PMID- 26150722
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150707
LR  - 20201001
IS  - 1176-6328 (Print)
IS  - 1178-2021 (Electronic)
IS  - 1176-6328 (Linking)
VI  - 11
DP  - 2015
TI  - The social functional outcome of being naturalistically treated with paliperidone 
      extended-release in patients with schizophrenia.
PG  - 1511-21
LID - 10.2147/NDT.S85891 [doi]
AB  - BACKGROUND: Social functioning is an important outcome for patients with 
      schizophrenia. To evaluate the effects of paliperidone extended-release (PAL-ER) 
      on social function, symptomatology, and safety in the routine clinical practice, 
      we conducted a 1-year post-marketing surveillance study of PAL-ER. We also 
      explored relationships between symptomatic improvement and socially functional 
      outcome in patients with schizophrenia. PATIENTS AND METHODS: Patients with an 
      established diagnosis of schizophrenia were allowed flexible 3-12 mg/day dosing 
      during the surveillance. Patients were assessed on social functioning using the 
      Social and Occupational Functioning Assessment Scale (SOFAS) and on 
      symptomatology using the Clinical Global Impression-Schizophrenia scale. All 
      adverse events (AEs) were also collected. RESULTS: A total of 1,429 patients were 
      enrolled in the surveillance study, of whom 1,405 were evaluable for safety and 
      1,142 were evaluable for efficacy. The treatment discontinuation rate for any 
      reason during the observation period was 34.66%. Significant improvements were 
      observed on both Social and Occupational Functioning Assessment Scale and 
      Clinical Global Impression-Schizophrenia scale during the observation period. The 
      percentage of patients with socially functional remission (SOFAS >/=61) also 
      increased significantly. A significant association between early improvements in 
      positive symptoms, sex, severity of negative symptoms at baseline, and socially 
      functional remission was observed. A total of 33.52% of patients had AEs and 
      8.75% of patients had serious AEs. Despite the recommendation of monotherapy with 
      PAL-ER, 65.84% of patients were given additional antipsychotics (polypharmacy). 
      Post hoc comparisons of monotherapy versus polypharmacy revealed that the 
      monotherapy group had better outcomes and fewer AEs than the polypharmacy treated 
      group. The improvement in social functioning and the rate of socially functional 
      remission did not differ between groups. CONCLUSION: PAL-ER treatment showed 
      effective symptom control and improvement in social functioning. The data suggest 
      that early response to antipsychotic treatment should be important for functional 
      outcomes.
FAU - Nakagawa, Ryoko
AU  - Nakagawa R
AD  - Evidence Generation Department, Medical Affairs Division, Janssen Pharmaceutical 
      K.K., Tokyo, Japan.
FAU - Ohnishi, Takashi
AU  - Ohnishi T
AD  - Evidence Generation Department, Medical Affairs Division, Janssen Pharmaceutical 
      K.K., Tokyo, Japan.
FAU - Kobayashi, Hisanori
AU  - Kobayashi H
AD  - Evidence Generation Department, Medical Affairs Division, Janssen Pharmaceutical 
      K.K., Tokyo, Japan.
FAU - Wakamatsu, Akihide
AU  - Wakamatsu A
AD  - Medical Affairs Strategy Department, Medical Affairs Division, Janssen 
      Pharmaceutical K.K., Tokyo, Japan.
FAU - Tanimura, Ai
AU  - Tanimura A
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Morita, Kazuo
AU  - Morita K
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Yamaoka, Toshio
AU  - Yamaoka T
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Usui, Hideo
AU  - Usui H
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Ogawa, Yoshimasa
AU  - Ogawa Y
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Fujino, Akiko
AU  - Fujino A
AD  - Drug Safety Surveillance Department, Japan Safety and Surveillance Division, 
      Janssen Pharmaceutical K.K., Tokyo, Japan.
FAU - Yoshizawa, Kazutake
AU  - Yoshizawa K
AD  - Evidence Generation Department, Medical Affairs Division, Janssen Pharmaceutical 
      K.K., Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20150622
PL  - New Zealand
TA  - Neuropsychiatr Dis Treat
JT  - Neuropsychiatric disease and treatment
JID - 101240304
PMC - PMC4484658
OTO - NOTNLM
OT  - naturalistic study
OT  - paliperidone
OT  - schizophrenia
OT  - social function
EDAT- 2015/07/08 06:00
MHDA- 2015/07/08 06:01
PMCR- 2015/06/22
CRDT- 2015/07/08 06:00
PHST- 2015/07/08 06:00 [entrez]
PHST- 2015/07/08 06:00 [pubmed]
PHST- 2015/07/08 06:01 [medline]
PHST- 2015/06/22 00:00 [pmc-release]
AID - ndt-11-1511 [pii]
AID - 10.2147/NDT.S85891 [doi]
PST - epublish
SO  - Neuropsychiatr Dis Treat. 2015 Jun 22;11:1511-21. doi: 10.2147/NDT.S85891. 
      eCollection 2015.