Simona Lattanzi1, Eugen Trinka2,3,4, Pasquale Striano5, Gaetano Zaccara6, Cinzia Del Giovane7, Raffaele Nardone2,8, Mauro Silvestrini1, Francesco Brigo8,9. 1. Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy. 2. Department of Neurology, Christian Doppler Clinic, Paracelsus Medical University, Salzburg, Austria. 3. Center for Cognitive Neuroscience, Salzburg, Austria. 4. Public Health, Health Services Research, and Health Technology Assessment, University for Health Sciences, Medical Informatics, and Technology, Hall in Tyrol, Austria. 5. Pediatric Neurology and Muscular Diseases Unit, Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, G. Gaslini Institute, University of Genoa, Genoa, Italy. 6. Health Agency of Tuscany, Florence, Italy. 7. Institute of Primary Health Care, Bernese Institute of Family Medicine, University of Bern, Bern, Switzerland. 8. Department of Neuroscience, Biomedicine, and Movement Science, University of Verona, Verona, Italy. 9. Division of Neurology, Franz Tappeiner Hospital, Merano, Italy.
Abstract
OBJECTIVE: To evaluate the potential impact of concomitant clobazam (CLB) use on the efficacy of cannabidiol (CBD) treatment in patients with Dravet syndrome and Lennox-Gastaut syndrome using meta-analytical techniques. METHODS: We searched for randomized, placebo-controlled, single- or double-blinded trials. The proportion of patients who achieved ≥50% reduction from baseline in seizure frequency during the treatment period was assessed according to CLB status. Risk ratios (RRs) with 95% confidence intervals (CIs) were estimated. RESULTS: Four trials were included and enrolled 714 participants, 429 for the add-on CBD group and 285 for the add-on placebo group. Among CBD-treated patients, 240 (55.9%) were taking concomitant CLB (CLB-On) and 189 (44.1%) were not taking concomitant CLB (CLB-Off); in placebo-treated patients, 158 (55.4%) were CLB-On and 127 (44.6%) CLB-Off. The percentages of patients who had at least 50% reduction in seizure frequency during the treatment period were 29.1% in the CBD arm and 15.7% in the placebo group among CLB-Off patients (RR = 1.80, 95% CI = 1.12-2.90, P = .015). Among CBL-On patients, the ≥50% reduction in seizure frequency was found in 52.9% and 27.8% in the CBD and placebo groups, respectively (RR = 1.85, 95% CI = 1.40-2.44, P < .001). SIGNIFICANCE: CBD was associated with a higher rate of seizure response in comparison to placebo when added to the existing antiepileptic regimen both in patients taking and in those not taking concomitant CLB. The lack of randomization for CLB status and the limited sample size need to be considered in the interpretation of the findings.
OBJECTIVE: To evaluate the potential impact of concomitant clobazam (CLB) use on the efficacy of cannabidiol (CBD) treatment in patients with Dravet syndrome and Lennox-Gastaut syndrome using meta-analytical techniques. METHODS: We searched for randomized, placebo-controlled, single- or double-blinded trials. The proportion of patients who achieved ≥50% reduction from baseline in seizure frequency during the treatment period was assessed according to CLB status. Risk ratios (RRs) with 95% confidence intervals (CIs) were estimated. RESULTS: Four trials were included and enrolled 714 participants, 429 for the add-on CBD group and 285 for the add-on placebo group. Among CBD-treated patients, 240 (55.9%) were taking concomitant CLB (CLB-On) and 189 (44.1%) were not taking concomitant CLB (CLB-Off); in placebo-treated patients, 158 (55.4%) were CLB-On and 127 (44.6%) CLB-Off. The percentages of patients who had at least 50% reduction in seizure frequency during the treatment period were 29.1% in the CBD arm and 15.7% in the placebo group among CLB-Offpatients (RR = 1.80, 95% CI = 1.12-2.90, P = .015). Among CBL-On patients, the ≥50% reduction in seizure frequency was found in 52.9% and 27.8% in the CBD and placebo groups, respectively (RR = 1.85, 95% CI = 1.40-2.44, P < .001). SIGNIFICANCE: CBD was associated with a higher rate of seizure response in comparison to placebo when added to the existing antiepileptic regimen both in patients taking and in those not taking concomitant CLB. The lack of randomization for CLB status and the limited sample size need to be considered in the interpretation of the findings.
Authors: Luigi Francesco Iannone; Gabriele Arena; Domenica Battaglia; Francesca Bisulli; Paolo Bonanni; Antonella Boni; Maria Paola Canevini; Gaetano Cantalupo; Elisabetta Cesaroni; Manuela Contin; Antonietta Coppola; Duccio Maria Cordelli; Giovanni Cricchiuti; Valentina De Giorgis; Maria Fulvia De Leva; Marta De Rinaldis; Giuseppe d'Orsi; Maurizio Elia; Carlo Andrea Galimberti; Alessandra Morano; Tiziana Granata; Renzo Guerrini; Monica A M Lodi; Angela La Neve; Francesca Marchese; Silvia Masnada; Roberto Michelucci; Margherita Nosadini; Nicola Pilolli; Dario Pruna; Francesca Ragona; Anna Rosati; Margherita Santucci; Alberto Spalice; Nicola Pietrafusa; Pasquale Striano; Elena Tartara; Laura Tassi; Amanda Papa; Claudio Zucca; Emilio Russo; Oriano Mecarelli Journal: Front Neurol Date: 2021-05-20 Impact factor: 4.003
Authors: Boudewijn Gunning; Maria Mazurkiewicz-Bełdzińska; Richard F M Chin; Hari Bhathal; Charlotte Nortvedt; Eduardo Dunayevich; Daniel Checketts Journal: Acta Neurol Scand Date: 2020-10-22 Impact factor: 3.209