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Table 5 Odds ratios by study and overall odds ratio estimated for low-dose and placebo-controlled studies

From: Suicidality and divalproex sodium: analysis of controlled studies in multiple indications

Study Population Treatment group OR (95% CI)
   DVPX, N = 1,327, n/N a Placebo, N = 992, n/N a  
Placebo-controlled studies
Willmore et al. 1996 [30] Epilepsy 1/77 0/70 2.76 (0.11 to 68.98)
Pope et al. 1991 [31] Acute mania 0/20 0/23 -
Bowden et al. 1994 [32] Acute mania 0/69 0/74 -
Bowden et al. 2000 [33] Mania maintenance 7/187 7/94 0.48 (0.16 to 1.42)
Sachs et al. 2001 [34] Bipolar depression 0/23 1/22 0.31 (0.01 to 7.89)
Hirschfeld et al. 2010 [35] Acute mania 1/146 0/78 1.62 (0.07 to 40.20)
Tariot et al. 2001 [36] Dementia 0/87 0/85 -
Bowden et al. 2006 [37] Acute mania 0/192 0/185 -
Hollander et al. 2003 [38] Impulsive aggression 2/124 1/122 1.98 (0.18 to 22.16)
Placebo-controlled studyb Dementia 0/78 0/43 -
Mathew et al. 1995 [39] Migraine 0/70 0/37 -
Klapper 1997 [40] Migraine 0/132 0/44 -
Freitag et al. 2002 [41] Migraine 0/122 0/115 -
Overall (placebo-controlled)   11/557c 9/386c 0.72 (0.29 to 1.84)
High-dose DVPX vs low-dose DVPX
   High-dose DVPX Low-dose DVPX  
Beydoun et al. 1997 [42] Epilepsy 0/131 1/134 0.34 (0.01 to 8.38)
Overall (all studies)   11/688c 10/520c 0.66 (0.27 to 1.64)
  1. aN = the number of subjects treated in the study for the prospective treatment group.
  2. bData obtained from Abbott Protocol M99-082 clinical study report (unpublished).
  3. cThe denominator presents the total number of subjects in the studies with at least one suicidality event and therefore included in the overall OR calculation.
  4. DVPX = divalproex sodium; NA = not applicable; OR = odds ratio; - = zero-event studies, OR cannot be estimated.