| Title |
Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study
|
|---|---|
| Published in |
Neuropsychiatric Disease and Treatment, August 2017
|
| DOI | 10.2147/ndt.s131224 |
| Pubmed ID | |
| Authors |
Jingping Zhao, Lehua Li, Jianguo Shi, Yi Li, Xiufeng Xu, Keqing Li, Lili Zhang, Shangli Cai, Yu Feng, Jianmin Zhuo, Weihong Liu, Huafei Lu |
| Abstract |
Long-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest. The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia. In this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled. All patients received injections of PP1M 150 mg eq. (day 1) and 100 mg eq. (day 8), followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq.). Of the 353 patients, 234 (66.3%) completed the study treatment (mean age, 31.1 years; 52.7% men). The PANSS total score (primary end point) improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001). The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points) also improved significantly (P<0.0001). At 6 months, PP1M had a positive impact on medication satisfaction, adherence, and increased preference for LAIs. Treatment-emergent adverse events (TEAEs) were reported by 181 (51.3%) patients (TEAEs ≥5%: extrapyramidal disorder [15.3%], akathisia [10.5%], blood prolactin increase [8.8%], insomnia [5.4%]). A total of 8 deaths were reported, including 4 completed suicides. Long-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 45 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 45 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 6 | 13% |
| Student > Ph. D. Student | 6 | 13% |
| Student > Doctoral Student | 4 | 9% |
| Other | 3 | 7% |
| Student > Bachelor | 3 | 7% |
| Other | 6 | 13% |
| Unknown | 17 | 38% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 8 | 18% |
| Psychology | 7 | 16% |
| Biochemistry, Genetics and Molecular Biology | 3 | 7% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 4% |
| Neuroscience | 2 | 4% |
| Other | 3 | 7% |
| Unknown | 20 | 44% |
Attention Score in Context
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#20,660,571
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Outputs from Neuropsychiatric Disease and Treatment
#2,328
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Outputs of similar age from Neuropsychiatric Disease and Treatment
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