1. Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity
- Author
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Michael Haupts, Lourdes Álvarez-Ossorio, Anna Jonas, Kerstin Witte, and Carlos Vila
- Subjects
Adult ,Male ,Baclofen ,Multiple Sclerosis ,macromolecular substances ,030226 pharmacology & pharmacy ,Clonidine ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,mental disorders ,medicine ,Cannabidiol ,Humans ,Dronabinol ,Spasticity ,Plant Extracts ,business.industry ,organic chemicals ,Multiple sclerosis ,Parasympatholytics ,Middle Aged ,medicine.disease ,digestive system diseases ,Drug Combinations ,surgical procedures, operative ,Neurology ,chemistry ,Tolerability ,Muscle Spasticity ,Anesthesia ,Tizanidine ,Female ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Background: Sativex® (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients. Methods: Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2). Summary: Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID ≥18% improvement vs. baseline) and clinically important difference (CID, ≥30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history. Conclusions: THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history.
- Published
- 2016