PMID- 32040850 OWN - NLM STAT- MEDLINE DCOM- 20210611 LR - 20210611 IS - 1179-1934 (Electronic) IS - 1172-7047 (Linking) VI - 34 IP - 3 DP - 2020 Mar TI - Adjunctive Cannabidiol in Patients with Dravet Syndrome: A Systematic Review and Meta-Analysis of Efficacy and Safety. PG - 229-241 LID - 10.1007/s40263-020-00708-6 [doi] AB - BACKGROUND: Dravet syndrome (DS) is one of the most severe forms of drug-resistant epilepsy and available interventions fail to control seizures in most patients. Cannabidiol (CBD) is the first in a new class of antiepileptic drugs with a distinctive chemical structure and mechanism of action. OBJECTIVE: The aim of this systematic review was to evaluate the efficacy and safety of CBD as adjunctive treatment for seizures in patients with DS using meta-analytical techniques. METHODS: We searched for randomized, placebo-controlled, single- or double-blinded trials. Main outcomes included >/= 50% reduction in baseline convulsive seizure frequency and the incidence of treatment withdrawal and adverse events (AEs). Risk ratios (RRs) with 95% confidence intervals (95% CIs) were estimated through the inverse variance method. RESULTS: Three trials were included involving 359 participants, 228 for CBD and 131 for placebo groups. In all trials, the active treatment was a plant-derived pharmaceutical formulation of purified CBD oral solution. The pooled RR for 50% response during the treatment was 1.69 (95% CI 1.21-2.36; p = 0.002). Across the trials, treatment was discontinued in 20 (9.0%) and 3 (2.3%) cases in the add-on CBD and placebo groups, respectively; the RR for CBD withdrawal was 3.12 (95% CI 1.07-9.10; p = 0.037). The RR to develop any AE during add-on CBD treatment was 1.06 (95% CI 0.87-1.28; p = 0.561). AEs significantly associated with adjunctive CBD were somnolence, decreased appetite, diarrhea, and increased serum aminotransferases. CONCLUSIONS: Adjunctive CBD resulted in a greater reduction in convulsive seizure frequency than placebo and a higher rate of AEs in patients with DS presenting with seizures uncontrolled by concomitant antiepileptic therapy. FAU - Lattanzi, Simona AU - Lattanzi S AUID- ORCID: 0000-0001-8748-0083 AD - Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca71, 60020, Ancona, Italy. alfierelattanzisimona@gmail.com. FAU - Brigo, Francesco AU - Brigo F AD - Department of Neuroscience, Biomedicine and Movement Science, University of Verona, Verona, Italy. AD - Division of Neurology, "Franz Tappeiner" Hospital, Merano, BZ, Italy. FAU - Trinka, Eugen AU - Trinka E AD - Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria. AD - Center for Cognitive Neuroscience, Salzburg, Austria. AD - Public Health, Health Services Research and HTA, University for Health Sciences, Medical Informatics and Technology, Hall i. T, Austria. FAU - Zaccara, Gaetano AU - Zaccara G AD - Health Agency of Tuscany, Florence, Italy. FAU - Striano, Pasquale AU - Striano P AD - Pediatric Neurology and Muscular Diseases Unit, Department of Neurosciences, Rehabilitation, Ophthalmology Genetics, Maternal and Child Health, "G. Gaslini" Institute, University of Genoa, Genoa, Italy. FAU - Del Giovane, Cinzia AU - Del Giovane C AD - Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. FAU - Silvestrini, Mauro AU - Silvestrini M AD - Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca71, 60020, Ancona, Italy. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review PL - New Zealand TA - CNS Drugs JT - CNS drugs JID - 9431220 RN - 19GBJ60SN5 (Cannabidiol) SB - IM MH - Cannabidiol/*adverse effects/*therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination/methods MH - Epilepsies, Myoclonic/*drug therapy MH - Humans MH - Odds Ratio MH - Randomized Controlled Trials as Topic EDAT- 2020/02/11 06:00 MHDA- 2021/06/12 06:00 CRDT- 2020/02/11 06:00 PHST- 2020/02/11 06:00 [pubmed] PHST- 2021/06/12 06:00 [medline] PHST- 2020/02/11 06:00 [entrez] AID - 10.1007/s40263-020-00708-6 [pii] AID - 10.1007/s40263-020-00708-6 [doi] PST - ppublish SO - CNS Drugs. 2020 Mar;34(3):229-241. doi: 10.1007/s40263-020-00708-6.