PMID- 15857429
OWN - NLM
STAT- MEDLINE
DCOM- 20050601
LR  - 20181201
IS  - 0013-9580 (Print)
IS  - 0013-9580 (Linking)
VI  - 46
IP  - 5
DP  - 2005 May
TI  - Time course of adverse events in patients with localization-related epilepsy 
      receiving topiramate added to carbamazepine.
PG  - 648-53
AB  - PURPOSE: To explore the time course of treatment-emergent adverse events (AEs) 
      during topiramate (TPM) adjunctive therapy. METHODS: Post hoc analyses were 
      performed by using data from a large (264 subjects) multicenter, double-blind, 
      placebo-controlled trial in which 200 mg/day TPM was added to carbamazepine (CBZ) 
      with or without another antiepileptic drug (AED) in adults with 
      treatment-resistant partial-onset seizures. The daily incidence and mean duration 
      of the most common (> or =5% incidence) AEs were calculated for patients 
      completing the 12-week study. RESULTS: The daily incidence of somnolence, 
      headache, loss of appetite, nervousness, fatigue, dizziness, upper respiratory 
      tract infection, and vertigo peaked during titration and declined to rates 
      similar to that of placebo after the target TPM dose had been reached. In 
      contrast, the daily incidence of paresthesia increased during titration and was 
      maintained for the study duration. Relatively few patients had cognitive symptoms 
      (9% with TPM, 5% with placebo), but these were the most common AEs associated 
      with treatment discontinuation. Patient/investigator reports of weight loss 
      increased gradually over the course of the trial, corresponding with the pattern 
      of change in weight measured at study visits. CONCLUSIONS: This study 
      demonstrates that most of the more common AEs with TPM adjunctive therapy are 
      transient. Patients can be counseled that most AEs emerging when TPM is initially 
      added to CBZ can be expected to diminish with continued therapy.
FAU - Majkowski, Jerzy
AU  - Majkowski J
AD  - Foundation of Epileptology, Warsaw, Poland.
FAU - Neto, Walter
AU  - Neto W
FAU - Wapenaar, Robert
AU  - Wapenaar R
FAU - Van Oene, Joop
AU  - Van Oene J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Placebos)
RN  - 0H73WJJ391 (Topiramate)
RN  - 30237-26-4 (Fructose)
RN  - 33CM23913M (Carbamazepine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/*adverse effects/*therapeutic use
MH  - Anxiety/chemically induced/epidemiology
MH  - Carbamazepine/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/*drug therapy
MH  - Feeding and Eating Disorders/chemically induced/epidemiology
MH  - Female
MH  - Fructose/*adverse effects/*analogs & derivatives/therapeutic use
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Meta-Analysis as Topic
MH  - Middle Aged
MH  - Paresthesia/chemically induced/epidemiology
MH  - Placebos
MH  - Randomized Controlled Trials as Topic/statistics & numerical data
MH  - Sleep Wake Disorders/chemically induced/epidemiology
MH  - Time Factors
MH  - Topiramate
MH  - Weight Loss/drug effects
EDAT- 2005/04/29 09:00
MHDA- 2005/06/02 09:00
CRDT- 2005/04/29 09:00
PHST- 2005/04/29 09:00 [pubmed]
PHST- 2005/06/02 09:00 [medline]
PHST- 2005/04/29 09:00 [entrez]
AID - EPI35904 [pii]
AID - 10.1111/j.1528-1167.2005.35904.x [doi]
PST - ppublish
SO  - Epilepsia. 2005 May;46(5):648-53. doi: 10.1111/j.1528-1167.2005.35904.x.