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Article Publish Status: FREE
Abstract Title:

Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity.

Abstract Source:

J Neurol Neurosurg Psychiatry. 2016 May 9. Epub 2016 May 9. PMID: 27160523

Abstract Author(s):

F Patti, S Messina, C Solaro, M P Amato, R Bergamaschi, S Bonavita, R Bruno Bossio, V Brescia Morra, G F Costantino, P Cavalla, D Centonze, G Comi, S Cottone, M Danni, A Francia, A Gajofatto, C Gasperini, A Ghezzi, A Iudice, G Lus, G T Maniscalco, M G Marrosu, M Matta, M Mirabella, E Montanari, C Pozzilli, M Rovaris, E Sessa, D Spitaleri, M Trojano, P Valentino, M Zappia,

Article Affiliation:

F Patti

Abstract:

BACKGROUND: The approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting.

METHODS: We collected data of all patients starting Sativex between January 2014 and February 2015 from the mandatory Italian medicines agency (AIFA) e-registry. Spasticity assessment by the 0-10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months.

RESULTS: A total of 1615 patients were recruited from 30 MS centres across Italy. After one treatment month (trial period), we found 70.5% of patients reaching a≥20% improvement (initial response, IR) and 28.2% who had already reached a ≥30% improvement (clinically relevant response, CRR), with a mean NRS score reduction of 22.6% (from 7.5 to 5.8). After a multivariate analysis, we found an increased probability to reach IR at the first month among patients with primary and secondary progressive MS, (n=1169, OR 1.4 95% CI 1.04 to 1.9, p=0.025) and among patients with>8 NRS score at baseline (OR 1.8 95% CI 1.3-2.4 p<0.001). During the 6 months observation period, 631(39.5%) patients discontinued treatment. The main reasons for discontinuation were lack of effectiveness (n=375, 26.2%) and/or adverse events (n=268, 18.7%).

CONCLUSIONS: Sativex can be a useful and safe option for patients with MS with moderate to severe spasticity resistant to common antispastic drugs.

Study Type : Human Study

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Sayer Ji
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