P03-26 Survey of safety and efficacy of long-acting injectable risperidone in daily practice: An open-label, non-interventional prospective study - 17/03/09
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Résumé |
Objective |
This post-authorization safety survey evaluated the long-term safety, tolerability, and efficacy of risperidone long-acting injectable (RLAI) in routine clinical practice.
Methods |
In this 6-month, multicenter, European, naturalistic survey, patients were included if, during routine clinical practice, long-term antipsychotic therapy with RLAI was deemed necessary by the treating physician. Efficacy measures (at baseline and after 1, 3, 6 months) included Clinical Global Impression-Severity (CGI-S) and Global Assessment of Functioning (GAF). Safety was evaluated by recording treatment-emergent adverse events (TEAEs) at every visit.
Results |
RLAI was initiated in 5,134 predominantly male (58.6%) patients (aged 14-94 years) with a diagnosis of paranoid schizophrenia (69.8%). RLAI initial doses were 25 mg every-two-weeks in 37.0%, or 50 mg in 44.4% of patients. At endpoint, RLAI dosages were 50 mg in 49.3% of patients, 25 mg in 27.0%, and 37.5 mg in 22.1%. Six-month treatment with RLAI was completed by 4,314 patients (84.0%). RLAI was discontinued due to loss to follow-up (n=346;6.7%), insufficient response (n=116;2.3%), and AEs (n=106;2.1%). CGI-S significantly improved from baseline to endpoint (p< 0.001). Patient functioning in the GAF scale also significantly improved from baseline to endpoint (45.4±16.0 versus 62.4±17.7, respectively, p< 0.001). TEAEs were recorded by 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.
Conclusions |
This large prospective survey confirms the good safety, tolerability, and efficacy of RLAI as reported in previous controlled clinical trials when used in routine clinical practice.
Le texte complet de cet article est disponible en PDF.Vol 24 - N° S1
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