Ziprasidone의 안전성과 유효성에 관한 국내 시판 후 조사 연구 = The Safety and Efficacy of Ziprasidone: Post-Marketing Surveillance Study in Korea

다국어 초록 (Multilingual Abstract)

Objective The aim of this study was to observe the safety and efficacy of ziprasidone in the usual care setting in patients with schizophrenia or acute manic or mixed episodes associated with bipolar disorder.
Methods A total of 3,391 patients who were treated with ziprasidone were enrolled from 108 centers in Korea. Differences in the clinical global impression of severity and clinical global impression of improvement (CGI-I) were measured after 8±1 weeks administration of ziprasidone. Adverse events were observed in all subjects who were administered ziprasidone at least once. In 330 patients, the change of weight was evaluated.
Results Ziprasidone was effective for most of schizophrenia and acute manic or mixed episodes associated with bipolar disorder patients. CGI-I score was improved in 84.8% of PP subjects. Of the subjects who did not complete the study, sixty-four (1.9%) subjects discontinued treatment due to adverse events. The most common adverse events were akathisia, somnolence,extrapyramidal symptoms and insomnia. In total, 6 serious adverse events were reported in 2 subjects, including psychotic disorder and suicidal attempt. Mean 0.9 kg of weight loss was observed.
Conclusion ziprasidone was effective, safe and generally well tolerated for schizophrenia or acute manic or mixed episodes associated with bipolar disorder patients in Korea.

국문 초록 (Abstract)

본 연구는 3,391명의 환자에서 ziprasidone의 시판 후 조사를 통해 실제 임상 상황에서의 정신분열병, 양극성 장애와 관련된 급성 조증 혹은 혼재 삽화 치료에 대한 유효성과 안전성을 관찰하였다. 한 번 이상 연구 약물을 복용한 모든 환자에서 82.2%의 임상적 호전이 관찰되었다. 평균 75.8일의 복용기간 동안 평균 0.9 kg의 유의한 체중 감소가 나타났으며, 이 외 가장 흔한 유해사례는 정좌불능, 졸림, 추체외로 증상과 불면증이었다. 중대한 유해사례는 2명의 환자에서 발생하였는데, 그 중 1명에서 정신증적 증상과 자살 시도가 있었다.
결론적으로 국내에서 ziprasidone은 실제의 일반적인 임상 상황에서 정신분열병, 양극성 장애와 관련된 급성 조증 혹은 혼재 삽화 치료에 안전하고 효과적으로 사용될 수 있다고 판단된다.

참고문헌 (Reference)

1 안용민, "정신분열병 환자에서 12주간 지프라시돈과 리스페리돈 투여에 의한 체중 증가 및 대사성 부작용 비교" 대한정신약물학회 18 (18): 92-102, 2007

2 최남경, "우리나라 약물유해반응 감시체계" 대한예방의학회 40 (40): 278-284, 2007

3 이승재, "Ziprasidone의 자연적 임상경험에 대한 후향적 조사 연구 : 3개 대학병원의 경험" 대한신경정신의학회 46 (46): 214-222, 2007

4 Harvey PD, "Ziprasidone: efficacy, tolerability, and em-erging data on wide-ranging effectiveness" 6 : 337-346, 2005

5 Daniel DG, "Ziprasidone: comprehensive overview and clinical use of a novel antipsychotic" 9 : 819-828, 2000

6 Warrington L, "Ziprasidone for the tr-eatment of acute manic or mixed episodes associated with bipolar disorder" 21 : 835-849, 2007

7 Greenberg WM, "Ziprasidone for schizophrenia and bipolar disorder: a review of the clinical trials" 13 : 137-177, 2007

8 Kelly DL, "Ziprasidone and the QTc interval: pharmacokinetic and pharmacodynamic considerations" 35 : 66-79, 2001

9 Rosa AR, "Zi-prasidone in the treatment of affective disorders: a review" 14 : 278-286, 2008

10 Wetterling T, "Weight gain: side effect of atypical neuroleptics" 19 : 316-321, 1999

11 Hummer M, "Weight gain induced by clozapine" 5 : 437-440, 1995

12 Heinrich TW, "Torsades de pointes associated with ziprasidone" 47 : 264-268, 2006

13 Daniel DG, "Tolerability of ziprasidone: an expanding perspective" 64 (64): 40-49, 2003

14 Edwards SJ, "Tolerability of atypical antipsychotics in the treatment of adults with schizophrenia or bipolar disorder: a mixed tr-eatment comparison of randomized controlled trials" 31 (31): 1345-1359, 2009

15 Leucht S, "Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis" 373 : 31-41, 2009

16 Kane JM, "Oral ziprasidone in the treatment of schizophrenia: a review of short-term trials" 64 (64): 19-25, 2003

17 Newcomer JW, "Metabolic considerations in the use of antipsychotic medications: a review of recent evidence" 68 (68): 20-27, 2007

18 Correll CU, "From receptor pharmacology to improved outcomes: individualising the selection, dosing, and switching of antipsychotics" 25 (25): S12-S21, 2010

19 Nemeroff CB, "From clinical research to clinical practice: a 4-year review of ziprasidone" 10 (10): 1-20, 2005

20 Kane JM, "Efficacy and tolerability of ziprasidone in patients with treatment-resistant schizophrenia" 21 : 21-28, 2006

21 Kudla D, "Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial" 22 : 195-202, 2007

22 McEvoy JP, "Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment" 163 : 600-610, 2006

23 Brown RR, "Comparison of the metabolic effects observed in patients treated with ziprasidone versus olanzapine" 20 : 105-112, 2005

24 Strom BL, "Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)" 168 : 193-201, 2011