CHOLESTEROL LOWERING EFFECTS OF DIVALPROEX SODIUM IN ADULT PATIENTS WITH COMPLEX PARTIAL SEIZURES
Abstract number :
3.129
Submission category :
Year :
2002
Submission ID :
3218
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Mahtab Jafari, L. James Willmore, Patricia Wozniak, Suzanne Giordano, Kenneth Sommerville. Neuroscience, Abbott Laboratories, Abbott Park, IL; Neurology, Saint Louis University, Saint Louis, MO
RATIONALE: Epidemiological and clinical studies have demonstrated that serum lipids are closely related to the development of coronary artery disease (CAD) and every 1% increase in total cholesterol results in 2% increase in the risk of developing CAD. A number of studies have reported the evidence that long-term antiepileptic drug (AED) therapy influences total cholesterol. The effect of Divalproex sodium (DVPX) on cholesterol has not been systematically studied in epilepsy.
At the end of this activity the participants should be able to discuss the effect of DVPX on total cholesterol in patients with complex partial seizures.
METHODS: A retrospective analysis of a randomized, double-blind, placebo-controlled, and add-on trial of DVPX in adult patients with complex partial seizures was conducted. Other AEDs were protocol-allowed. A variety of metabolic parameters were analyzed.
RESULTS: Data from all 147 subjects who received randomized study drug were included in this analysis, 77 of those subjects were treated with DVPX and 70 subjects were treated with placebo (PBO). The mean concentration of DVPX was 62.8 (+/-22.81) during the experimental phase of 16 weeks. Mean serum cholesterol levels decreased by 14.1 mg/dL in the DVPX group and increased by 1.5 mg/dL in the PBO group (p=0.002). Changes from baseline to final evaluation in total protein, SGOT, and SGPT were not significantly different between the two treatment groups. Mean albumin levels decreased by 0.15 (+/-0.292) in DVPX group and by 0.03 (+/-0.298) in PBO group (p=0.015). Mean glucose levels decreased by 3.9 mg/dL in DVPX group and decreased by 8.9 mg/dL in PBO group (p=0.287). Mean weight increased by 0.7 (+/- 5.1) Kg in the DVPX group and by 1.4 (+/- 3.8) Kg in the PBO group (p= 0.281).
CONCLUSIONS: Compared to PBO, total cholesterol reduction by DVPX was statistically significant. The 7% decrease in total cholesterol by DVPX may potentially result in less risk of developing CAD. Cholesterol lowering effects of DVPX has also been reported from preliminary data in patients with bipolar disorder.
[Supported by: This Study was funded by Abbott Laboratories.]; (Disclosure: Salary - Abbott Laboratories, Grant - Abbott Laboratories, Stock - Abbott Laboratories, Honoraria - Abbott Laboratories)