PMID- 21463526
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20110714
LR  - 20220317
IS  - 1744-859X (Electronic)
IS  - 1744-859X (Linking)
VI  - 10
DP  - 2011 Apr 4
TI  - Effectiveness of injectable risperidone long-acting therapy for schizophrenia: 
      data from the US, Spain, Australia, and Belgium.
PG  - 10
LID - 10.1186/1744-859X-10-10 [doi]
AB  - BACKGROUND: Because wide variations in mental health care utilization exist 
      throughout the world, determining long-term effectiveness of psychotropic 
      medications in a real-world setting would be beneficial to physicians and 
      patients. The purpose of this analysis was to describe the effectiveness of 
      injectable risperidone long-acting therapy (RLAT) for schizophrenia across 
      countries. METHODS: This was a pragmatic analysis of data from two prospective 
      observational studies conducted in the US (Schizophrenia Outcomes Utilization 
      Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number 
      for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic 
      Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were 
      performed to assess clinical improvement during the study and estimate 
      psychiatric hospitalization rates before and after RLAT initiation. Clinical 
      improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) 
      and Global Assessment of Functioning (GAF) scales, and change from baseline was 
      evaluated using paired t tests. Psychiatric hospitalization rates were analyzed 
      using incidence densities, and the bootstrap resampling method was used to 
      examine differences between the pre-baseline and post-baseline periods. RESULTS: 
      The initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; 
      Australia, n = 784; and Belgium, n = 408). In all, 24 months of study 
      participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), 
      and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, 
      respectively, were included in the clinical analysis. Improvements compared with 
      baseline were observed on both clinical assessments across countries (P < 0.001 
      at all post-baseline visits). The mean improvement was approximately 1 point on 
      the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 
      (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, 
      respectively, had >/=1 post-baseline visit and were included in the analysis of 
      psychiatric hospitalization rates. Hospitalization rates decreased significantly 
      in all countries regardless of hospitalization status at RLAT initiation (P < 
      0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the 
      analysis was limited to outpatients only. CONCLUSIONS: RLAT in patients with 
      schizophrenia was associated with improvements in clinical and functional 
      outcomes and decreased hospitalization rates in the US, Spain, Australia, and 
      Belgium, despite differences in health care delivery systems.
FAU - Lambert, Tim
AU  - Lambert T
AD  - University of Sydney, Sydney, Australia.
FAU - Olivares, Jose M
AU  - Olivares JM
AD  - Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
FAU - Peuskens, Joseph
AU  - Peuskens J
AD  - Universitair Psychiatrisch Centrum, KU Leuven Campus UC-St. Jozef, Kortenberg, 
      Belgium.
FAU - DeSouza, Cherilyn
AU  - DeSouza C
AD  - Veterans Affairs Medical Center, Kansas City, MO, USA.
FAU - Kozma, Chris M
AU  - Kozma CM
AD  - University of South Carolina, Columbia, SC, USA.
FAU - Otten, Patrick
AU  - Otten P
AD  - SGS Life Science Services, Mechelen, Belgium.
FAU - Crivera, Concetta
AU  - Crivera C
AD  - Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Jacobs, An
AU  - Jacobs A
AD  - Johnson & Johnson Pharmaceutical Services, Beerse, Belgium.
FAU - Macfadden, Wayne
AU  - Macfadden W
AD  - Formerly Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Mao, Lian
AU  - Mao L
AD  - Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, 
      USA.
FAU - Rodriguez, Stephen C
AU  - Rodriguez SC
AD  - Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Dirani, Riad
AU  - Dirani R
AD  - Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
FAU - Akhras, Kasem S
AU  - Akhras KS
AD  - Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00246194
PT  - Journal Article
DEP - 20110404
PL  - England
TA  - Ann Gen Psychiatry
JT  - Annals of general psychiatry
JID - 101236515
PMC - PMC3090384
EDAT- 2011/04/06 06:00
MHDA- 2011/04/06 06:01
PMCR- 2011/04/04
CRDT- 2011/04/06 06:00
PHST- 2010/10/29 00:00 [received]
PHST- 2011/04/04 00:00 [accepted]
PHST- 2011/04/06 06:00 [entrez]
PHST- 2011/04/06 06:00 [pubmed]
PHST- 2011/04/06 06:01 [medline]
PHST- 2011/04/04 00:00 [pmc-release]
AID - 1744-859X-10-10 [pii]
AID - 10.1186/1744-859X-10-10 [doi]
PST - epublish
SO  - Ann Gen Psychiatry. 2011 Apr 4;10:10. doi: 10.1186/1744-859X-10-10.