Báo cáo y học: "Suicidality and divalproex sodium: analysis of controlled studies in multiple indications"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Suicidality and divalproex sodium: analysis of controlled studies in multiple indications. | Redden et al. Annals of General Psychiatry 2011 10 1 http content 10 1 1 ANNALS OF GENERAL PSYCHIATRY PRIMARY RESEARCH Open Access Suicidality and divalproex sodium analysis of controlled studies in multiple indications Laura Redden Yili Pritchett Weining Robieson Xenia Kovacs Mary Garofalo Katherine Tracy Mario Saltarelli Abstract Background Recent analyses of antiepileptic drugs have indicated an increase in the risk of suicidality. The objective of this report was to provide clinical information and an independent meta-analysis of divalproex sodium and suicidality events by analyzing data from 13 placebo-controlled studies and 1 low-dose controlled study. Methods Adverse events considered to be possibly suicide related were identified using the Columbia Classification Algorithm of Suicide Assessment C-CASA methodology. Indications included epilepsy bipolar disorder migraine prophylaxis impulsive aggression and dementia. Narratives were produced for every event and suicidality event ratings were performed by a third party blinded to treatment assignment. Statistical analyses were conducted using methodology similar to that reported by the US Food and Drug Administration FDA . Results Suicidality events were identified in 5 of the 13 placebo-controlled studies. Of the 1 327 subjects taking divalproex sodium 11 had suicidality events 2 suicide attempts and 9 suicidal ideation. Of 992 subjects taking placebo 9 had suicidality events 1 preparatory act toward suicide 2 suicide attempts and 6 suicidal ideation. Across placebo-controlled studies the overall estimated odds ratio OR of suicidal behavior or ideation was 95 CI to . The OR for suicidal behavior was 95 CI to and the OR for suicidal ideation was 95 CI to . Conclusions In this meta-analysis divalproex sodium does not appear to increase the risk of suicide-related adverse events relative to placebo in the populations .

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