γ‐Vinyl GABA (Vigabatrin) in Epilepsy: Clinical, Neurochemical, and Neurophysiologic Monitoring in Epileptic Patients

Ylinen, Aarne; Sivenius, Juhani; Pitkänen, Asla; Halonen, Toivo; Partanen, Juhani; Mervaala, Esa; Mumford, J. P.; Riekkinen, Paavo

doi:10.1111/j.1528-1157.1992.tb02201.x

Cited by 24 publications

(10 citation statements)

References 22 publications

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“…Our negative &dugs of evoked potentials are in accordance with stuhes in adults (6,11,22,25), in spite of our m d a n dose of 74 mg/'kg/day being considerably higher than previously mentioned (11,22). Only one study (6) included children, but only three, and in short-term (7 weeks) treatment.…”

Section: Discussionsupporting

confidence: 87%

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Vigabatrin in Childhood Epilepsy: A 5-Year Follow-Up Study

Uldall¹,

Alving²,

Gram³

et al. 1995

Neuropediatrics

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In an retrospective uncontrolled long-term study in 30 children with intractable epilepsy, it was found that treatment with vigabatrin resulted in a seizure reduction of more than 50% at 1-year follow-up in 40% of the children. The responders were all children with partial seizures. Side effects were mild and did not lead to discontinuation of the drug. Increased numbers of seizures were seen in three cases. A moderate weight increase was seen in 27% of the children. At 5-year follow-up 7 children (23%) still maintained a seizure reduction of more than 50%. Trials of monotherapy in three seizure-free patients were unsuccessful. No further side effects were observed. A study of evoked potentials in 12 children showed no alteration in latency and amplitudes of VEP following treatment with vigabatrin. Our results show that in children vigabatrin seems to have a stable effect even though a few children may experience a breakthrough of seizures. The presented results together with previous reports on MRI-scans seem to indicate that even in children with a still maturing CNS vigabatrin is a safe drug.

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Section: Discussionsupporting

confidence: 87%

“…In adults treated with vigabatrin no changes have been found in evoked potentials (25). No report on evoked potentials in children on vigabatrin has been published.…”

Section: Introductionmentioning

confidence: 96%

Vigabatrin in Childhood Epilepsy: A 5-Year Follow-Up Study

Uldall¹,

Alving²,

Gram³

et al. 1995

Neuropediatrics

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“…There are numerous published reports of the effects of VGB on EP in epilepsy patients (26,30,(57)(58)(59)(60)(61)(62)(63)(64). With follow-up periods of d 6 years, no changes suggestive of IME or drug-induced injury have been reported.…”

Section: Evoked Potentials In Humansmentioning

confidence: 99%

The Potential for Vigabatrin‐Induced Intramyelinic Edema in Humans

Cohen¹,

Fisher²,

Brigell³

et al. 2000

Epilepsia

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Purpose: Vigabatrin (Sabril, Hoechst Marion Roussel) is an antiepilepsy drug (AED) presently marketed in 64 countries for the treatment of partial and secondarily generalized seizures. Vigabatrin (VGB) is marketed in a subset of these countries for the treatment of infantile spasms. Clinical experience in humans has shown that VGB provides effective seizure control with a wide margin of safety. However, animal toxicity studies raised concern when prolonged administration of VGB was shown to induce intramyelinic edema (IME) in some laboratory animal species. Methods: Animal and human data were reviewed with respect to the potential for VGB-induced IME. Surveillance of patients receiving VGB in clinical trials or by prescription has been conducted for >15 years to identify patients developing clinical abnormalities that might be IME related. Results: The histologic lesions of VGB-induced IME in animals are reliably reproduced and correlate with changes in multimodality evoked potentials (EPs) and magnetic resonance imaging (MRI). Numerous studies of the effects of VGB on EP and MRI in epilepsy patients have demonstrated no clear-cut IME-related changes in these modalities. Additionally, autopsy and surgical brain samples from VGB-treated patients have been scrutinized for potential IME histopathology. In an estimated 350,000 patient-years of VGB exposure (-1 75,000 pa

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“…Owing either to noncompliance, patient tolerance, or side effects, the number of patients continuing with a given therapy after the acute phase of a study and realizing a significant benefit may diminish in time. Ylinen et al (1992) reported that of an original cohort of 75 refractory partial seizure patients receiving vigabatrin as add-on therapy, 55% realized >SO% decrease in seizures during the 3-month acute study; by 2 years, this decreased to 27%. Therefore, the safety and efficacy of therapies must be assessed over time.…”

mentioning

confidence: 99%

Vagus Nerve Stimulation for Treatment of Partial Seizures: 3. Long‐Term Follow‐Up on First 67 Patients Exiting a Controlled Study

et al. 1994

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Vagus nerve stimulation (VNS) has demonstrated a significant anticonvulsant effect in preclinical studies, in pilot studies in humans, and in the acute phase of a multicenter, double-blinded, randomized study. After completion of a 14-week, blinded, randomized study, with 31 receiving high (therapeutic) VNS and 36 receiving low (less or noneffective) VNS, 67 patients elected to continue in an open extension phase. During the extension phase, all 67 patients received high VNS. Seizure frequency during the 3-month treatment blocks was compared with a 12-week baseline. For both groups, all periods of high VNS demonstrated a significant decrease in seizure frequency (p < 0.01 level) as compared with baseline. For the 16-18-month period of VNS, data were available for 26 of the 31 patients randomized to high VNS. This group achieved a 52.0% mean seizure frequency percentage reduction as compared with baseline. For those converted from low to high VNS, data were available for 24 of the 36 patients at the 16-18-month time period. This group reported a mean seizure frequency percentage reduction of 38.1% as compared with baseline. No significant change in the safety/side effect profile was reported during long-term follow-up. The previously reported side effects of hoarseness/voice change, coughing, and paresthesia (sensation in neck and jaw) continued to occur during VNS. These side effects were well tolerated. During the follow-up period, 1 patient died of thrombotic thrombocytopenic purpura (TTP) and 5 patients discontinued treatment because of unsatisfactory efficacy.

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γ‐Vinyl GABA (Vigabatrin) in Epilepsy: Clinical, Neurochemical, and Neurophysiologic Monitoring in Epileptic Patients

Cited by 24 publications

References 22 publications

Vigabatrin in Childhood Epilepsy: A 5-Year Follow-Up Study

Vigabatrin in Childhood Epilepsy: A 5-Year Follow-Up Study

The Potential for Vigabatrin‐Induced Intramyelinic Edema in Humans

Vagus Nerve Stimulation for Treatment of Partial Seizures: 3. Long‐Term Follow‐Up on First 67 Patients Exiting a Controlled Study

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