Sustained, significant improvement in symptom control, HRQoL and functioning was seen in stable patients treated with RLAI over 6 months following a switch from previous antipsychotic medications.
The efficacy and tolerability of risperidone long-acting injectable were investigated in patients with schizophrenia or other psychotic disorders who had previously been symptomatically stable on olanzapine treatment. Patients received risperidone long-acting injectable, 25 mg, by intramuscular injection every 2 weeks; the dose could be increased to 37.5 or 50 mg if necessary. Patients were transferred directly from their previous medication to risperidone long-acting injectable without a run-in period of oral risperidone treatment. Of 192 patients recruited, 134 patients (70%) completed the study. The principal reasons for discontinuation were withdrawal of consent (8%), adverse events (6%), insufficient response (5%) and non-compliance (4%). Risperidone long-acting injectable produced a significant improvement (p = 0.0001) in Positive and Negative Syndrome Scale (PANSS) total scores, from 74.2+/-21.3 at baseline to 65.8+/-21.4 at endpoint. There were also significant reductions in PANSS subscales (positive symptoms, negative symptoms, general psycho-pharmacology) and Marder factor scores. The Clinical Global Impression increased significantly from baseline to endpoint (p = 0.0001), as reflected by the increase in the proportion of patients rated as 'not ill' or 'borderline ill' from 10% at baseline to 21% at endpoint. Risperidone long-acting injectable was also associated with significant improvements in Global Assessment of Function, patient satisfaction with treatment, and quality of life, measured on the SF-36 scale. Movement disorders, measured on the Extrapyramidal Symptom Rating Scale, were significantly reduced following the change to risperidone long-acting injectable. Treatment with risperidone long-acting injectable was well tolerated, and no significant weight gain occurred during the study. This open study suggests that risperidone long-acting injectable produces symptomatic improvement in schizophrenia patients previously considered symptomatically stable with olanzapine, along with improvement in movement disorders. The combination of improved efficacy and good tolerability may have important implications for patient adherence to therapy and subsequent long-term outcomes.
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.
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