Thursday, 25 February 2016

Cannabis Discontinuation

Fernández Ó.THC:CBD in Daily Practice: Available Data from UK, Germany and Spain Eur Neurol. 2016;75 Suppl 1:1-3.

BACKGROUND:From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects.
METHODS:A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported.
RESULTS:The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse.
CONCLUSIONS:The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice.
This study looks at the rate of continuing to take cannabis and there is about 30% discountinuation rate. This may be because of lack of efficacy or something unwantef such as side effects or perhaps the method of deliver is unpleasant. Sativex is essentiially cannbis in creme de menthe (mint tasting alcohol).

CoI We are developing alternatives and if you live in the London area and now Liverpool (Walton Centre) you could volunteer.

Ages Eligible for Study:  18 Years to 70 Years
Genders Eligible for Study:  Both
Accepts Healthy Volunteers:  No
Criteria
Inclusion Criteria:
  • Have a confirmed diagnosis of MS
  • Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.
  • Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 m ASHWORTH SCORE
Exclusion Criteria:
  • Acute MS relapse requiring treatment with steroids within 30 days of screening.
  • Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
  • Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
  • Significant renal and hepatic abnormalities
  • Previous history of other significant medical disorders

10 comments:

  1. I have no idea who at GW Pharmaceuticals decided to describe the taste of Sativex as mint / crème de menthe but I would characterise it more as liquid ashtray. However I continue to take it as it helps my spasticity at night

    ReplyDelete
    Replies
    1. In the end helping your spasticity is all that matters.

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    2. I came up with creme de menthe becuase I thought it was mint flavoured but ashtray is a new take happy it helps with the sleep

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    3. I came up with creme de menthe becuase I thought it was mint flavoured but ashtray is a new take happy it helps with the sleep

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  2. They may be more side effects leading to discontinuation of Sativex. I see many who use complaining about the side effects.
    Funny thing is that I know a woman with MS who did not work with any medication and use cannabis every day and says it well, your doctor wants to fit it in some DMT in case ... But it comes to cases count " anecdotes "about MS...

    Crossing my fingers that the clinical trial with VSN16R works out. o//


    VSN16R can help only those who may not have MS, but other neurological diseases that have spasticity as a symptom...

    ReplyDelete
    Replies
    1. Thanks for your support.
      I cant say too much but I believe that if the drug is of use in spasticity in ms then it should affect spasticity in other conditions.We have experimental data shown at a meeting to support that view. Once I can explain how it potentially works then maybe we can see other uses too.
      It depends how rubber the paper is. It has been submitted but whether it gets bounced depends on the reviewers. Fingers crossed.

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  3. The problem with Sativex is that it has cannabis in its name. The perception of cannabis as inherently bad just won't die. Has a head to head with baclofen been done regarding spasticity?

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    Replies
    1. Sativex is logical licensed as an add on so you get baclofen and sativex. If they had weaned people off their drugs for trial it may have been easier to see an effect.
      The new trial does this to my shame it is placebo controlled and people have to be drug naive or be willing to wash out for a couple of weeks.This is hard impossible for some zee

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    2. However the drug holiday may make you realise how sedating current drugs are

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    3. Sativex is logical licensed as an add on so you get baclofen and sativex. If they had weaned people off their drugs for trial it may have been easier to see an effect.
      The new trial does this to my shame it is placebo controlled and people have to be drug naive or be willing to wash out for a couple of weeks.This is hard impossible for some zee

      Delete

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