Posts Tagged CBD

[Abstract + References] Efficacy and Safety of Cannabidiol in Epilepsy: A Systematic Review and Meta-Analysis

Abstract

Background

Approximately one-third of patients with epilepsy presents seizures despite adequate treatment. Hence, there is the need to search for new therapeutic options. Cannabidiol (CBD) is a major chemical component of the resin of Cannabis sativa plant, most commonly known as marijuana. The anti-seizure properties of CBD do not relate to the direct action on cannabinoid receptors, but are mediated by a multitude of mechanisms that include the agonist and antagonist effects on ionic channels, neurotransmitter transporters, and multiple 7-transmembrane receptors. In contrast to tetra-hydrocannabinol, CBD lacks psychoactive properties, does not produce euphoric or intrusive side effects, and is largely devoid of abuse liability.

Objective

The aim of the study was to estimate the efficacy and safety of CBD as adjunctive treatment in patients with epilepsy using meta-analytical techniques.

Methods

Randomized, placebo-controlled, single- or double-blinded add-on trials of oral CBD in patients with uncontrolled epilepsy were identified. Main outcomes included the percentage change and the proportion of patients with ≥ 50% reduction in monthly seizure frequency during the treatment period and the incidence of treatment withdrawal and adverse events (AEs).

Results

Four trials involving 550 patients with Lennox–Gastaut syndrome (LGS) and Dravet syndrome (DS) were included. The pooled average difference in change in seizure frequency during the treatment period resulted 19.5 [95% confidence interval (CI) 8.1–31.0; p = 0.001] percentage points between the CBD 10 mg and placebo groups and 19.9 (95% CI 11.8–28.1; p < 0.001) percentage points between the CBD 20 mg and placebo arms, in favor of CBD. The reduction in all-types seizure frequency by at least 50% occurred in 37.2% of the patients in the CBD 20 mg group and 21.2% of the placebo-treated participants [risk ratio (RR) 1.76, 95% CI 1.07–2.88; p = 0.025]. Across the trials, drug withdrawal for any reason occurred in 11.1% and 2.6% of participants receiving CBD and placebo, respectively (RR 3.54, 95% CI 1.55–8.12; p = 0.003) [Chi squared = 2.53, degrees of freedom (df) = 3, p = 0.506; I2 = 0.0%]. The RRs to discontinue treatment were 1.45 (95% CI 0.28–7.41; p = 0.657) and 4.20 (95% CI 1.82–9.68; p = 0.001) for CBD at the doses of 10 and 20 mg/kg/day, respectively, in comparison to placebo. Treatment was discontinued due to AEs in 8.9% and 1.8% of patients in the active and control arms, respectively (RR 5.59, 95% CI 1.87–16.73; p = 0.002). The corresponding RRs for CBD at the doses of 10 and 20 mg/kg/day were 1.66 (95% CI 0.22–12.86; p = 0.626) and 6.89 (95% CI 2.28–20.80; p = 0.001). AEs occurred in 87.9% and 72.2% of patients treated with CBD and placebo (RR 1.22, 95% CI 1.11–1.33; p < 0.001). AEs significantly associated with CBD were somnolence, decreased appetite, diarrhea, and increased serum aminotransferases.

Conclusions

Adjunctive CBD in patients with LGS or DS experiencing seizures uncontrolled by concomitant anti-epileptic treatment regimens is associated with a greater reduction in seizure frequency and a higher rate of AEs than placebo.

