Real-life study with pharmaceutical cannabidiol in refractory epilepsy
Pharmaceutical-grade cannabidiol (CBD) is an alternative treatment for patients with drug-resistant epilepsy (DRE). In 2022, the Italian Hospital of Buenos Aires implemented a non-medical change (NMC) of treatment, replacing one commercial pharmaceutical-grade CBD product with another, the latter al...
| Autores principales: | , , , , , , , |
|---|---|
| Formato: | Artículo revista |
| Lenguaje: | Español |
| Publicado: |
Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
2025
|
| Materias: | |
| Acceso en línea: | https://revistas.unc.edu.ar/index.php/med/article/view/45350 |
| Aporte de: |
| id |
I10-R327-article-45350 |
|---|---|
| record_format |
ojs |
| institution |
Universidad Nacional de Córdoba |
| institution_str |
I-10 |
| repository_str |
R-327 |
| container_title_str |
Revista de la Facultad de Ciencias Médicas de Córdoba |
| language |
Español |
| format |
Artículo revista |
| topic |
drug resistant epilepsy cannabidiol treatment outcome drug substitution epilepsia refractaria cannabidiol resultado del tratamiento sustitución de medicamentos epilepsia resistente a medicamentos cannabidiol resultado do tratamento substituição de medicamentos |
| spellingShingle |
drug resistant epilepsy cannabidiol treatment outcome drug substitution epilepsia refractaria cannabidiol resultado del tratamiento sustitución de medicamentos epilepsia resistente a medicamentos cannabidiol resultado do tratamento substituição de medicamentos Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| topic_facet |
drug resistant epilepsy cannabidiol treatment outcome drug substitution epilepsia refractaria cannabidiol resultado del tratamiento sustitución de medicamentos epilepsia resistente a medicamentos cannabidiol resultado do tratamento substituição de medicamentos |
| author |
Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste |
| author_facet |
Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste |
| author_sort |
Di Giuseppe, Luis Angel |
| title |
Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| title_short |
Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| title_full |
Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| title_fullStr |
Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| title_full_unstemmed |
Real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| title_sort |
real-life study with pharmaceutical cannabidiol in refractory epilepsy |
| description |
Pharmaceutical-grade cannabidiol (CBD) is an alternative treatment for patients with drug-resistant epilepsy (DRE). In 2022, the Italian Hospital of Buenos Aires implemented a non-medical change (NMC) of treatment, replacing one commercial pharmaceutical-grade CBD product with another, the latter also being the initial option for new patients. Our objective was to evaluate the clinical outcomes of the commercial product change in this population. Methods: Retrospective cohort of DRE patients who either switched from one commercial pharmaceutical-grade CBD product to another or started treatment with the new product. The clinical response was evaluated by changes in seizure frequency, perception of change with the Patient Global Impression of Change (PGIC) scale, and safety considering discontinuation and/or the presence of adverse effects. Results: Nineteen patients were included, 12 in the change group and 7 in the new start group (7 pediatric and 12 adults). One patient discontinued treatment due to lack of response. Among those who completed follow-up, 8 (44%) reduced seizure frequency, 6 (33%) showed no change, and 4 (22%) increased seizure frequency. According to the PGIC scale, 9 (50%) remained unchanged, 5 (28%) reported barely noticeable changes, and 4 (22%) reported improvement. Adverse events were mild and transient. Conclusion: The new commercial pharmaceutical-grade CBD product is a safe and valid option both for substitution and initial treatment in patients with DRE. During the treatment period, patients perceived stability or improvement according to the PGIC scale. |
| publisher |
Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología |
| publishDate |
2025 |
| url |
https://revistas.unc.edu.ar/index.php/med/article/view/45350 |
| work_keys_str_mv |
AT digiuseppeluisangel reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT appendinojuanignacio reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT garciamariadelcarmen reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT alvarezkarinaelena reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT buelagabriela reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT burgosmarianaandrea reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT posadasmartinezmarialourdes reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT pugamariaceleste reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT digiuseppeluisangel reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT appendinojuanignacio reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT garciamariadelcarmen reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT alvarezkarinaelena reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT buelagabriela reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT burgosmarianaandrea reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT posadasmartinezmarialourdes reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT pugamariaceleste reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT digiuseppeluisangel reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT appendinojuanignacio reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT garciamariadelcarmen reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT alvarezkarinaelena reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT buelagabriela reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT burgosmarianaandrea reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT posadasmartinezmarialourdes reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT pugamariaceleste reallifestudywithpharmaceuticalcannabidiolinrefractoryepilepsy AT digiuseppeluisangel estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT appendinojuanignacio estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT garciamariadelcarmen estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT alvarezkarinaelena estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT buelagabriela estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT burgosmarianaandrea estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT posadasmartinezmarialourdes estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT pugamariaceleste estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT digiuseppeluisangel estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT appendinojuanignacio estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT garciamariadelcarmen estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT alvarezkarinaelena estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT buelagabriela estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT burgosmarianaandrea estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT posadasmartinezmarialourdes estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT pugamariaceleste estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT digiuseppeluisangel estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT appendinojuanignacio estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT garciamariadelcarmen estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT alvarezkarinaelena estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT buelagabriela estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT burgosmarianaandrea estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT posadasmartinezmarialourdes estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT pugamariaceleste estudiodevidarealconcannabidiolfarmaceuticoenepilepsiaresistente AT digiuseppeluisangel estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT appendinojuanignacio estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT garciamariadelcarmen estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT alvarezkarinaelena estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT buelagabriela estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT burgosmarianaandrea estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT posadasmartinezmarialourdes estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT pugamariaceleste estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT digiuseppeluisangel estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT appendinojuanignacio estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT garciamariadelcarmen estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT alvarezkarinaelena estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT buelagabriela estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT burgosmarianaandrea estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT posadasmartinezmarialourdes estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT pugamariaceleste estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT digiuseppeluisangel estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT appendinojuanignacio estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT garciamariadelcarmen estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT alvarezkarinaelena estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT buelagabriela estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT burgosmarianaandrea estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT posadasmartinezmarialourdes estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria AT pugamariaceleste estudodevidarealcomcanabidiolfarmaceuticoemepilepsiarefrataria |
| first_indexed |
2025-05-10T05:10:28Z |
| last_indexed |
2025-05-10T05:10:28Z |
| _version_ |
1831708999884472320 |
| spelling |
I10-R327-article-453502025-04-15T17:01:50Z Real-life study with pharmaceutical cannabidiol in refractory epilepsy Estudio de vida real con cannabidiol farmacéutico en epilepsia resistente Estudo de vida real com canabidiol farmacêutico em epilepsia refratária Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste Di Giuseppe, Luis Angel Appendino, Juan Ignacio García, María del Carmen Alvarez, Karina Elena Buela, Gabriela Burgos, Mariana Andrea Posadas-Martínez, María Lourdes Puga , Maria Celeste drug resistant epilepsy cannabidiol treatment outcome drug substitution epilepsia refractaria cannabidiol resultado del tratamiento sustitución de medicamentos epilepsia resistente a medicamentos cannabidiol resultado do tratamento substituição de medicamentos Pharmaceutical-grade cannabidiol (CBD) is an alternative treatment for patients with drug-resistant epilepsy (DRE). In 2022, the Italian Hospital of Buenos Aires implemented a