Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity
نویسندگان
چکیده
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.
منابع مشابه
Advances in the management of multiple sclerosis spasticity: recent clinical trials.
BACKGROUND Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity...
متن کاملTHC:CBD in Daily Practice: Available Data from UK, Germany and Spain.
BACKGROUND From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. METHODS A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. RESULTS The m...
متن کاملAdvances in the management of multiple sclerosis spasticity: multiple sclerosis spasticity nervous pathways.
BACKGROUND Spasticity arises from hyperexcitability of the neural stretch reflex arc secondary to injury of the corticospinal tract. In response to injury, the density of glutamatergic inputs from afferent 1A fibers to motor neurons increases dramatically and adaptive changes occur in the morphology of microglia cells in the spinal cord. SUMMARY Involvement of the endocannabinoid system in pa...
متن کاملAdvances in the Management of Multiple Sclerosis Spasticity: Recent Clinical Trials
Background: Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex ® ) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispastic...
متن کاملAdvances in the Management of Multiple Sclerosis Spasticity: Recent Clinical Trials
Background: Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex ® ) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispastic...
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عنوان ژورنال:
دوره 87 شماره
صفحات -
تاریخ انتشار 2016