Results of a Consensus Conference on 11 Third 2000 in Frankfurt am Main.
The experience of recent years that it may occur during treatment with vigabatrin on the occurrence of concentric visual field defects, led to a reassessment of the risk-benefit ratio and make recommendations regarding the treatment of patients with epilepsy with vigabatrin and appropriate therapy monitoring. The company Aventis Pharma Germany GmbH for this purpose on the 11th Third 2000 Epilepsy experts invited to the following opinion expressed.
It is slightly less effective than the primary ACTH therapy, but has a significantly lower relapse rate and is better tolerated.
Vigabatrin is thus on the use of high doses of vitamin B6 a drug of first choice for treatment of West syndrome.
At 1 - 10% occur including weight gain, depression, nervousness and paranoid reactions. Special, very frequent, usually reversible side effects of vigabatrin therapy are at the beginning of treatment fatigue and agitation in children. Rarely there may be peripheral retinal atrophy and in some cases, optic neuritis and optic atrophy.
According to current knowledge, it comes in the course of treatment in about 30% of all adults still unexplained to concentric visual field defects, which do not usually cause problems. A reversible after discontinuation has so far been observed only in individual cases.
Whether the Vigabatrinbehandlung causes of childhood visual field defects at a similar rate, is currently due to lack of study opportunities not exactly known.
The occurrence of visual field defects with vigabatrin therapy following procedure for the use and monitoring of treatment with vigabatrin is recommended:
Patients or their families are fully informed of the epilepsy and the risk-benefit profile of vigabatrin, including the usually irreversible, partly concentric informed and usually without symptoms associated visual field defects.
The benefit-risk balance of Vigabatrintherapie can also despite the risk of visual field defects previously treated unsuccessfully with his positive partial seizures with or without secondary generalization, if all other appropriate antiepileptic drugs have proven to be not sufficiently effective or not tolerated.
The vigabatrin monotherapy has in the treatment of West syndrome continues to be a positive benefit-risk ratio compared to other therapies.
Treatment with vigabatrin in West syndrome should not be extended over three weeks in ineffectiveness. This potential risk is limited to the treatment with a clear benefit.
All patients should be discontinued before treatment with vigabatrin and after 1 - 2 months to be examined visual field defects. Pathological findings are reviewed during the therapy needs. For negative finding should further control after 3 - done 6 months, then every six months initially.
Each patient should be informed to report to the occurrence of new visual disturbances immediately. We recommend participation in the patient-information program of the manufacturer.
Patients who are not able to attend, or a visual field test, children under a developmental age of 9 years not currently be reliably evaluated.
Are already in pre-treated with vigabatrin patients with abnormal visual field findings must be first considered whether further treatment is advisable. With a negative benefit-risk assessment, either because of lack of efficacy or adverse effects, the daily dose of vigabatrin is preferably slowly, eg in adults mg every two weeks reduced by 500. After settling, the field is to be determined again.
In conclusion, vigabatrin currently, despite the risk of visual field defects with otherwise good compatibility, good efficacy and favorable pharmacokinetics indicated as adjunctive treatment of patients with intractable focal epilepsy, if drug resistance is compared with the available drug alternatives and an epilepsy surgery is not in issue or unsuccessful was.
The vigabatrin monotherapy remains a drug of first choice in the treatment of West syndrome and in comparison to other therapies, a positive benefit-risk ratio.