Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity
| Autor: | Patti F., Messina S., Solaro C., Amato M. P., Bergamaschi R., Bonavita S., Bruno Bossio R., Brescia Morra V., Costantino G. F., Cavalla P., Centonze D., Comi G., Cottone S., Danni M., Francia A., Gajofatto A., Gasperini C., Ghezzi A., Iudice A., Lus G., Maniscalco G. T., Marrosu M. G., Matta M., Mirabella M., Montanari E., Pozzilli C., Rovaris M., Sessa E., Spitaleri D., Trojano M., Valentino P., Zappia M., Benedetti MD, Bertolotto A, Berra E, Bianco A, Buttari F, Cerqua R, Florio C, Fuiani A, Guareschi A, Ippolito D, Nuara A, Palmieri V, Paolicelli D, Petrucci L, Pontecorvo S, Saccà Francesco, Salamone G, Signoriello E, Spinicci G, Russo M, Tavazzi E Trabucco E, Trotta M, Zaffaroni M. |
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| Přispěvatelé: | Patti, F, Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, Simona, Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, Giacomo, Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Patti, F., Bonavita, S., Lus, G., Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Saccà, Francesco, Salamone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E Trabucco E, Trotta, M, Zaffaroni, M., Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bossio, Rb, Morra, Vb, Costantino, Gf, Cavalla, P, Centonze, D, Comi, Giancarlo, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Multivariate analysis
assessment Administration Oral patients 0302 clinical medicine Drug Combination Multiple Sclerosi 9- δ -tetrahydocannabinol cannabidiol Sativex multiple sclerosis treatment-resistant spasticity Italy Cannabidiol Medicine Dronabinol 030212 general & internal medicine cannabinoid Drug Combinations Muscle Spasticity Psychiatry and Mental Health Humans Multiple Sclerosis Plant Extracts Safety Surgery Neurology (clinical) Administration Settore MED/26 - Neurologia medicine.symptom Human medicine.drug Oral medicine.medical_specialty Nabiximols Plant Extract 03 medical and health sciences Arts and Humanities (miscellaneous) Rating scale Internal medicine Spasticity Adverse effect multiple sclerosis cannabinoid business.industry Multiple sclerosis medicine.disease Physical therapy Observational study business 030217 neurology & neurosurgery |
| Zdroj: | Journal of Neurology, Neurosurgery, and Psychiatry |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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