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Titolo:
DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF TOPIRAMATE (600 MG DAILY) FOR THE TREATMENT OF REFRACTORY PARTIAL EPILEPSY
Autore:
TASSINARI CA; MICHELUCCI R; CHAUVEL P; CHODKIEWICZ J; SHORVON S; HENRIKSEN O; DAM M; REIFE R; PLEDGER G; KARIM R;
Indirizzi:
UNIV BOLOGNA,BELLARIA HOSP,DEPT NEUROL SCI,VIA ALTURA 3 I-40139 BOLOGNA ITALY BELLARIA HOSP,INST CLIN NEUROL BOLOGNA ITALY HOP ST ANNE F-75674 PARIS FRANCE CHU PONTCHAILLOU,SERV NEUROL RENNES FRANCE NATL HOSP LONDON WC1N 3BG ENGLAND NATL CTR EPILEPSY SANDVIKA NORWAY HVIDOVRE UNIV HOSP,NEUROL CLIN DK-2650 HVIDOVRE DENMARK RW JOHNSON PHARMACEUT RES INST SPRING HOUSE PA 19477 RW JOHNSON PHARMACEUT RES INST RARITAN NJ 08869
Titolo Testata:
Epilepsia
fascicolo: 8, volume: 37, anno: 1996,
pagine: 763 - 768
SICI:
0013-9580(1996)37:8<763:DPTOT(>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Keywords:
TOPIRAMATE; ANTIEPILEPTIC DRUG; PARTIAL EPILEPSY; SECONDARILY GENERALIZED EPILEPSY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
18
Recensione:
Indirizzi per estratti:
Citazione:
C.A. Tassinari et al., "DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF TOPIRAMATE (600 MG DAILY) FOR THE TREATMENT OF REFRACTORY PARTIAL EPILEPSY", Epilepsia, 37(8), 1996, pp. 763-768

Abstract

Purpose: We wished to evaluate adjunctive therapy for partial-onset seizures with topiramate (TPM) for efficacy and safety in a double-blind, placebo-controlled, randomized, parallel-group study. Methods: Sixty outpatients with epilepsy (47 men and 13 women, mean age 32.9 years)were studied. All had a documented history of partial-onset seizures with or without secondarily generalized seizures. After an 8-week baseline during which patients had at least one seizure per week, 30 patients each were randomized to TPM 300 mg twice daily (b.i.d.) or placebofor 12 weeks. Results: TPM was significantly superior to placebo, as indicated by all efficacy assessments: greater median percent reduction from baseline in the average monthly seizure rate (46 vs. - 12%, p =0.004); greater number of treatment responders (patients with greaterthan or equal to 50% reduction in seizure rate) (47 vs. 10%, p = 0.001), and better investigator (p = 0.002) and patient (p = 0.010) globalassessments of treatment. Among TPM-treated patients, the most commonly reported adverse events (AE) were headache, somnolence, fatigue, dizziness, and abnormal thinking, Most AE were mild or moderate in severity. Conclusions: The results of the present trial indicate that TPM 600 mg/day is effective in the treatment of refractory partial-onset seizures with or without secondarily generalized seizures.

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Documento generato il 30/10/20 alle ore 09:57:42