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Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.
Eur Neurol 2016; 75(5-6):236-43EN

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.

Authors+Show Affiliations

Department of Neurology, Augusta Hospital Anholt, Isselburg-Anholt, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27160412

Citation

Haupts, Michael, et al. "Influence of Previous Failed Antispasticity Therapy On the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity." European Neurology, vol. 75, no. 5-6, 2016, pp. 236-43.
Haupts M, Vila C, Jonas A, et al. Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity. Eur Neurol. 2016;75(5-6):236-43.
Haupts, M., Vila, C., Jonas, A., Witte, K., & Álvarez-Ossorio, L. (2016). Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity. European Neurology, 75(5-6), pp. 236-43. doi:10.1159/000445943.
Haupts M, et al. Influence of Previous Failed Antispasticity Therapy On the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity. Eur Neurol. 2016;75(5-6):236-43. PubMed PMID: 27160412.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity. AU - Haupts,Michael, AU - Vila,Carlos, AU - Jonas,Anna, AU - Witte,Kerstin, AU - Álvarez-Ossorio,Lourdes, Y1 - 2016/05/10/ PY - 2016/02/25/received PY - 2016/04/01/accepted PY - 2016/5/11/entrez PY - 2016/5/11/pubmed PY - 2017/9/28/medline SP - 236 EP - 43 JF - European neurology JO - Eur. Neurol. VL - 75 IS - 5-6 N2 - 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. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/27160412/Influence_of_Previous_Failed_Antispasticity_Therapy_on_the_Efficacy_and_Tolerability_of_THC:CBD_Oromucosal_Spray_for_Multiple_Sclerosis_Spasticity_ L2 - https://www.karger.com?DOI=10.1159/000445943 DB - PRIME DP - Unbound Medicine ER -