References

  1. 1.
    Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the “common” neurologic disorders? Neurology. 2007;68:326–37.CrossRefGoogle Scholar
  2. 2.
    Cagnetti C, Lattanzi S, Foschi N, Provinciali L, Silvestrini M. Seizure course during pregnancy in catamenial epilepsy. Neurology. 2014;83:339–44.CrossRefGoogle Scholar
  3. 3.
    Cockerell OC, Johnson AL, Sander JW, Hart YM, Shorvon SD. Remission of epilepsy: results from the national general practice study of epilepsy. Lancet. 1995;346:140–4.CrossRefGoogle Scholar
  4. 4.
    Lattanzi S, Zaccara G, Giovannelli F, Grillo E, Nardone R, Silvestrini M, et al. Antiepileptic mono-therapy in newly diagnosed focal epilepsy. A network meta-analysis. Acta Neurol Scand.  https://doi.org/10.1111/ane.13025 (Epub 2018 Sep 8).
  5. 5.
    Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Lacosamide monotherapy for partial onset seizures. Seizure. 2015;27:71–4.CrossRefGoogle Scholar
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    Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314–9.CrossRefGoogle Scholar
  7. 7.
    Lattanzi S, Cagnetti C, Foschi N, Lorusso A, Provinciali L, Silvestrini M. Eslicarbazepine acetate as adjunctive treatment in partial-onset epilepsy. Acta Neurol Scand. 2018;137:29–32.CrossRefGoogle Scholar
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    Lattanzi S, Cagnetti C, Matricardi S, Silvestrini M. Palliative non-resective surgery for drug-resistant epilepsy. Brain Dev. 2018;40:512–3.CrossRefGoogle Scholar
  9. 9.
    Devinsky O, Cilio MR, Cross H, Fernandez-Ruiz J, French J, Hill C, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014;55:791–802.CrossRefGoogle Scholar
  10. 10.
    Ibeas Bih C, Chen T, Nunn AV, Bazelot M, Dallas M, Whalley BJ. Molecular targets of cannabidiol in neurological disorders. Neurotherapeutics. 2015;12:699–730.CrossRefGoogle Scholar
  11. 11.
    GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences announce FDA approval of EPIDIOLEX® (cannabidiol) oral solution—the first plant-derived cannabinoid prescription medicine. https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-biosciences-announce-fda. Accessed Sep 2018.
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    Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.CrossRefGoogle Scholar
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    Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016;15:270–8.CrossRefGoogle Scholar
  14. 14.
    Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011]. Higgins JPT, Green S, editors. The Cochrane Collaboration, 2011. http://handbook-5-1.cochrane.org/. Accessed Jun 2018.
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    Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60.CrossRefGoogle Scholar
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    Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58.CrossRefGoogle Scholar
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    Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Brivaracetam add-on for refractory focal epilepsy: a systematic review and meta-analysis. Neurology. 2016;86:1344–52.CrossRefGoogle Scholar
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    Lattanzi S, Brigo F, Grillo E, Cagnetti C, Verrotti A, Zaccara G, et al. Adjunctive eslicarbazepine acetate in pediatric patients with focal epilepsy: a systematic review and meta-analysis. CNS Drugs. 2018;32:189–96.CrossRefGoogle Scholar
