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Safety and efficacy of long-acting injectable risperidone in daily practice: an open-label, noninterventional, prospective study in schizophrenia and related disorders

Parellada, Eduarda; Kouniakis, Filipposb; Siurkute, Aldonac; Schreiner, Andreasd; Don, Lianae

International Clinical Psychopharmacology: May 2010 - Volume 25 - Issue 3 - p 149-154
doi: 10.1097/YIC.0b013e328336c93f
Original Articles

This postauthorization safety study evaluated the long-term safety, tolerability, and efficacy of risperidone long-acting injectable (RLAI) in routine clinical practice. In this 6-month, multicenter, European, naturalistic study, patients were included if, during routine clinical practice, long-term antipsychotic therapy with RLAI was deemed necessary by the treating physician. Efficacy measures included Clinical Global Impression-Severity and Global Assessment of Functioning. Safety was evaluated by recording treatment-emergent adverse events (AE). RLAI was initiated in 5134 patients (aged 14–94 years); predominantly male (58.6%) with paranoid schizophrenia (69.8%). RLAI initial doses were 25 mg every 2 weeks (37.0% patients), 37.5 mg (18.0%), and 50 mg (44.4%). Treatment was completed by 4314 patients (84.0%). RLAI was discontinued on account of loss to follow-up (n=346; 6.7%), insufficient response (n=116; 2.3%), and AEs (n=106; 2.1%). Clinical Global Impression-Severity significantly improved from baseline to endpoint (P<0.001). Patient functioning on the Global Assessment of Functioning scale also significantly improved from baseline to endpoint (45.4±16.0 vs. 62.4±17.7, respectively, P<0.001). Treatment-emergent AEs were recorded by 1018 (20%) of patients. AEs occurring in ≥5% of patients were akathisia, extrapyramidal disorders, depression, psychotic disorder, anxiety, and weight gain. Serious AEs were reported by 384 (8%) patients. This study confirms good safety, tolerability, and efficacy with RLAI in routine clinical practice.

aClinic Schizophrenia Program, Hospital Clínic de Barcelona, University of Barcelona, CIBERSAM, Spain

bSecond Department of Psychiatry, Aristotle University of Thessaloniki, Thessaloniki, Greece

cRepublican Vilnius Psychiatric Hospital, Vilnius, Lithuania

dJanssen-Cilag, Medical Affairs EMEA, Neuss, Germany

eSpitalul Judetean Clinica de Psihiatrie, Cluj-Napoca, Romania

Correspondence to Dr Eduard Parellada, Psychiatry Department, Stairs 9, 6th Floor, Clinic Schizophrenia Program, Hospital Clínic, Villarroel 170, 08036 Barcelona, Spain

Tel: +34 93 227 55 47; fax: +34 93 227 55 48; e-mail:

Received 10 June 2009 Accepted 18 December 2009

© 2010 Lippincott Williams & Wilkins, Inc.