MOUNTAIN VIEW, Calif., July 20, 2011 /PRNewswire/ — VIVUS, Inc.
(NASDAQ:
VVUS) today announced that on August 31, 2011, during the late
breaking poster session at the 29th International Epilepsy Congress
(IEC) in Rome, Italy, Dr. Alison Pack, Associate Professor of
Clinical Neurology, Department of Neurology, Columbia University
Medical Center, will present the results of a retrospective study
of medical claims data on oral clefts (OC) and major congenital
malformations (MCMs) associated with in utero topiramate
exposure. The IEC is one of the largest international gatherings of
medical professionals focused on the management of patients with
epilepsy.
The study was conducted using medical claims and pharmacy
prescription data from the Wolters Kluwer Pharma Solutions
Source® Lx Patient Longitudinal Database, which identified 778
mother-infant dyads exposed to topiramate within 10 months prior to
giving birth. The study also included two
non-topiramate-exposed control groups: one comprised of 3,431 dyads
exposed to other antiepileptic drugs (AEDs) during pregnancy and a
second of 2,307 dyads with a diagnosis of epilepsy, but no exposure
to topiramate during pregnancy. In all cohorts, known or suspected
teratogens, including valproate, and phenytoin were excluded. The
risk of OC and MCM due to topiramate exposure was calculated in
comparison to the other AED exposed and the non-topiramate exposed
Epilepsy groups. The results are as follows: Topiramate
Group
AED Group
Epilepsy GroupFrequency of:Oral cleft
0.26%
0.20%
0.30%Major malformations
4.11%
3.50%
4.72%The relative risk (95% CI) for the topiramate group vs.
other AEDs group for OCs was 1.26 (0.26-6.05) and the relative risk
of MCMs was 1.18 (0.80-1.72). For the topiramate vs. the
non-topiramate exposed Epilepsy group, the relative risk
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