Survey of Safety and Efficacy of Long-acting Injectable Risperidone in Daily Practice: An Open-label, Non-interventional Prospective Study

Abstract

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.