  19. 19.
    Lattanzi S, Grillo E, Brigo F, Silvestrini M. Efficacy and safety of perampanel in Parkinson’s disease. A systematic review with meta-analysis. J Neurol. 2018;265:733–40.CrossRefGoogle Scholar
  20. 20.
    Lattanzi S, Cagnetti C, Danni M, Provinciali L, Silvestrini M. Oral and intravenous steroids for multiple sclerosis relapse: a systematic review and meta-analysis. J Neurol. 2017;264:1697–704.CrossRefGoogle Scholar
  21. 21.
    Lattanzi S, Brigo F, Cagnetti C, Di Napoli M, Silvestrini M. Patent foramen ovale and cryptogenic stroke or transient ischemic attack: to close or not to close? A systematic review and meta-analysis. Cerebrovasc Dis. 2018;45:193–203.CrossRefGoogle Scholar
  22. 22.
    Lattanzi S, Brigo F, Di Napoli M, Cagnetti C, Corradetti T, Silvestrini M. Endovascular treatment of symptomatic vertebral artery stenosis: a systematic review and meta-analysis. J Neurol Sci. 2018;391:48–53.CrossRefGoogle Scholar
  23. 23.
    Devinsky O, Patel AD, Thiele EA, Wong MH, Appleton R, Harden CL, et al.; GWPCARE1 Part A Study Group. Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology. 2018;90:e1204–11.CrossRefGoogle Scholar
  24. 24.
    Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, et al.; Cannabidiol in Dravet Syndrome Study Group. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med. 2017;376:2011–2020.CrossRefGoogle Scholar
  25. 25.
    Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, et al.; GWPCARE3 Study Group. Effect of cannabidiol on drop seizures in the Lennox–Gastaut syndrome. N Engl J Med. 2018;378:1888-1897.CrossRefGoogle Scholar
  26. 26.
    Thiele EA, Marsh ED, French JA, Mazurkiewicz-Beldzinska M, Benbadis SR, Joshi C, et al.; GWPCARE4 Study Group. Cannabidiol in patients with seizures associated with Lennox–Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391:1085–96.Google Scholar
  27. 27.
    Lattanzi S, Brigo F, Cagnetti C, Trinka E, Silvestrini M. Efficacy and safety of adjunctive cannabidiol in patients with Lennox–Gastaut syndrome: a systematic review and meta-analysis. CNS Drugs.  https://doi.org/10.1007/s40263-018-0558-9 (Epub 2018 Aug 21).CrossRefGoogle Scholar
  28. 28.
    Morrison G, Sardu M, Rasmussen C, Sommerville K, Roberts C, Blakey GE. Exposure-response analysis of cannabidiol oral solution for the treatment of Lennox–Gastaut syndrome [abstract no. 2.281]. The American Epilepsy Society Annual Meeting; 1–5 Dec 2017; Washington, DC. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/344717. Accessed Jul 2018.
  29. 29.
    FDA. Cannabidiol oral solution. Full prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf. Accessed Jul 2018.
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    Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox–Gastaut syndrome. Neurology. 2011;77:1473–81.CrossRefGoogle Scholar
  31. 31.
    Glauser T, Kluger G, Sachdeo R, Krauss G, Perdomo C, Arroyo S. Rufinamide for generalized seizures associated with Lennox–Gastaut syndrome. Neurology. 2008;70:1950–8.CrossRefGoogle Scholar
  32. 32.
    Chiron C, Tonnelier S, Rey E, Brunet ML, Tran A, d’Athis P, et al. Stiripentol in childhood partial epilepsy: randomized placebo-controlled trial with enrichment and withdrawal design. J Child Neurol. 2006;21:496–502.CrossRefGoogle Scholar
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[Abstract + References] Efficacy and Safety of Cannabidiol in Epilepsy: A Systematic Review and Meta-Analysis

