Author(s): Wade DT, Collin C, Stott C, Duncombe P
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.
Referred From: https://pubmed.ncbi.nlm.nih.gov/20558502/
Author(s): Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL
Author(s): Beard S, Hunn A, Wight J
Author(s): Shakespeare DT, Boggild M, Young C
Author(s): Russo EB
Author(s): Schoedel KA, Chen N, Hilliard A, White L, Stott C, et al.
Author(s): Wade DT, Makela P, Robson P, House H, Bateman C
Author(s): Collin C, Davies P, Mutiboko IK, Ratcliffe S; Sativex Spasticity in MS Study Group
Author(s): Novotna A, Mares J, Ratcliffe S, Novakova I, Zapletalova O, et al
Author(s): Serpell MG, Notcutt W, Collin C
Author(s): Mechoulam R, Parker LA
Author(s): Bovasso GB
Author(s): Degenhardt L, Hall W, Lynskey M
Author(s): Lynskey MT, Glowinski AL, Todorov AA, Bucholz KK, Madden PA, et al.
Author(s): Dougherty DM, Mathias CW, Dawes MA, Furr RM, Charles N, et al.
Author(s): Achiron A, Chapman J, Magalashvili D, Dolev M, Lavie M, et al.
Author(s): Stott CG, White L, Wright S, Wilbraham D, Guy GW
Author(s): Fischer JS, Rudick RA, Cutter GR, Reingold SC
Author(s): Bohannon RW, Smith MB
Author(s): Endler NS, Rutherford A, Denisoff E
Author(s): Rog DJ, Nurmikko TJ, Friede T, Young CA
Author(s): Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P et al.
Author(s): Feinstein A
Author(s): Notcutt WG
Author(s): Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP et al.
Author(s): Nurmikko TJ, Serpell MG, Hoggart B, Toomey PJ, Morlion BJ et al.