Document Detail


Tiagabine: the safety landscape.
MedLine Citation:
PMID:  8595787     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Tiagabine (TGB) hydrochloride is a potential new antiepileptic drug (AED) undergoing clinical development. Experience in humans amounts to 1,810 patient-years of exposure. TGB was found to be tolerated in an integrated safety analysis of five double-blind, add-on therapy trials involving approximately 1,000 patients with epilepsy with difficult-to-control seizures with existing AEDs. Discontinuation resulting from adverse events were infrequent, occurring in 15% of patients receiving TGB compared to 5% receiving placebo. The most frequently reported adverse event was dizziness, which was usually transient and did not require medical intervention. Adverse events that were statistically significantly more common with TGB than placebo were dizziness, asthenia, nervousness, tremor, diarrhea, and depression (not major depression). Adverse events were usually mild to moderate in severity and transient, and most were associated with dose titration. The incidence, type, and severity of adverse events in long-term studies were comparable with those in short-term studies. Serious adverse events were uncommon and no idiosyncratic events were reported.
Authors:
I E Leppik
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Epilepsia     Volume:  36 Suppl 6     ISSN:  0013-9580     ISO Abbreviation:  Epilepsia     Publication Date:  1995  
Date Detail:
Created Date:  1996-04-17     Completed Date:  1996-04-17     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2983306R     Medline TA:  Epilepsia     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  S10-S13     Citation Subset:  IM    
Affiliation:
Department of Neurology, University of Minnesota, Minneapolis, USA.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Aged
Anticonvulsants / adverse effects*,  therapeutic use
Child
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Epilepsy / drug therapy*
Humans
Nipecotic Acids / adverse effects*,  therapeutic use*
Placebos
Proportional Hazards Models
Treatment Outcome
gamma-Aminobutyric Acid / adverse effects*,  therapeutic use
Chemical
Reg. No./Substance:
0/Anticonvulsants; 0/Nipecotic Acids; 0/Placebos; 115103-54-3/tiagabine; 56-12-2/gamma-Aminobutyric Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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