Faculty Collaboration Database

Time course of adverse events most commonly associated with topiramate for migraine prevention. Eur J Neurol 2007 Aug;14(8):900-6

Date

07/31/2007

Pubmed ID

17662012

DOI

10.1111/j.1468-1331.2007.01869.x

Scopus ID

2-s2.0-34547132775 (requires institutional sign-in at Scopus site)   50 Citations

Abstract

The efficacy, safety and tolerability of topiramate has been demonstrated in three large multicenter, randomized, double-blind, placebo-controlled trials. To characterize the time course of adverse events (AEs) that led to treatment discontinuation in >/=2% of patients who received topiramate 100 mg/day during three pivotal, multicenter, randomized, double-blind, placebo-controlled, and 26-week trials. The pooled population comprised all randomized patients who reported safety data during the double-blind phase (topiramate 100 mg/day, n = 386; placebo n = 372), which consisted of a 4-week titration period and a 22-week maintenance period. Incidence, time to onset, and cumulative mean rate of AEs were assessed. Overall, AEs led to treatment discontinuation in 24.9% of patients receiving topiramate 100 mg/day and 11.0% receiving placebo (P < 0.001). AEs leading to discontinuation during the double-blind phase in > or =2% of patients included paresthesia (8.0% discontinued), any cognitive symptoms (7.3% discontinued), fatigue (4.7% discontinued), insomnia (3.4% discontinued), nausea (2.3% discontinued), loss of appetite, anxiety, and dizziness (2.1% discontinued because each AE). Most AEs began during the titration period. Paresthesia, any cognitive symptoms, nausea, and loss of appetite occurred at a higher rate in the topiramate group than in the placebo group (P < 0.01). AEs leading to discontinuation of topiramate are probably to occur during dose titration. If a patient has not experienced one of these AEs within the first 6 weeks of initiating topiramate 100 mg/day, these AEs are unlikely to occur.

Author List

Láinez MJ, Freitag FG, Pfeil J, Ascher S, Olson WH, Schwalen S

MESH terms used to index this publication - Major topics in bold

Adult
Anorexia
Anticonvulsants
Cognition Disorders
Dose-Response Relationship, Drug
Double-Blind Method
Fatigue
Female
Fructose
Humans
Male
Middle Aged
Migraine Disorders
Nausea
Paresthesia
Patient Compliance
Placebos
Time
Time Factors
Withholding Treatment