Switching to long-acting injectable risperidone: Beneficial with regard to clinical outcomes, regardless of previous conventional medication in patients with schizophrenia

Abstract

Objective:

This subanalysis of the Switch to Risperidone Microspheres (StoRMi) clinical trial, an international, 6-month, open-label investigation of long-term efficacy and safety of risperidone long-acting injectable (RLAI), focuses on a subset of non-acute schizophrenic adult patients switching from oral or depot conventional antipsychotic.

Methods:

Efficacy assessments included Positive and Negative Syndrome Scale (PANSS), Global Assessment of Functioning (GAF), quality of life, treatment satisfaction, hospitalization rates, and treatment-emergent adverse events (TEAEs).

Results:

Patients switching from oral (n=100) or depot (n=565) conventional medication were identified. Total PANSS scores decreased by 15.3 +/- 17.5 (SD) points for patients switching from oral conventional (n=96) and 9.1 +/- 19.5 points for those switching from depot conventional medication (n=550) (P=0.0001 for both). Improvements were noted for patients switching from either oral or depot agents for PANSS subscales, GAF score, quality of life, and hospitalization. Treatment was completed by >70% of patients. About 25% of patients were satisfied with their treatment at baseline compared with about 70% at endpoint after switching to RLAI. Overall RLAI was well tolerated. The most frequent TEAEs (>5%) were: anxiety (11.0%), insomnia (9.0%), weight increase (6.0%), extrapyramidal disorder (5.0%), depression (5.0%) and disease exacerbation (5.0%) for patients switching from oral conventional, and weight increase (6.0%) and disease exacerbation (5.3%) for patients switching from depot conventional medication.

Conclusion:

In this open-label study, patients with schizophrenia who were unsatisfactorily treated with oral or depot conventional antipsychotics showed improvement in symptom control, tolerability, and patient satisfaction after switching to RLAI.