Tags

Type your tag names separated by a space and hit enter

Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years.
Eur Neurol. 2016; 75 Suppl 1:9-12.EN

Abstract

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.

Authors+Show Affiliations

Department G.F. Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

26901344

Citation

Patti, Francesco. "Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana Del Farmaco Web Registry): Figures After 1.5 Years." European Neurology, vol. 75 Suppl 1, 2016, pp. 9-12.
Patti F. Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years. Eur Neurol. 2016;75 Suppl 1:9-12.
Patti, F. (2016). Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years. European Neurology, 75 Suppl 1, 9-12. https://doi.org/10.1159/000444236
Patti F. Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana Del Farmaco Web Registry): Figures After 1.5 Years. Eur Neurol. 2016;75 Suppl 1:9-12. PubMed PMID: 26901344.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years. A1 - Patti,Francesco, Y1 - 2016/02/23/ PY - 2016/2/23/entrez PY - 2016/2/24/pubmed PY - 2016/10/7/medline SP - 9 EP - 12 JF - European neurology JO - Eur. Neurol. VL - 75 Suppl 1 N2 - 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. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/26901344/Health_Authorities_Data_Collection_of_THC:CBD_Oromucosal_Spray__L'Agenzia_Italiana_del_Farmaco_Web_Registry_:_Figures_after_1_5_Years_ L2 - https://www.karger.com?DOI=10.1159/000444236 DB - PRIME DP - Unbound Medicine ER -