American Statistical Association
The US Food and Drug Administration (FDA) issued separate warnings for suicidality with antidepressants and antiepileptic drugs in the past five years. This study describes methods for examining the association of these agents with suicide attempts and suicide deaths in more broadly generalizable samples than examined by the FDA. An observational study of mood disorders was examined that includes three decades of prospective assessments. Due to sample size differences, two distinct longitudinal implementations of the propensity adjustment are used in separate analyses of antidepressants and antiepileptic drugs. Propensity score quintile-stratified safety analyses were used with the large antidepressant data set; whereas, propensity score matched safety analyses were used with the smaller antiepileptic drug data because stratification was not feasible. In each case, mixed-effects survival models compared safety of participants when receiving the respective class of medication to periods when they did not receive that medication. When participants were more severely ill, they were significantly more likely to receive either class of psychotropics. Propensity quintile-stratified safety analyses found that risk of suicide attempts or suicides was significantly reduced when participants received antidepressants. In contrast, propensity score matched safety analyses found neither significant risk nor protection from suicidality among participants receiving antiepileptics.
Andrew C. Leon, Ph.D. is Professor of Biostatistics in Psychiatry and Professor of Public Health at Weill Cornell Medical College. He is the Director of the Methods Core for the Weill Cornell Advanced Center for Interventions and Services Research in Late Life Depression. His NIH-funded grant, "Dynamic Techniques for Treatment Effectiveness Analyses" (R01 MH0640447), was initially awarded in 2001. He also collaborates in clinical trials and epidemiologic studies. Current projects include: 1) A mixed-effect propensity adjustment for evaluating treatment effectiveness in longitudinal, observational studies, 2) Reducing attrition bias in randomized controlled clinical trials, and 3) Multiplicity Adjustment Strategies for Correlated Binary Endpoints.
|Date:||Tuesday, January 24, 2012|
|Time:||3:30 - 4:30 P.M.|
New York State Psychiatric Institute
1051 Riverside Drive
6th Floor Multipurpose Room (6602)
New York, New York