title: Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: an Italian multicenter prospective observational study.
abstract: A prospective multicenter observational study was undertaken on children and adults with epilepsy in whom first monotherapy failed, to assess indications and effects of alternative monotherapy vs. polytherapy. Patients were followed until 12-month remission, drug withdrawal, or up to 18months. Monotherapy and polytherapy were compared for patients' baseline features, indication, retention time, remission, adverse events (AE), quality of life, and direct and indirect costs. Included were 157 men and 174 women, aged 2-86years. Of the patients, 72.2% were switched to alternative monotherapy. Baseline treatment was changed for lack of efficacy (73.9%) or adverse events (26.1%). Two hundred forty-three completed the study (remission: 175; 72.0%). Retention time, hospital admissions, days off-work and off-school, and quality of life did not differ between the two treatment groups. Patients were followed for 365.3person-years. Three hundred eighty-three incident AEs were reported by 46.4% of patients in monotherapy and 40.2% in polytherapy (serious AEs: 9.6% vs. 8.7%, mostly nondrug-related).
authors.affiliation: Laboratorio di Malattie Neurologiche, IRCCS, Istituto Mario Negri di Milano, Italy. andrea.millul@marionegri.it
authors.forename: Andrea
authors.initials: A
authors.lastname: Millul
authors.forename: Alfonso
authors.initials: A
authors.lastname: Iudice
authors.forename: Marina
authors.initials: M
authors.lastname: Adami
authors.forename: Roberto
authors.initials: R
authors.lastname: Porzio
authors.forename: Flavia
authors.initials: F
authors.lastname: Mattana
authors.forename: Ettore
authors.initials: E
authors.lastname: Beghi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D055815:Young Adult
chemical_list: D000927:Anticonvulsants
keywords: Cohort study; Epilepsy; Monotherapy; Polytherapy