Author(s): Wade DT, Collin C, Stott C, Duncombe P
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Abstract OBJECTIVE: To determine the efficacy of Sativex (USAN: nabiximols) in the alleviation of spasticity in people with multiple sclerosis. METHODS: The results from three randomized, placebo-controlled, double-blind parallel group studies were combined for analysis. PATIENTS: 666 patients with multiple sclerosis and spasticity. MEASURES: A 0-100 mm Visual Analogue Scale (VAS, transformed to a 0-10 scale) or a 0-10 Numerical Rating Scale (0-10 NRS) was used to measure spasticity. Patients achieving a > or =30\% improvement from baseline in their spasticity score were defined as 'responders'. Global impression of change (GIC) at the end of treatment was also recorded. RESULTS: The patient populations were similar. The adjusted mean change of the numerical rating scale from baseline in the treated group was -1.30 compared with -0.97 for placebo. Using a linear model, the treatment difference was -0.32 (95\% CI -0.61, -0.04, p = 0.026). A statistically significant greater proportion of treated patients were responders (odds ratio (OR) = 1.62, 95\% CI 1.15, 2.28; p = 0.0073) and treated patients also reported greater improvement: odds ratio 1.67 (95\% CI 1.05, 2.65; p = 0.030). High numbers of subjects experienced at least one adverse event, but most were mild to moderate in severity and all drug-related serious adverse events resolved. CONCLUSION: The meta-analysis demonstrates that nabiximols is well tolerated and reduces spasticity.
This article was published in Mult Scler
and referenced in Journal of Clinical & Experimental Pharmacology