non-medical change (NMC) of treatment, replacing one commercial pharmaceutical-grade CBD product with another, the latter also being the initial option for new patients. Our objective was to evaluate the clinical outcomes of the commercial product change in this population. Methods: Retrospective cohort of DRE patients who either switched from one commercial pharmaceutical-grade CBD product to another or started treatment with the new product. The clinical response was evaluated by changes in seizure frequency, perception of change with the Patient Global Impression of Change (PGIC) scale, and safety considering discontinuation and/or the presence of adverse effects. Results: Nineteen patients were included, 12 in the change group and 7 in the new start group (7 pediatric and 12 adults). One patient discontinued treatment due to lack of response. Among those who completed follow-up, 8 (44%) reduced seizure frequency, 6 (33%) showed no change, and 4 (22%) increased seizure frequency. According to the PGIC scale, 9 (50%) remained unchanged, 5 (28%) reported barely noticeable changes, and 4 (22%) reported improvement. Adverse events were mild and transient. Conclusion: The new commercial pharmaceutical-grade CBD product is a safe and valid option both for substitution and initial treatment in patients with DRE. During the treatment period, patients perceived stability or improvement according to the PGIC scale. El cannabidiol (CBD) de grado farmacéutico es una alternativa de tratamiento para pacientes con epilepsia resistente a fármacos (ER). En 2022, el Hospital Italiano de Buenos Aires implementó un cambio no médico (CNM) de tratamiento, sustituyendo un producto comercial de CBD farmacéutico por otro, siendo este último también la opción inicial para pacientes nuevos. Nuestro objetivo fue evaluar los resultados clínicos del cambio de producto comercial en esta población. Métodos: Cohorte retrospectiva de pacientes con ER que incluyó pacientes que cambiaron de marca comercial de CBD farmacéutico o iniciaron tratamiento con el nuevo producto. Se evaluó la respuesta clínica como modificación en la frecuencia de crisis, percepción de cambio con la escala de Impresión Global de Cambio (PGIC) y seguridad considerando discontinuación y/o presencia de efectos adversos. Resultados: Se incluyeron 19 pacientes, 12 en el grupo de cambio y 7 de nuevo inicio (7 pediátricos y 12 adultos). Un paciente discontinuó tratamiento por falta de respuesta. De quienes completaron seguimiento, 8 (44%) redujeron la frecuencia de crisis, 6 (33%) no presentaron cambios y 4 (22%) la incrementaron. Según escala PGIC, 9 (50%) se mantuvieron sin cambios, 5 (28%) presentaron cambios apenas perceptibles y 4 (22%) informaron mejoría. Los eventos adversos fueron leves y transitorios. Conclusión: El nuevo producto comercial con CBD de grado farmacéutico es una opción segura y válida tanto en la sustitución como en el tratamiento de inicio en pacientes con ER. Durante el tiempo de tratamiento, los pacientes percibieron estabilidad o mejoría según escala PGIC. O canabidiol (CBD) de grau farmacêutico é uma alternativa de tratamento para pacientes com epilepsia resistente a medicamentos (ERM). Em 2022, o Hospital Italiano de Buenos Aires implementou uma mudança não médica (CNM) de tratamento, substituindo um produto comercial de CBD farmacêutico por outro, sendo este último também a opção inicial para novos pacientes. Nosso objetivo foi avaliar os resultados clínicos da mudança de produto comercial nesta população. Métodos: Coorte retrospectiva de pacientes com ERM que incluíram pacientes que trocaram de marca comercial de CBD farmacêutico ou iniciaram tratamento com o novo produto. A resposta clínica foi avaliada por meio de mudanças na frequência das crises, percepção de mudança com a escala de Impressão Global de Mudança (PGIC) e segurança considerando descontinuação e/ou presença de efeitos adversos. Resultados: Foram incluídos 19 pacientes, 12 no grupo de mudança e 7 no grupo de novo início (7 pediátricos e 12 adultos). Um paciente descontinuou o tratamento devido à falta de resposta. Entre os que completaram o acompanhamento, 8 (44%) reduziram a frequência das crises, 6 (33%) não apresentaram mudanças e 4 (22%) aumentaram a frequência das crises. De acordo com a escala PGIC, 9 (50%) permaneceram inalterados, 5 (28%) relataram mudanças pouco perceptíveis e 4 (22%) relataram melhora. Os eventos adversos foram leves e transitórios. Conclusão: O novo produto comercial com CBD de grau farmacêutico é uma opção segura e válida tanto para substituição quanto para tratamento inicial em pacientes com ERM. Durante o período de tratamento, os pacientes perceberam estabilidade ou melhora de acordo com a escala PGIC. Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2025-03-31 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf text/html https://revistas.unc.edu.ar/index.php/med/article/view/45350 10.31053/1853.0605.v82.n1.45350 Revista de la Facultad de Ciencias Médicas de Córdoba.; Vol. 82 No. 1 (2025); 110-126 Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 82 Núm. 1 (2025); 110-126 Revista da Faculdade de Ciências Médicas de Córdoba; v. 82 n. 1 (2025); 110-126 1853-0605 0014-6722 10.31053/1853.0605.v82.n1 spa https://revistas.unc.edu.ar/index.php/med/article/view/45350/48669 https://revistas.unc.edu.ar/index.php/med/article/view/45350/48784 Derechos de autor 2025 Universidad Nacional de Córdoba https://creativecommons.org/licenses/by-nc/4.0 |