Abstract

Background

Approximately one-third of patients with epilepsy presents seizures despite adequate treatment. Hence, there is the need to search for new therapeutic options. Cannabidiol (CBD) is a major chemical component of the resin of Cannabis sativa plant, most commonly known as marijuana. The anti-seizure properties of CBD do not relate to the direct action on cannabinoid receptors, but are mediated by a multitude of mechanisms that include the agonist and antagonist effects on ionic channels, neurotransmitter transporters, and multiple 7-transmembrane receptors. In contrast to tetra-hydrocannabinol, CBD lacks psychoactive properties, does not produce euphoric or intrusive side effects, and is largely devoid of abuse liability.

Objective

The aim of the study was to estimate the efficacy and safety of CBD as adjunctive treatment in patients with epilepsy using meta-analytical techniques.

Methods

Randomized, placebo-controlled, single- or double-blinded add-on trials of oral CBD in patients with uncontrolled epilepsy were identified. Main outcomes included the percentage change and the proportion of patients with ≥ 50% reduction in monthly seizure frequency during the treatment period and the incidence of treatment withdrawal and adverse events (AEs).

Results

Four trials involving 550 patients with Lennox–Gastaut syndrome (LGS) and Dravet syndrome (DS) were included. The pooled average difference in change in seizure frequency during the treatment period resulted 19.5 [95% confidence interval (CI) 8.1–31.0; p = 0.001] percentage points between the CBD 10 mg and placebo groups and 19.9 (95% CI 11.8–28.1; p < 0.001) percentage points between the CBD 20 mg and placebo arms, in favor of CBD. The reduction in all-types seizure frequency by at least 50% occurred in 37.2% of the patients in the CBD 20 mg group and 21.2% of the placebo-treated participants [risk ratio (RR) 1.76, 95% CI 1.07–2.88; p = 0.025]. Across the trials, drug withdrawal for any reason occurred in 11.1% and 2.6% of participants receiving CBD and placebo, respectively (RR 3.54, 95% CI 1.55–8.12; p = 0.003) [Chi squared = 2.53, degrees of freedom (df) = 3, p = 0.506; I2 = 0.0%]. The RRs to discontinue treatment were 1.45 (95% CI 0.28–7.41; p = 0.657) and 4.20 (95% CI 1.82–9.68; p = 0.001) for CBD at the doses of 10 and 20 mg/kg/day, respectively, in comparison to placebo. Treatment was discontinued due to AEs in 8.9% and 1.8% of patients in the active and control arms, respectively (RR 5.59, 95% CI 1.87–16.73; p = 0.002). The corresponding RRs for CBD at the doses of 10 and 20 mg/kg/day were 1.66 (95% CI 0.22–12.86; p = 0.626) and 6.89 (95% CI 2.28–20.80; p = 0.001). AEs occurred in 87.9% and 72.2% of patients treated with CBD and placebo (RR 1.22, 95% CI 1.11–1.33; p < 0.001). AEs significantly associated with CBD were somnolence, decreased appetite, diarrhea, and increased serum aminotransferases.

Conclusions

Adjunctive CBD in patients with LGS or DS experiencing seizures uncontrolled by concomitant anti-epileptic treatment regimens is associated with a greater reduction in seizure frequency and a higher rate of AEs than placebo.

Supplementary material

40265_2018_992_MOESM1_ESM.doc (31 kb)

Supplementary material 1 (DOC 31 kb)

