Table 5

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

Study

Population

Treatment group

OR (95% CI)


DVPX, N = 1,327, n/Na

Placebo, N = 992, n/Na


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)


aN = the number of subjects treated in the study for the prospective treatment group.

bData obtained from Abbott Protocol M99-082 clinical study report (unpublished).

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.

DVPX = divalproex sodium; NA = not applicable; OR = odds ratio; - = zero-event studies, OR cannot be estimated.

Redden et al. Annals of General Psychiatry 2011 10:1   doi:10.1186/1744-859X-10-1

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