Titular de Autorización de Registro y Comercialización (TARC): Alef Medical Argentina S.A.
Equipo de Farmacovigilancia/IPRAT S.A.
Fecha: 01-Abril-2022
En el marco del Simposio LACE llevado a cabo el 17 de septiembre 2021, la Dra. Helen Cross, Presidente de la Liga Internacional contra la Epilepsia (ILAE), dio una charla donde expuso la siguiente temática: “Uso de cannabinoides en el tratamiento de la epilepsia”.
El Dr. Roberto Caraballo (MN 61.757) Medico Especialista en Neurología Infantil y Epilepsia, Jefe del Servicio de Neurología del Hospital Garrahan y Vicepresidente de la Liga Mundial contra la Epilepsia (ILAE), participa del Panel de Expertos del webinar organizado por el Departamento de Neuropediatra del Instituto Nacional de Ciencias Neurológicas de la ciudad de Lima en Perú, llevado a cabo el 8 de septiembre de 2021.
Su exposición giró en torno de la siguiente temática: “Uso del Cannabidiol en la Epilepsia: Un Futuro Promisorio o Una Realidad”.
En el marco del Simposio LACE llevado a cabo el 17 de septiembre 2021, el Dr. Orrin Devinsky, Profesor de Neurología, Neurociencias, Psiquiatría y Neurocirugía de la Facultad de Medicina de New York, dio una charla donde expuso la siguiente temática: “Cannabis en el uso de epilepsia y otras indicaciones”.
Estudio de eficacia de cannabidiol en epilepsia refractaria por esclerosis tuberosa, con dosis de 25mg/k/d y 50 mg/kg/d vs placebo.Add-on Cannabidiol Treatment for Drug-Resistant Seizures
https://jamanetwork.com/journals/jamaneurology/fullarticle/2774314?guestAccessKey=b299f92d-1ee8-4878-87d7-a69230398c86&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamaneurology&utm_content=etoc&utm_term=031121
Summary:
In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg or placebo, in addition to standard antiepileptic treatment. 14-week treatment period.
Results: The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo. The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo
Devinsky et al. N Engl J Med 2017;376:2011-20.
Summary:
In this paper, Dr. Helen Cross, warns about the risks of artisanal preparations, not only due to the impossibility to check the amount of CBD per flask and its stability but because of the risk of inconsistency or unknown constituents. Because of the characteristics and the elaboration of these flasks it is impossible to perform clinical studies to compare them with pharmaceutical products with GMP
1. J Helen Cross , Hannah Cock. A Perspective on Cannabinoids for Treating Epilepsy: Do They Really Change the Landscape? Neuropharmacology 2020 Jun 15;170:107861.
Summary:
Review on the “state of art” of Cannabis and epilepsy, warns about the differences between pharmaceutical cannabis and artisanal preparations. Concludes by suggesting to separate ourselves from our thoughts about artisanal preparations. Cannabidiol oils rigorously tested in clinical trials.
https://pn.bmj.com/content/early/2018/10/18/practneurol-2018-002058.info?versioned=true
Work made by researchers of UPenn in JAMA who performed a comparison between contents of commercialized products, founding great discrepancies between what was initially announced and the eventual results. The discrepancies was found both in the CBD and the THC. It outstands the importance of standardizing manufacturing processes.
https://jamanetwork.com/journals/jama/article-abstract/2661569
Summary:
Work by Crippa and others, reporting 2 cases of THC intoxication due to artisanal preparations. It highlights the importance of access to GMP products. It also mentions the risks of using of artisanal oils in teens and children because of the known damage produced by Δ9-THC in the developing brain.
Summary:
News about the work presented in the American Academy of Neurology 72nd Annual Meeting in Toronto, Canada, April 25 to May 1, 2020. With regards to the difference of impact between home-made products containing CBD and pharmaceutical products. There was higher efficacy noticed in pharmaceutical products rather than in artisanal ones. “The difference in seizure control is dramatic and is definitely of concern since many people continue to use artisanal CBD”, Said lead author Cohen.
https://www.eurekalert.org/pub_releases/2020-02/aaon-sfa022420.php/
This is the talk delivered by Dr. Helen Cross, President of ILAE (International League Against Epilepsy) on the 15th of October 2020 within the 2020 LACE Congress framework.