Extended-release divalproex sodium for mood stabilization.
OBJECTIVE
To evaluate the efficacy, safety, and tolerability of extended-release divalproex sodium.


METHODS
Prospective, open-label, 4-week study


METHODS
Long-term care facility of the Missouri Department of Mental Health.


METHODS
Ten hospitalized patients (mean age 39.4 yrs) with mood or thought disorders who were experiencing adverse effects from delayed-release divalproex sodium.


METHODS
All participants were switched from delayed-release to extended-release divalproex sodium.


RESULTS
Efficacy was monitored with the Brief Psychiatric Rating Scale (BPRS), and safety and tolerability were monitored with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Frequently reported adverse effects before conversion were sedation, stomach upset, and tremor. At study conclusion, no differences were seen in total BPRS scores or individual BPRS items, although a trend pointed to decreased somatic complaints (p=0.057). The mean serum concentration of valproic acid among participants did not change significantly in the transition from the delayed-release formulation to an equivalent dose-adjusted extended-release formulation (90.5 mg/L vs 95.5 mg/L, p=0.493). At study conclusion, significant decreases in low-density lipoprotein cholesterol (p=0.010) and potassium (p=0.043) levels were identified. Three categories of adverse effects decreased significantly after patients switched to the extended-release form of divalproex sodium: sedation (p=0.022), stomach or abdominal discomfort (p=0.045), and tremor (p=0.004).


CONCLUSIONS
This preliminary investigation suggests that patients receiving delayed-release divalproex sodium for mood lability can be converted successfully to extended-release divalproex sodium. Moreover, these findings imply that this transition is associated with a reduction in some of the adverse effects associated with divalproex sodium.
Stoner
Steven C
SC
University of Missouri-Kansas City Schools of Pharmacy and Medicine, Kansas City, MO 64506, USA. stoners@umkc.edu
Dubisar
Beth M
BM
Lea
Jessica W
JW
Marken
Patricia A
PA
Ramlatchman
Leonard V
LV
Reynolds
James B
JB
D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale; D003692:Delayed-Action Preparations; D006801:Humans; D008134:Long-Term Care; D008875:Middle Aged; D008923:Missouri; D019964:Mood Disorders / Q000188:drug therapy*; D011446:Prospective Studies; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D018692:Antimanic Agents; D003692:Delayed-Action Preparations; D014635:Valproic Acid