Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis.
To determine the efficacy of Sativex (USAN nabiximols) in the alleviation of spasticity in people with multiple sclerosis. The results from three randomized, placebo-controlled, double-blind parallel group studies were combined for analysis. 666 patients with multiple sclerosis and spasticity. 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. 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. The meta-analysis demonstrates that nabiximols is well tolerated and reduces spasticity.