Effect of divalproex on metabolic parameters is dose related in migraine prophylaxis.
OBJECTIVE
To examine the metabolic effects of three divalproex dosing regimens in patients with migraine.


BACKGROUND
Epidemiological and clinical studies have demonstrated a strong association between serum lipid levels and the development of coronary artery disease. Thus, it is important to understand the impact of chronically administered medications on serum lipids. Metabolic properties of divalproex, an approved and commonly used treatment for migraine prophylaxis, have not been systematically studied in patients with migraine.


METHODS
Adult patients with migraine were randomized to receive one of three daily doses of divalproex (500 mg [n = 45], 1000 mg [n = 43], or 1500 mg [n = 44]) or placebo (n = 44) for 12 weeks. Post hoc analyses were performed to determine the effects of divalproex on total cholesterol, glucose, weight, and body mass index (BMI).


RESULTS
The treatment groups were similar at baseline based on demographic and clinical characteristics and the use of concomitant medications. Divalproex resulted in a dose-related mean decrease from baseline in total cholesterol: -5.7 mg/dL or 3% reduction with 500 mg/day; -8.4 mg/dL or 4% reduction with 1000 mg/day; and -12.8 mg/dL or 7% reduction with 1500 mg/day (P < .05 for 1500 mg/day vs. placebo). There were no differences between any divalproex dose group and placebo for mean change from baseline in glucose, weight, or BMI.


CONCLUSIONS
Divalproex results in a dose-dependent reduction in serum cholesterol within the first 3 months of therapy, with no significant change in serum glucose or BMI.
Green
Mark W
MW
Department of Neurology, Columbia University College of Physicians and Surgeons, New York, NY 10022, USA.
Giordano
Suzanne
S
Jiang
Ping
P
Jafari
Mahtab
M
Smith
Thomas B
TB
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005260:Female; D018682:GABA Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000097:blood / Q000517:prevention & control*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage / Q000627:therapeutic use*
D001786:Blood Glucose; D018682:GABA Agents; D014635:Valproic Acid; D002784:Cholesterol