리스페리돈 장기 지속형 주사제의 효용과 안정성 : 12주 다기관 경구 항정신병약물로부터 교체연구

Abstract

Objective：To evaluate maintained effectiveness and tolerability when treated with long-acting risperidone compared to the previous antipsychotics in patients with schizophrenia or other psychotic disorders and to compare maintained effectiveness between oral risperidone and non-risperidone subgroups.

Methods：Subjects aged at least 18 years who required long-term antipsychotic therapy and who have been symptomatically stable on a stable dose of antipsychotics during the last month were enrolled in the non-randomized, single-arm, multi-center, 12 weeks duration study. Antipsychotic medications were switched from oral antipsychotics to long-acting risperidone. Injections were administered every 2 weeks. Most patients were started on 25mg long-acting risperidone injection or 37.5mg in some patients. The dosage were adjusted according to the patients' symptoms and responses to treatment at the discretion of investigators. Oral antipsychotics were continued at the same dose as before for 2 weeks and then were stopped or tapered off within next 7days.

Results：A total of 204 patients with schizophernia (N=192) and other psychotic disorder (N=12) from 20 sites in Korea were enrolled. The drop-out rate was 22.5% at 12 weeks. LOCF analysis has been performed. At 12 weeks after switching from oral antipsychotics to long-acting risperidone, statistically significant improvement was observed from baseline across all symptom domains including PANSS total, positive, negative, general subscale, CGI-S(Clinical Global Impression-Severity) scores and GAF(Global Assessment of Functioning) scores. The proportion of responders was 36.8% where response was defined as ≥20% reduction from baseline PANSS total score. The proportion of symptom worsening at 12 weeks was 7.4%(N=15) where symptom worsening was defined as ≥20% increase from baseline in PANSS total score or drop-out due to insufficient response or any 2 points change on any of 4 PANSS psychotic items(delusion, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution) excluding changes in which the ratings remained at nonpsychotic levels (i.e ＞3). Significant improvement from baseline was also observed in the measure of parkinsonism assessed using Extrapyramidal Symptom Rating Scale (ESRS). In addition, overall, patients were satisfied with long-acting risperidone injection on a single item measure of satisfaction. When subgroup analysis was performed on the basis of previous antipsychotics before switching to long-acting risperidone, no statistically significant differences were detected between oral risperidone(N=139) and non-risperidone subgroup(N=65) on all measures of effectiveness and tolerability including baseline demographic and clinical characteristics, symptom improvements, proportion of symptom improvement or worsening and ESRS score changes.

Conclusion：Our study results demonstrated maintained effectiveness and tolerability of long-acting risperidone microsphere and also could confirm successful switching from not only oral risperidone but also non-risperidone to long-acting risperidone injection.