title: Rapid versus slow withdrawal of antiepileptic monotherapy in 2-year seizure-free adult patients with epilepsy (RASLOW) study: a pragmatic multicentre, prospective, randomized, controlled study.
abstract: Antiepileptic drug withdrawal may be an option for patients who have been seizure free for some years. The best withdrawal rate is questionable; in particular, it is unknown whether "rapid" withdrawal is associated with a higher risk of relapse as compared to "slow" withdrawal. We aim to establish if a slow or a rapid withdrawal schedule of antiepileptic monotherapy influences relapse rate in adult patients with focal or generalized epilepsy who have been seizure free for at least 2 years. This multicentre, prospective, randomized controlled study will enroll adult patients with focal or generalized epilepsy, who are seizure free on monotherapy. Patients will be randomized to a slow (160 days) or a rapid (60 days) schedule. Follow-up will last 1 year after randomization. The primary endpoint is the time to seizure relapse; secondary endpoints are compliance to the assigned schedule, occurrence of status epilepticus, of seizure-related injuries and mortality. A sample size of 350 patients has been planned. Univariate and multivariate analysis by Kaplan-Meier curves and Cox regression (primary endpoint) and by logistic regression (secondary endpoint) will be performed. The present study should contribute to better define the best withdrawal period for AED treatment in adult patients with epilepsy.
authors.affiliation: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro, Via Melacrino, 89100, Reggio Calabria, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Gasparini
authors.affiliation: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro, Via Melacrino, 89100, Reggio Calabria, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Ferlazzo
authors.affiliation: Laboratory of Neurological Disorders, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Giussani
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Italiano
authors.affiliation: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro, Via Melacrino, 89100, Reggio Calabria, Italy.
authors.forename: Vittoria
authors.initials: V
authors.lastname: Cianci
authors.affiliation: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro, Via Melacrino, 89100, Reggio Calabria, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Sueri
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Spina
authors.affiliation: Laboratory of Neurological Disorders, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Beghi
authors.affiliation: Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro, Via Melacrino, 89100, Reggio Calabria, Italy. u.aguglia@tin.it.
authors.forename: Umberto
authors.initials: U
authors.lastname: Aguglia
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D016016:Proportional Hazards Models; D012640:Seizures / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants
keywords: Anti epileptic drug; Randomized controlled trial; Rapid withdrawal; Slow withdrawal
references.citation: Epilepsia. 2013 Oct;54 Suppl 7:2-12
references.pmid: 24099051
references.citation: Epilepsia. 2010 Jan;51(1):37-42
references.pmid: 19490039
references.citation: N Engl J Med. 1988 Apr 14;318(15):942-6
references.pmid: 3127710
references.citation: Ann Neurol. 1994 May;35(5):534-45
references.pmid: 8179299
references.citation: Epilepsia. 2008 Mar;49(3):455-63
references.pmid: 17888074
references.citation: CNS Drugs. 2004;18(4):201-12
references.pmid: 15015901
references.citation: Epilepsia. 2002 Sep;43(9):1076-83
references.pmid: 12199734
references.citation: Neurology. 1994 Apr;44(4):601-8
references.pmid: 8164811
references.citation: Epilepsia. 1998 Jan;39(1):81-8
references.pmid: 9578017
references.citation: N Engl J Med. 2000 Feb 3;342(5):314-9
references.pmid: 10660394
references.citation: N Engl J Med. 1981 May 7;304(19):1125-9
references.pmid: 7219445
references.citation: Epilepsy Res. 1987 Nov-Dec;1(6):357-64
references.pmid: 3504410
references.citation: N Engl J Med. 1994 May 19;330(20):1407-10
references.pmid: 8159193
references.citation: Epilepsia. 2004 Jun;45(6):667-72
references.pmid: 15144432
references.citation: Epilepsia. 1989 Jul-Aug;30(4):389-99
references.pmid: 2502382
references.citation: Eur Neurol. 1992;32(3):141-5
references.pmid: 1592070