Depakote ER: Pivotal Study Lab. Values
DEPAKOTE ER Change in Laboratory Values at Day 215,22
Mean Change From Baseline to Final Value
- Hepatic failure resulting in fatalities has occurred in patients taking valproic acid and its derivatives.
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Observations of Select Laboratory Values at Day 2122
- Depakote ER was associated with a moderate increase in weight gain compared to placebo (1.8 kg vs 0.5 kg), P < 0.001
- There were no statistically significant differences between the treatment groups for mean change from baseline to final values in blood pressure, heart rate, and temperature5
- The frequency of adverse events (particularly elevated liver enzymes and thrombocytopenia) may be dose related (Please see Important Safety Information on Indication/Safety tab)1,2
- In adults, the normal platelet count range is 150-450 (x109/L)7
STUDY DESIGN:
Laboratory data were evaluated across the study population using a one-way ANOVA with treatment as the main effect. The primary analysis was on the change from baseline to final value during the study for each variable. Cholesterol and fasting glucose were measured on days 5 and 21.
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