References

  1. 1.
    Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the “common” neurologic disorders? Neurology. 2007;68:326–37.CrossRefGoogle Scholar
  2. 2.
    Cagnetti C, Lattanzi S, Foschi N, Provinciali L, Silvestrini M. Seizure course during pregnancy in catamenial epilepsy. Neurology. 2014;83:339–44.CrossRefGoogle Scholar
  3. 3.
    Cockerell OC, Johnson AL, Sander JW, Hart YM, Shorvon SD. Remission of epilepsy: results from the national general practice study of epilepsy. Lancet. 1995;346:140–4.CrossRefGoogle Scholar
  4. 4.
    Lattanzi S, Zaccara G, Giovannelli F, Grillo E, Nardone R, Silvestrini M, et al. Antiepileptic mono-therapy in newly diagnosed focal epilepsy. A network meta-analysis. Acta Neurol Scand.  https://doi.org/10.1111/ane.13025 (Epub 2018 Sep 8).
  5. 5.
    Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Lacosamide monotherapy for partial onset seizures. Seizure. 2015;27:71–4.CrossRefGoogle Scholar
  6. 6.
    Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314–9.CrossRefGoogle Scholar
  7. 7.
    Lattanzi S, Cagnetti C, Foschi N, Lorusso A, Provinciali L, Silvestrini M. Eslicarbazepine acetate as adjunctive treatment in partial-onset epilepsy. Acta Neurol Scand. 2018;137:29–32.CrossRefGoogle Scholar
  8. 8.
    Lattanzi S, Cagnetti C, Matricardi S, Silvestrini M. Palliative non-resective surgery for drug-resistant epilepsy. Brain Dev. 2018;40:512–3.CrossRefGoogle Scholar
  9. 9.
    Devinsky O, Cilio MR, Cross H, Fernandez-Ruiz J, French J, Hill C, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014;55:791–802.CrossRefGoogle Scholar
  10. 10.
    Ibeas Bih C, Chen T, Nunn AV, Bazelot M, Dallas M, Whalley BJ. Molecular targets of cannabidiol in neurological disorders. Neurotherapeutics. 2015;12:699–730.CrossRefGoogle Scholar
  11. 11.
    GW Pharmaceuticals plc and its U.S. subsidiary Greenwich Biosciences announce FDA approval of EPIDIOLEX® (cannabidiol) oral solution—the first plant-derived cannabinoid prescription medicine. https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-biosciences-announce-fda. Accessed Sep 2018.
  12. 12.
    Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.CrossRefGoogle Scholar
  13. 13.
    Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016;15:270–8.CrossRefGoogle Scholar
  14. 14.
    Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011]. Higgins JPT, Green S, editors. The Cochrane Collaboration, 2011. http://handbook-5-1.cochrane.org/. Accessed Jun 2018.
  15. 15.
    Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60.CrossRefGoogle Scholar
  16. 16.
    Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58.CrossRefGoogle Scholar
  17. 17.
    Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Brivaracetam add-on for refractory focal epilepsy: a systematic review and meta-analysis. Neurology. 2016;86:1344–52.CrossRefGoogle Scholar
  18. 18.
    Lattanzi S, Brigo F, Grillo E, Cagnetti C, Verrotti A, Zaccara G, et al. Adjunctive eslicarbazepine acetate in pediatric patients with focal epilepsy: a systematic review and meta-analysis. CNS Drugs. 2018;32:189–96.CrossRefGoogle Scholar
  19. 19.
    Lattanzi S, Grillo E, Brigo F, Silvestrini M. Efficacy and safety of perampanel in Parkinson’s disease. A systematic review with meta-analysis. J Neurol. 2018;265:733–40.CrossRefGoogle Scholar
  20. 20.
    Lattanzi S, Cagnetti C, Danni M, Provinciali L, Silvestrini M. Oral and intravenous steroids for multiple sclerosis relapse: a systematic review and meta-analysis. J Neurol. 2017;264:1697–704.CrossRefGoogle Scholar
  21. 21.
    Lattanzi S, Brigo F, Cagnetti C, Di Napoli M, Silvestrini M. Patent foramen ovale and cryptogenic stroke or transient ischemic attack: to close or not to close? A systematic review and meta-analysis. Cerebrovasc Dis. 2018;45:193–203.CrossRefGoogle Scholar
  22. 22.
    Lattanzi S, Brigo F, Di Napoli M, Cagnetti C, Corradetti T, Silvestrini M. Endovascular treatment of symptomatic vertebral artery stenosis: a systematic review and meta-analysis. J Neurol Sci. 2018;391:48–53.CrossRefGoogle Scholar
  23. 23.
    Devinsky O, Patel AD, Thiele EA, Wong MH, Appleton R, Harden CL, et al.; GWPCARE1 Part A Study Group. Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology. 2018;90:e1204–11.CrossRefGoogle Scholar
  24. 24.
    Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, et al.; Cannabidiol in Dravet Syndrome Study Group. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med. 2017;376:2011–2020.CrossRefGoogle Scholar
  25. 25.
    Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, et al.; GWPCARE3 Study Group. Effect of cannabidiol on drop seizures in the Lennox–Gastaut syndrome. N Engl J Med. 2018;378:1888-1897.CrossRefGoogle Scholar
