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Titolo:
EVALUATION OF DRUG-TREATMENT OUTCOME IN EPILEPSY - A CLINICAL PERSPECTIVE
Autore:
PERUCCA E;
Indirizzi:
UNIV PAVIA,DEPT PHARMACOL & THERAPEUT,CLIN PHARMACOL UNIT,PIAZZA BOTTA 10 I-27100 PAVIA ITALY
Titolo Testata:
Pharmacy world & science
fascicolo: 5, volume: 19, anno: 1997,
pagine: 217 - 222
SICI:
0928-1231(1997)19:5<217:EODOIE>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
MULTICENTER COMPARATIVE TRIAL; COMPARATIVE MONOTHERAPY TRIAL; NEWLY-DIAGNOSED EPILEPSY; SEIZURE SEVERITY SCALE; PARTIAL-ONSET SEIZURES; TONIC CLONIC SEIZURES; QUALITY-OF-LIFE; SODIUM VALPROATE; FELBAMATE MONOTHERAPY; ANTIEPILEPTIC DRUGS;
Keywords:
ANTIEPILEPTIC DRUGS; CONTROLLED TRIALS; EFFICACY; OUTCOME MEASURES; SEIZURES; SAFETY; SIDE EFFECT; TRIAL DESIGN;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
46
Recensione:
Indirizzi per estratti:
Citazione:
E. Perucca, "EVALUATION OF DRUG-TREATMENT OUTCOME IN EPILEPSY - A CLINICAL PERSPECTIVE", Pharmacy world & science, 19(5), 1997, pp. 217-222

Abstract

This article provides a comprehensive discussion of clinical outcome measures used in trials aimed at assessing the efficacy and safety of antiepileptic drugs. For efficacy, assessment still relies on careful documentation of changes in ictal as determined by seizure counts based on patientss recall, direct clinical observation and (for absence seizures ) EEG monitoring. In selected cases, assessment of seizure severity may also be indicated. The precise choice of outcome measures is largerly dependent upon the specific trial design. In short-term regulatory trials,parameters such as time to nth seizure after randomization (or after achievement of target dosage) may be used as an index of antiepileptic efficacy, but the clinical relevance of such measures is questionable. In add-on trials in refractory patients, changes in seizure counts and proportion of patients achieving 50%, 75% and 100% reduction in seizure frequency may be appropriate. For long-term monotherapy trials in newly diagnosed patients, proportion of patients achieving prolonged remission (1-year or longer) usually represents the most clinically meaningful efficacy outcome, Retention of patients on the allocated treatment over time is also a valuable measure, but it should be regarded as a composite endpoint because decision to continue treatment is dependent on both efficacy and tolerability. At present, thereis no universally accepted method for evaluating side effects, particularly those which can not be documented objectively. Spontaneous reports of symptoms or use of specific checklists have advantages and disadvantages. Studies aimed at ensuring greater standardization in safetyassesment should be encouraged, especially with respect to need of obtaining quantitative estimates, and information on both prevalence andincidence of side effects should be reported in all trials.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/11/20 alle ore 02:01:14