| Title |
Efficacy and safety of paliperidone palmitate three-monthly formulation in East Asian patients with schizophrenia: subgroup analysis of a global, randomized, double-blind, Phase III, noninferiority study
|
|---|---|
| Published in |
Neuropsychiatric Disease and Treatment, August 2017
|
| DOI | 10.2147/ndt.s134287 |
| Pubmed ID | |
| Authors |
Adam J Savitz, Haiyan Xu, Srihari Gopal, Isaac Nuamah, Paulien Ravenstijn, David Hough, Maju Mathews, Yu Feng, Lu Yu, Masayoshi Takahashi, Dennis Liu, Gang Wang, Jin-Sang Yoon, Jiahn-Jyh Chen |
| Abstract |
To demonstrate the efficacy and safety of paliperidone palmitate three-monthly (PP3M) formulation in an East Asian population with schizophrenia by subgroup analysis of a double-blind (DB), multicenter, noninferiority study. Of 1,429 patients who entered the open-label (OL) phase, 510 were East Asian (China: 296 [58%], Japan: 175 [34%], South Korea: 19 [4%] and Taiwan: 20 [4%]). In the 17-week OL phase, patients received paliperidone palmitate once-monthly (PP1M) formulation on day 1 (150 mg eq.), day 8 (100 mg eq.) and once-monthly thereafter (50-150 mg eq., flexible). Following the OL phase, patients (n=344 East Asian) entered DB phase and were randomized (1:1) to PP1M (n=174) or PP3M (n=170). Primary efficacy endpoint was the percentage of patients who remained relapse free at the end of the 48-week DB phase, using Kaplan-Meier cumulative survival estimate. Secondary efficacy endpoints included change from DB baseline to endpoint in Positive and Negative Syndrome Scale, Clinical Global Impression Severity, Personal and Social Performance scores and symptomatic remission. Additional assessments included caregiver burden and safety. A total of 285/344 (83%) randomized East Asian patients completed the DB phase. The percentage of patients who had a relapse event was similar on comparing PP3M (17 [10.2%]) to PP1M (20 [11.8%]), and also for Japan (PP3M: 9 [17.6%], PP1M: 13 [23.2%]) and China (PP3M: 6 [5.9%], PP1M: 7 [6.9%]). Mean change from baseline in secondary efficacy parameters was similar to the global population, regardless of treatment. Symptomatic remission was attained by 50% of the treated patients. Caregiver burden was significantly reduced (P<0.001) following treatment with PP3M/PP1M. Frequency of treatment-emergent adverse events in PP3M group during DB phase was greater in the East Asian subgroup (81%) than the global population (68%) and was higher in Japan (92%) than China (75%). Results suggest that PP3M is efficacious in the East Asian subgroup. Although treatment-emergent adverse events were slightly higher in the East Asian subgroup versus the global population, no new safety signals were identified. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 65 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 65 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 13 | 20% |
| Student > Master | 8 | 12% |
| Student > Doctoral Student | 7 | 11% |
| Other | 6 | 9% |
| Researcher | 5 | 8% |
| Other | 11 | 17% |
| Unknown | 15 | 23% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 17 | 26% |
| Nursing and Health Professions | 7 | 11% |
| Psychology | 7 | 11% |
| Social Sciences | 5 | 8% |
| Biochemistry, Genetics and Molecular Biology | 3 | 5% |
| Other | 9 | 14% |
| Unknown | 17 | 26% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 September 2017.
All research outputs
#17,292,294
of 25,382,440 outputs
Outputs from Neuropsychiatric Disease and Treatment
#1,901
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#209,586
of 327,503 outputs
Outputs of similar age from Neuropsychiatric Disease and Treatment
#45
of 80 outputs
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