from previously unsuccessful antipsychotic treatments to paliperidone ER can be a useful option to achieve long-term improvement in symptoms and functioning for patients with schizophrenia. The clinical effectiveness appeared to be similar in patients who previously received risperidone and those treated with other antipsychotic medications. The open-label design and lack of a placebo group were limitations.

Keywords::

• Long-term effectiveness
• Paliperidone extended-release
• Risperidone
• Schizophrenia

Transparency

Declaration of funding

This study was supported by a grant from Janssen Korea Co. Ltd. Overall data acquisition, statistical analyses, and interpretation of the study results were implemented with no input from the pharmaceutical company. All the authors contributed to interpretation of the results and drafting of the manuscript. All the authors reviewed and approved the final version of the manuscript.

Declaration of financial/other relationships

Y.M.A. received research grants and served as a lecturer for AstraZeneca, GlaxoSmithKline, Janssen, Lilly, Lundbeck, Otsuka, Pfizer, and Servier. Y.S.K. has received grants, research support, and/or honoraria from Novartis, Janssen, Eli Lilly, Pfizer, Sanofi-Aventis, Otsuka, AstraZeneca, Organon, GlaxoSmithKline, and Servier. E.Y.K., S.M.C., J.C.S., E.J.J.,and J.J.K. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors wish to acknowledge that the study design, data collection and manuscript reviewing were provided by the following investigators in the development and submission of this study: Dr Dong Chung Jung (Seoul National University Hospital, Seoul), Dr Se Hyun Kim (Medical Research Institute, Seoul National University, Seoul), Dr Sang Hyuk Lee (CHA Bundang Medical Center, Seongnam), Dr Young Chul Chung (Chonbuk National University Medical School, Jeonju), Dr Won Kim (Seoul Paik Hospital, Seoul), Dr Dong Yul Oh (Mindheal Clinic, Seoul), Dr In Won Chung (Dongguk University International Hospital, Goyang), Dr Jung Jin Kim (Seoul St. Mary’s Hospital, Seoul), Dr Jung Seo Yi (Kangnam Sacred Heart Hospital, Seoul), Dr Chul Eung Kim (Inha University Hospital, Incheon), Dr Jin Sang Yoon (Chonnam National University Medical School, Gwangju).