Long-Term Effectiveness and Safety of Nabiximols (Tetrahydrocannabinol/Cannabidiol Oromucosal Spray) in Clinical Practice

Flachenecker, Peter; Henze, Thomas; Zettl, Uwe K.

doi:10.1159/000360285

Cited by 50 publications

(48 citation statements)

References 18 publications

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“…None of the 3 deaths that occurred was considered by the treating physician to be related to THC:CBD spray. The tolerability profile of THC:CBD spray in Spanish patients aligns with that reported in the observational MObility improVEment 2 (MOVE 2) study from Germany in which THC:CBD spray was prescribed to patients with treatment-resistant MS spasticity (n=300) according to approved labelling [19,20].…”

Section: Polyuriasupporting

confidence: 69%

Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with Spasticity

Guevara¹

2015

Clin Exp Pharmacol

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Section: Polyuriasupporting

confidence: 69%

Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with Spasticity

Guevara¹

2015

Clin Exp Pharmacol

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“…This latter aspect remains the major challenge for the future and it may be facilitated by the recent approval of the first cannabinoidbased medicines [e.g., Sativex (GWPharma), Epidiolex (GWPharma)] available for clinical use. These formulations, and additional combination of phytocannabinoids, present 2 important advantages: 2) its safety demonstrated in previous studies [169], despite the fact that manipulation of the endocannabinoid system may be harmful in certain circumstances [1], a fact deserving additional investigation; and 2) its broad-range profile that appears to be adequate for diseases in which different cytotoxic mechanisms cooperate to damage specific neuronal subpopulations. Therefore, it is expected and desirable that the issue recruits an important amount of clinical research in the future, which will allow for the promising expectation generated around the progress of these molecules from the present preclinical evidence to a real clinical exploitation.…”

Section: Concluding Remarks and Future Perspectivesmentioning

confidence: 99%

Cannabinoids in Neurodegenerative Disorders and Stroke/Brain Trauma: From Preclinical Models to Clinical Applications

2015

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Cannabinoids form a singular family of plantderived compounds (phytocannabinoids), endogenous signaling lipids (endocannabinoids), and synthetic derivatives with multiple biological effects and therapeutic applications in the central and peripheral nervous systems. One of these properties is the regulation of neuronal homeostasis and survival, which is the result of the combination of a myriad of effects addressed to preserve, rescue, repair, and/or replace neurons, and also glial cells against multiple insults that may potentially damage these cells. These effects are facilitated by the location of specific targets for the action of these compounds (e.g., cannabinoid type 1 and 2 receptors, endocannabinoid inactivating enzymes, and nonendocannabinoid targets) in key cellular substrates (e.g., neurons, glial cells, and neural progenitor cells). This potential is promising for acute and chronic neurodegenerative pathological conditions. In this review, we will collect all experimental evidence, mainly obtained at the preclinical level, supporting that different cannabinoid compounds may be neuroprotective in adult and neonatal ischemia, brain trauma, Alzheimer's disease, Parkinson's disease, Huntington's chorea, and amyotrophic lateral sclerosis. This increasing experimental evidence demands a prompt clinical validation of cannabinoid-based medicines for the treatment of all these disorders, which, at present, lack efficacious treatments for delaying/arresting disease progression, despite the fact that the few clinical trials conducted so far with these medicines have failed to demonstrate beneficial effects.

