정신분열병 환자에서 푸마르산 쿠에티아핀 서방정 교체 후의 임상적 이득과 주관적 안녕감 변화: 비중재, 관찰 연구 (CLIMAX Study) = Changes of Clinical Benefit and Subjective Wellbeing after Switching to Extended Release Quetiapine Furmate (Quetiapine XR) in Patients with Schizophrenia: Naturalistic, Observational Study (CLIMAX Study)

다국어 초록 (Multilingual Abstract)

Objective The aim of this study was to demonstrate changes of clinical benefit and subjective wellbeing after once-daily extended release quetiapine furmate (quetiapine XR) in patients with schizophrenia.
Methods In a naturalistic, observational, and multicentric study, 1,494 patients with schizophrenia who switched to quetiapine XR (flexible dosing) due to insufficient efficacy or intolerance were recruited. Clinical Global Impressions-Clinical Benefit (CGI-CB), CGI-Severity (CGI-S), CGI-Improvement (CGI-I) and Subjective Wellbeing under Neuroleptic Treatment Scale (SWN-K) were assessed at baseline and after 8 weeks treatment. We also examined factors related to changes of CGI-CB and SWN-K scores using linear regression analysis.
Results Among 1,494 patients, 1,342 patients (89.8%) completed this study and 1,204 patients (80.6%) without protocol violation were included in the analysis. The mean dose of quetiapine XR was 416.9±205.8 mg/day at the initiation and continuously increased to 591.6±228.3 mg/day until week 5. At the endpoint, the mean dose of quetiapine XR was 580.24±382.24 mg/day. Both CGI-CB and CGI-S scores were significantly decreased after 8 weeks (both p<0.0001) and 745 patients (61.9%) achieved clinical benefit. Mean CGI-I scores were 2.49±0.80 and the response rate defined as CGI-I≤2 was 51.6%. Subjective wellbeing scores were increased after 8weeks (p<0.0001). Improvements of CGI-CB and subjective wellbeing were associated with quetiapine XR dosages as well as age and baseline scores.
Conclusion After switching to quetiapine XR, 61.9% of patients with schizophrenia who had a history of unsatisfactory treatment (efficacy or tolerance) showed clinical benefit and subjective wellbeing was significantly increased. Regarding that dosages of quetiapine XR were associated with improvements of clinical benefit and subjective wellbeing, active treatment strategies with higher dosages of quetiapine XR could be suggested in the real field.

국문 초록 (Abstract)

본 연구는 기존의 항정신병 약물에서 quetiapine XR로 교체한 정신분열병 환자를 8주간 전향적으로 조사하여 임상적 이득과 주관적 안녕감의 변화를 평가한 개방형 다기관 공동 연구이다. 총 1,494명의 환자를 모집하였으며 이중 8주 연구과정을 완료하고 포함기준에 부합하고 연구계획을 위반하지 않은 1,204명의 환자를 분석한 결과, quetiapine XR 교체 후 임상적 이득과 주관적 안녕감이 유의하게 향상되는 것을 알 수 있었다. quetiapine XR을 고용량으로 시작할수록 이러한 개선 효과가 뚜렷하게 나타났는데 하루 한 번 복용뿐 아니라 증량이 손쉽도록 개발된 제형인 만큼 치료 시작 단계부터 적극적인 용량 적용이 추천된다.

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