  26. 26.
    Thiele EA, Marsh ED, French JA, Mazurkiewicz-Beldzinska M, Benbadis SR, Joshi C, et al.; GWPCARE4 Study Group. Cannabidiol in patients with seizures associated with Lennox–Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391:1085–96.Google Scholar
  27. 27.
    Lattanzi S, Brigo F, Cagnetti C, Trinka E, Silvestrini M. Efficacy and safety of adjunctive cannabidiol in patients with Lennox–Gastaut syndrome: a systematic review and meta-analysis. CNS Drugs.  https://doi.org/10.1007/s40263-018-0558-9 (Epub 2018 Aug 21).CrossRefGoogle Scholar
  28. 28.
    Morrison G, Sardu M, Rasmussen C, Sommerville K, Roberts C, Blakey GE. Exposure-response analysis of cannabidiol oral solution for the treatment of Lennox–Gastaut syndrome [abstract no. 2.281]. The American Epilepsy Society Annual Meeting; 1–5 Dec 2017; Washington, DC. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/344717. Accessed Jul 2018.
  29. 29.
    FDA. Cannabidiol oral solution. Full prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf. Accessed Jul 2018.
  30. 30.
    Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox–Gastaut syndrome. Neurology. 2011;77:1473–81.CrossRefGoogle Scholar
  31. 31.
    Glauser T, Kluger G, Sachdeo R, Krauss G, Perdomo C, Arroyo S. Rufinamide for generalized seizures associated with Lennox–Gastaut syndrome. Neurology. 2008;70:1950–8.CrossRefGoogle Scholar
  32. 32.
    Chiron C, Tonnelier S, Rey E, Brunet ML, Tran A, d’Athis P, et al. Stiripentol in childhood partial epilepsy: randomized placebo-controlled trial with enrichment and withdrawal design. J Child Neurol. 2006;21:496–502.CrossRefGoogle Scholar
  33. 33.
    FDA briefing document. Peripheral and central nervous system drugs. Advisory Committee Meeting. April 19, 2018. NDA 210365. Cannabidiol. https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/peripheralandcentralnervoussystemdrugsadvisorycommittee/ucm604736.pdf. Accessed Jul 2018.
  34. 34.
    US Department of Health and Human Services. Guidance for industry. Drug-induced liver injury: premarketing clinical evaluation. 2009. https://www.fda.gov/downloads/Guidances/UCM174090.pdf. Accessed Jul 2018.
  35. 35.
    Geffrey AL, Pollack SF, Bruno PL, Thiele EA. Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy. Epilepsia. 2015;56:1246–51.CrossRefGoogle Scholar
  36. 36.
    Thiele EA, Devinsky O, Checketts D, Knappertz V. Cannabidiol (CBD) treatment responders analysis in patients with Lennox–Gastaut syndrome (LGS) on and off clobazam (CLB) [abstract no. 1.436]. The American Epilepsy Society Annual Meeting; 1–5 Dec 2017; Washington, DC. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/381224. Accessed Jul 2018.
  37. 37.
    Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2014;(3):CD009270.Google Scholar
  38. 38.
    Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, et al. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of con-trolled and observational evidence. J Neurol Neurosurg Psychiatry. 2018;89:741–53.CrossRefGoogle Scholar
  39. 39.
    Rhodes KM, Turner RM, Savović J, Jones HE, Mawdsley D, Higgins JPT. Between-trial heterogeneity in meta-analyses may be partially explained by reported design characteristics. J Clin Epidemiol. 2018;95:45–54.CrossRefGoogle Scholar
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    Devinsky O, Nabbout R, Miller I, Laux L, Zolnowska M, Wright S, et al. Maintenance of long-term safety and efficacy of cannabidiol (CBD) treatment in Dravet syndrome (DS): results of the open-label extension (OLE) trial (GWPCARE5) [abstract no. 1.289]. The American Epilepsy Society Annual Meeting; 1–5 Dec 2017; Washington, DC. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/343046. Accessed Jul 2018.
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    Marsh ED, Mazurkiewicz-Beldzinska M, Halford JJ, Gunning B, Checketts D, Nichol K, et al. Maintained safety and efficacy of cannabidiol (CBD) in a long-term open-label trial in patients with Lennox–Gastaut syndrome (LGS) (GWPCARE 5) [abstract no. 2.271]. The American Epilepsy Society Annual Meeting; 1–5 Dec 2017; Washington, DC. https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/344387. Accessed Jul 2018.
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    Szaflarski JP, Bebin EM, Comi AM, Patel AD, Joshi C, Checketts D, et al.; CBD EAP study group. Long-term safety and treatment effects of cannabidiol in children and adults with treatment-resistant epilepsies: expanded access program results. Epilepsia. 2018;59(8):1540–8.  https://doi.org/10.1111/epi.14477.CrossRefGoogle Scholar

