Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

被引：84
|
作者：
Patti, F. [1 ]
Messina, S. [1 ]
Solaro, C. [2 ]
Amato, M. P. [3 ]
Bergamaschi, R. [4 ]
Bonavita, S. [5 ]
Bossio, R. Bruno [6 ,7 ]
Morra, V. Brescia
Costantino, G. F. [8 ]
Cavalla, P. [9 ]
Centonze, D. [10 ,11 ]
Comi, G. [12 ]
Cottone, S. [13 ]
Danni, M. [14 ]
Francia, A. [15 ]
Gajofatto, A. [16 ]
Gasperini, C. [17 ]
Ghezzi, A. [18 ]
Iudice, A. [19 ]
Lus, G. [20 ]
Maniscalco, G. T. [21 ]
Marrosu, M. G. [22 ]
Matta, M. [23 ]
Mirabella, M. [24 ]
Montanari, E. [25 ]
Pozzilli, C. [26 ]
Rovaris, M. [27 ]
Sessa, E. [28 ]
Spitaleri, D. [29 ]
Trojano, M. [30 ]
Valentino, P. [31 ]
Zappia, M. [1 ]
机构：
[1] Univ Catania, Dept Med Surg Sci & Adv Technol GF Ingrassia, Catania, Italy
[2] ASL3 Genova, Dept Head & Neck, Neurol Unit, Genoa, Italy
[3] Univ Florence, Dept NEUROFARBA, Florence, Italy
[4] Neurol Inst C Mondino, Dept Neurol, Pavia, Italy
[5] Univ Naples 2, Clin Neurol 1, Naples, Italy
[6] Prov Hlth Author Cosenza, Neurol Operating Unit, Multiple Sclerosis Ctr, Cosenza, Italy
[7] Univ Naples Federico II, Multiple Sclerosis Ctr, Naples, Italy
[8] Foggia Hosp, Demyelinating Dis Ctr, Foggia, Italy
[9] S Giovanni Battista Molinette Hosp, Multiple Sclerosis Ctr, Turin, Italy
[10] Univ Roma Tor Vergata, Multiple Sclerosis Clin & Res Ctr, Dept Syst Med, Rome, Italy
[11] IRCCS Neuromed, Unit Neurol & Neurorehabil, Pozzilli, IS, Italy
[12] Hosp San Raffaele, Dept Neurol, Milan, Italy
[13] Villa Sofia Cervello Hosp, Neuroimmunol Unit, Palermo, Italy
[14] Ancona Hosp, Neurol Clin, Ancona, Italy
[15] Sapienza Univ, Dept Neurol Psich, Multiple Sclerosis Ctr, Rome, Italy
[16] Univ Verona, Multiple Sclerosis Ctr, Verona, Italy
[17] San Camillo Hosp, Div Neurol, Rome, Italy
[18] St Antonio Abate Hosp, Multiple Sclerosis Ctr, Gallarate, Italy
[19] Univ Hosp Pisa, Multiple Sclerosis Ctr, Pisa, Italy
[20] Univ Naples 2, Multiple Sclerosis Ctr, Naples, Italy
[21] Cardarelli Hosp, Multiple Sclerosis Ctr, Naples, Italy
[22] Univ Cagliari, Dept Med Sci, Cagliari, Italy
[23] San Luigi Gonzaga Hosp, Multiple Sclerosis Ctr CRESM, Orbassano, Italy
[24] Cattolica Univ, Multiple Sclerosis Ctr, Rome, Italy
[25] Vaio Hosp, Multiple Sclerosis Ctr, Fidenza, Italy
[26] S Andrea Hosp, Multiple Sclerosis Ctr, Rome, Italy
[27] IRCCS Don Gnocchi Fdn, Multiple Sclerosis Ctr, Milan, Italy
[28] IRCCS Bonino Pulejo Ctr, Multiple Sclerosis Ctr, Messina, Italy
[29] San G Moscati Hosp, Multiple Sclerosis Ctr, Avellino, Italy
[30] Univ Bari Aldo Moro, Dept Basic Med Sci Neurosci & Sense Organs, Bari, Italy
[31] Magna Graecia Univ Catanzaro, Inst Neurol, Dept Med Sci, Catanzaro, Italy
来源：
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY | 2016年 / 87卷 / 09期
关键词：
DOUBLE-BLIND; SYMPTOMS; MANAGEMENT; SATIVEX(R); MEDICINE;
D O I：
10.1136/jnnp-2015-312591
中图分类号：
R74 [神经病学与精神病学];
学科分类号：
摘要：
Background The approval of 9--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 1month of treatment (trial period), and at 3 and 6months. 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 6months 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.
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页码：944 / 951
页数：8
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