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“…25 Given that this improvement occurred without a corresponding significant change in mood, the authors suggest that patients have felt a benefit from intrinsic reduction in pain, sleep improvement, or both. 25 A recent review, including four randomized controlled trials, 21,29,42,43 two extension studies, 27,44 and a prospective noninterventional study in clinical practice with a long-term extension phase, 45,46 has shown that approximately 40% of patients with moderate-tosevere spasticity resistant to the current available oral antispasticity agents reached relevant symptomatic relief with Sativex oromucosal spray that was accompanied by improvement of spasticity-associated symptoms or functional impairment, including sleep quality. 41 In particular, in one study, 44 the proportion of patients who rated their sleep quality as "bad" or "very bad" decreased from 13% to 11%, whereas those who rated it as "good" or "very good" increased from 50% to 59%; in another investigation, 21 61% of Sativex responders also achieved a ⩾30% improvement on the sleep quality Numerical Rating Scale (NRS); in the prospective observational MOVE 2 study, 45 the addon therapy with Sativex produced a significant 24.3% decrease from baseline to week 4 in the mean sleep disturbances NRS score, and among patients who progressed to the 12-month extension study, 46 there was a highly significant 37.2% reduction from baseline in the mean sleep disruption NRS score.…”

Section: Cannabis-based Extractsmentioning

confidence: 99%

The impact of drugs for multiple sclerosis on sleep

et al. 2016

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Abstract:Although there is a growing literature on the presence of sleep disorders in multiple sclerosis (MS), few studies have specifically addressed the impact of drugs on sleep of these patients. Moreover, even when sleep is considered, quantitative assessment by standardized questionnaires or polysomnography is lacking. The studies that have been done highlight that interferon-beta and some symptomatic medications may affect sleep, thus contributing to fatigue, depression, and poor quality of life; conversely, natalizumab and cannabinoids may improve sleep. Common limitations of the literature reviewed here are small sample size, selection bias, and often a lack of objective outcome measures. Clinicians need to remember to ask about sleep in all MS patients and intervene when appropriate. A systematic approach that takes sleep into account is recommended to enhance recognition and appropriate management of sleep disruption, including disorders related to medication. Consideration of the impact on sleep should also be part of the design of trials of new therapies. Tables 1 and 2, both disease-modifying drugs and common symptomatic medications for MS may interfere with sleep. 33 Keywords MethylprednisoloneAs known, insomnia and other sleep changes, such as decreased REM sleep, are common side effects of steroid treatment, even after only a few days of administration. 34 A randomized, placebo-controlled trial of oral methylprednisolone given in pulses every 4 weeks as an add-on therapy to IFN-β-1a for the treatment of relapsing-remitting MS was carried out. 6 The authors found that steroid intake led to a significant reduction in relapse rate; however, insomnia was one of the most frequent adverse event recorded (~25% of patients). 6 As in the general population, the clinician must consider this co-morbid cause of insomnia and encourage lifestyle changes (such as proper sleep hygiene), cognitive behavioral therapy (CBT), and pharmacological intervention if needed. 35 A very recent prospective multicenter observational study evaluated through self-report questionnaires the frequency, severity, and impact on activities of daily living of adverse effects of high-dose intravenous methylprednisolone in relapsing-remitting MS patients with a relapse. The authors observed that sleep disturbance (not better specified) was among the most common adverse events experienced by the patients (44% of 59), especially in those with high disease impact or high disability. 8Nevertheless, although most clinicians warn patients about the steroid-related effects on sleep, an actigraphy study evaluating the short-term tolerance of 5-day regimen of intravenous methylprednisolone demonstrated high sleep efficiency, which is discrepant with the complaints reported by the patients. The authors conclude that sleep efficiency was not disturbed by methylprednisolone in patients, whether used for a clinically isolated syndrome (CIS), MS relapse, or sub-acute disease progression. 7 IFN-βSince its introduction as an established therapy for re...

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Long-Term Effectiveness and Safety of Nabiximols (Tetrahydrocannabinol/Cannabidiol Oromucosal Spray) in Clinical Practice

Cited by 50 publications

References 18 publications

Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with Spasticity

Observational Safety Study of THC: CBD Oromucosal Spray (Sativex) in Multiple Sclerosis Patients with Spasticity

Cannabinoids in Neurodegenerative Disorders and Stroke/Brain Trauma: From Preclinical Models to Clinical Applications

The impact of drugs for multiple sclerosis on sleep

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