suicidality and divalproex sodium analysis of controlled studies in multiple indications自杀倾向和双丙戊酸钠的分析控制研究多个迹象.pdfVIP

Redden et al. Annals of General Psychiatry 2011, 10:1 /content/10/1/1 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 (0.83%) subjects taking divalproex sodium, 11 had suicidality events: 2 suicide attempts and 9 suicidal ideation. Of 992 (0.91%) 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 0.72 (95% CI 0.29 to 1.84). The OR for suicidal behavior was 0.37 (95% CI 0.04 to 2.58), and the OR for suicidal ideation was 0.90 (95% CI 0.31 to 2.79). Conclusions: I