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Randomized Controlled Trial
. 2022 Aug;43(8):5133-5141.
doi: 10.1007/s10072-022-06121-9. Epub 2022 Jun 1.

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

Edoardo Ferlazzo #  1   2 , Giorgia Giussani #  3 , Sara Gasparini #  1   2 , Elisa Bianchi  3 , Vittoria Cianci  2 , Vincenzo Belcastro  4 , Roberto Cantello  5 , Gionata Strigaro  5 , Matilde Lazzari  5 , Amedeo Bianchi  6 , Martina Guadagni  6 , Silvia Pradella  6 , Angela La Neve  7 , Teresa Francavilla  7 , Nicola Pilolli  7 , Paola Banfi  8 , Francesco Turco  8 , Marta Piccioli  9 , Luigi Polidori  9 , Teresa Anna Cantisani  10 , Rossella Papetti  10 , Michela Cecconi  10 , Elisabetta Pupillo  3 , Emilio Davide Arippol  3 , Gabriele Enia  3 , Sabrina Neri  1   2 , Umberto Aguglia  11   12 , Ettore Beghi  3
Affiliations
Randomized Controlled Trial

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

Edoardo Ferlazzo et al. Neurol Sci. 2022 Aug.

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.

Keywords: Antiseizure medication; Drug withdrawal; Seizure freedom; Seizure relapse; Tapering.

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References

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