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01-06-2022 | Antiepileptic Drugs | Clinical Trial article

Rapid versus slow withdrawal of antiepileptic monotherapy in two-year seizure-free adults patients with epilepsy (RASLOW) study: A pragmatic multicentre, prospective, randomized, controlled study

Authors: Edoardo Ferlazzo, Giorgia Giussani, Sara Gasparini, Elisa Bianchi, Vittoria Cianci, Vincenzo Belcastro, Roberto Cantello, Gionata Strigaro, Matilde Lazzari, Amedeo Bianchi, Martina Guadagni, Silvia Pradella, Angela La Neve, Teresa Francavilla, Nicola Pilolli, Paola Banfi, Francesco Turco, Marta Piccioli, Luigi Polidori, Teresa Anna Cantisani, Rossella Papetti, Michela Cecconi, Elisabetta Pupillo, Emilio Davide Arippol, Gabriele Enia, Sabrina Neri, Umberto Aguglia, Ettore Beghi

Published in: Neurological Sciences | Issue 8/2022

Abstract

Purpose

To establish whether a slow or a rapid withdrawal of antiepileptic monotherapy influences relapse rate in seizure-free adults with epilepsy and calculates compliance and differences in the severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries, and death.

Methods

This is a multicentre, prospective, randomized, open label, non-inferiority trial in people aged 16 + years who were seizure-free for more than 2 years. Patients were randomized to slow withdrawal (160 days) or rapid withdrawal (60 days) and were followed for 12 months. The primary outcome was the probability of a first seizure relapse within the 12-months follow-up. The secondary outcomes included the cumulative probability of relapse at 3, 6, 9, and 12 months. A non-inferiority analysis was performed with non-inferiority margin of − 0.15 for the difference between the probabilities of seizure recurrence in slow versus rapid withdrawal.

Results

The sample comprised 48 patients, 25 randomized to slow withdrawal and 23 to rapid withdrawal. Median follow-up was 11.9 months. In the intention-to-treat population, 3 patients in the slow-withdrawal group and 1 in the rapid withdrawal group experienced seizure relapses. The corresponding probabilities of seizure recurrence were 0.12 for slow withdrawal and 0.04 for rapid withdrawal, giving a difference of 0.08 (95% CI − 0.12; 0.27), which is entirely above the non-inferiority margin. No patients developed status epilepticus and seizure-related injuries or died. Risks were similar in the Per-Protocol population.

Conclusions

Seizure-relapse rate after drug discontinuation is lower than in other reports, without complications and unrelated to the duration of tapering.

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Title: Rapid versus slow withdrawal of antiepileptic monotherapy in two-year seizure-free adults patients with epilepsy (RASLOW) study: A pragmatic multicentre, prospective, randomized, controlled study
Authors: Edoardo Ferlazzo
Giorgia Giussani
Sara Gasparini
Elisa Bianchi
Vittoria Cianci
Vincenzo Belcastro
Roberto Cantello
Gionata Strigaro
Matilde Lazzari
Amedeo Bianchi
Martina Guadagni
Silvia Pradella
Angela La Neve
Teresa Francavilla
Nicola Pilolli
Paola Banfi
Francesco Turco
Marta Piccioli
Luigi Polidori
Teresa Anna Cantisani
Rossella Papetti
Michela Cecconi
Elisabetta Pupillo
Emilio Davide Arippol
Gabriele Enia
Sabrina Neri
Umberto Aguglia
Ettore Beghi
Publication date: 01-06-2022
Publisher: Springer International Publishing
Keywords: Antiepileptic Drugs
Status Epilepticus
Epilepsy
Antiepileptic Drugs
Published in: Neurological Sciences / Issue 8/2022
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-022-06121-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Rapid versus slow withdrawal of antiepileptic monotherapy in two-year seizure-free adults patients with epilepsy (RASLOW) study: A pragmatic multicentre, prospective, randomized, controlled study

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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