Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years
Autor: | Francesco Patti |
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Rok vydání: | 2016 |
Předmět: |
Adult
Male medicine.medical_specialty Multiple Sclerosis AIFA registry Effectiveness Multiple sclerosis spasticity THC:CBD oromucosal spray Tolerability Medical Marijuana 03 medical and health sciences 0302 clinical medicine Internal medicine Medicine Cannabidiol Humans 030212 general & internal medicine Spasticity Dronabinol Prospective Studies Registries Medical prescription Adverse effect Prospective cohort study Expanded Disability Status Scale business.industry Plant Extracts Data Collection Middle Aged Clinical trial Drug Combinations Treatment Outcome Neurology Italy Muscle Spasticity Physical therapy Observational study Female Neurology (clinical) medicine.symptom Oral Sprays business 030217 neurology & neurosurgery |
Zdroj: | European neurology. 75 |
ISSN: | 1421-9913 |
Popis: | Background: In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner. Methods: AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 ± 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 ± 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS). Results: After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (≥20% NRS) to qualify for continued treatment. After 6 months, clinically meaningful ≥30% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified. Conclusion: The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom. |
Databáze: | OpenAIRE |
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