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Non-vision adverse events with vigabatrin therapy
Acta neurologica Scandinavica, 2011-12, Vol.124 (s192), p.72-82
Walker, S. D.
Kälviäinen, R.
2011
Details
Autor(en) / Beteiligte
Walker, S. D.
Kälviäinen, R.
Titel
Non-vision adverse events with vigabatrin therapy
Ist Teil von
Acta neurologica Scandinavica, 2011-12, Vol.124 (s192), p.72-82
Ort / Verlag
Oxford, UK: Blackwell Publishing Ltd
Erscheinungsjahr
2011
Link zum Volltext
Quelle
Wiley Online Library Journals Frontfile Complete
Beschreibungen/Notizen
Walker SD, Kälviäinen R. Non‐vision adverse events with vigabatrin therapy. Acta Neurol Scand: 2011: 124 (Suppl. 192): 72–82. © 2011 John Wiley & Sons A/S. Vigabatrin is an effective antiepileptic drug (AED) for the treatment of refractory complex partial seizures (rCPS) and infantile spasms (IS). In clinical trials, vigabatrin was generally well‐tolerated with an adverse event profile similar to that of other AEDs. The most common treatment‐related adverse events were central nervous system effects, including drowsiness, dizziness, headache, and fatigue, with adjunctive vigabatrin in adults with rCPS, and sedation, somnolence, and irritability with vigabatrin monotherapy in infants with IS. Vigabatrin had little effect on cognitive function, mood, or behavior in a battery of neuropsychologic tests for rCPS. In placebo‐controlled clinical trials, the incidence of depression and psychosis, but not other psychiatric adverse events, was greater with vigabatrin than placebo. Intramyelinic edema (IME) was initially identified in rats and dogs and led to a temporary suspension of clinical trials in the United States. IME was subsequently correlated with delays in evoked potential (EP) and increased T2‐weighted signals on magnetic resonance imaging (MRI). Clinical trials of vigabatrin were allowed to resume after IME was not detected by neuropathologic assessments of autopsy and neurosurgical specimens or by serial EP or MRI assessments in older children and adults receiving vigabatrin. Subsequently, MRI abnormalities characterized by increased T2 intensity and restricted diffusion were identified in infants treated with vigabatrin for IS. These abnormalities generally resolved with discontinuation of vigabatrin and, in some cases, during continued therapy. The benefit of improved seizure control must be balanced against the potential risks associated with vigabatrin, including abnormal MRI changes and other vigabatrin‐related safety issues.
Sprache
Englisch
Identifikatoren
ISSN: 0001-6314
eISSN: 1600-0404, 1600-5449
DOI: 10.1111/j.1600-0404.2011.01602.x
Titel-ID: cdi_proquest_miscellaneous_902810807
Format
–
Schlagworte
4-Aminobutyrate Transaminase - antagonists & inhibitors
,
Adolescent
,
Adult
,
adverse events
,
Animals
,
Anticonvulsants - adverse effects
,
Brain Diseases - chemically induced
,
Brain Diseases - diagnosis
,
Cognition Disorders - chemically induced
,
complex partial seizures
,
Edema - chemically induced
,
Epilepsies, Partial - drug therapy
,
evoked potential
,
Evoked Potentials, Somatosensory - drug effects
,
Fatigue - chemically induced
,
Fever - chemically induced
,
Headache - chemically induced
,
Humans
,
Infant
,
infantile spasms
,
intramyelinic edema
,
Irritable Mood - drug effects
,
Magnetic Resonance Imaging
,
Myelin Sheath - drug effects
,
Myelin Sheath - ultrastructure
,
Nasopharyngitis - chemically induced
,
Otitis Media - chemically induced
,
refractory epilepsy
,
Respiratory Tract Infections - chemically induced
,
review
,
Sleep Wake Disorders - chemically induced
,
Spasms, Infantile - drug therapy
,
Tremor - chemically induced
,
vigabatrin
,
Vigabatrin - adverse effects
,
Virus Diseases - chemically induced
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