via Efficacy and Safety of Cannabidiol in Epilepsy: A Systematic Review and Meta-Analysis | SpringerLink

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[REVIEW] Epilepsy and Cannabis: A Literature Review – Full Text PDF

Abstract

Epilepsy is considered to be one of the most common non-communicable neurological diseases especially in low to middle-income countries. Approximately one-third of patients with epilepsy have seizures that are resistant to antiepileptic medications. Clinical trials for the treatment of medically refractory epilepsy have mostly focused on new drug treatments, and result in a significant portion of subjects whose seizures remain refractory to medication. The off-label use of cannabis sativa plant in treating seizures is known since ancient times. The active ingredients of this plant are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), the latter considered safer and more effective in treating seizures, and with less adverse psychotropic effects.

Clinical trials prior to two years ago have shown little to no significant effects of cannabis in reducing seizures. These trials seem to be underpowered, with a sample size less than 15. In contrast, more recent studies that have included over 100 participants showed that CBD use resulted in a significant reduction in seizure frequency. Adverse effects of CBD overall appear to be benign, while more concerning adverse effects (e.g., elevated liver enzymes) improve with continued CBD use or dose reduction.

In most of the trials, CBD is used in adjunct with epilepsy medication, therefore it remains to be determined whether CBD is itself antiepileptic or a potentiator of traditional antiepileptic medications. Future trials may evaluate the efficacy of CBD in treating seizures due to specific etiologies (e.g., post-traumatic, post-stroke, idiopathic).[…]

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[WEB SITE] Medical Marijuana for Epilepsy: What We Know

Rahul Guha, MD, July 26, 2018

Earlier this year, the Virginia State Legislature voted to expand the medical cannabis oil program in the Commonwealth. I have patients ask me about medical marijuana during every clinic visit. Here are a few talking points that will help guide the discussion with your patients.

Patients usually start the conversation by saying, “I read on my cousin’s Facebook wall that smoking marijuana can treat my epilepsy.”

Let’s take a step back and talk about the clinically important compounds in marijuana. The first is tetrahydrocannabinol (THC). It exerts its effect through a pair of G protein-coupled cannabinoid receptors named, conveniently, CB1 and CB2. The effect of THC on synapses produces the typical “high” that allows you to tolerate 11-minute guitar solos and most items on Taco Bell’s late-night menu. Early animal models showed mixed effects of THC on epilepsy and, in some cases, worsening seizures. This is different from cannabidiol (CBD), which interacts with a variety of other receptors. More promising effects reported in early animal models and anecdotal evidence from case reports spurred the movement towards clinical trials measuring the effect of CBD on epilepsy.

Will medical marijuana help my epilepsy?

We don’t know which epilepsy syndromes are most responsive to CBD. We don’t know the long-term effects of CBD or THC in the brains of patients with epilepsy. We have not agreed on the best dosing strategy for these medications. The best evidence for CBD in epilepsy comes from two recently published trials studying the effect of the drug in patients with Lennox-Gastaut syndrome and Dravet syndrome.[1,2] These diseases develop in childhood or infancy due to underlying genetic changes and are resistant to treatment.

In the studies, patients who were taking an average of six other antiepileptic medications received CBD as an add-on therapy to conventional medications. At 3 months’ follow-up, patients who received the CBD experienced a statistically significant decrease in average seizure frequency compared with placebo.

Can I use commercially available CBD?

Unfortunately, many of the products that are available online or over the counter at your local vape shop are not consistent with labeling. Simply put, there’s no guarantee that you are getting what’s advertised. In addition to unknown dosing and concentrations of THC and CBD, there is a possibility of contaminants, such as pesticides or other drugs, in the product. We can only guarantee the safety and efficacy of US Food and Drug Administration (FDA)-approved products.

How will CBD affect my other medications?

CBD is metabolized by the liver and inhibits cytochrome P450 (CYP) isoenzymes. This inhibition leads to increased levels of topiramate, zonisamide, eslicarbazepine, rufinamide, clobazam, and valproic acid.

Is it legal?

The FDA recently approved a CBD formulation, but there is currently no formulation of CBD that can be prescribed with a Drug Enforcement Administration (DEA) license. Under federal law, cannabis is still considered a Schedule I drug. It is only available through clinical trials and rare compassionate-use exceptions. Patients and providers should familiarize themselves with local laws before recommending CBD for the treatment of epilepsy.

 

via Medical Marijuana for Epilepsy: What We Know

 

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[WEB SITE] Cannabis Oil for Epilepsy – What You Need to Know

Cannabis Oil for Epilepsy – What You Need to KnowCredit: Pixabay

via Cannabis Oil for Epilepsy – What You Need to Know | Technology Networks

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[Slideshow] Epilepsy & CBD

H Andre, O Danna, W Emma
… Scharfman and MacLusky, 2006 Page 34. Inhibition – Ledgerwood et al., 2010 ● CBD
is shown to inhibit synaptic transmission in hippocampal slices ○ In many forms of epilepsyseizures originate in the medial temporal lobe, an area that includes the hippocampus …

 

The Epilepsy & CBD Slideshow PDF file

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[WEB SITE] Epilepsy Drug With Marijuana-Based Ingredient Could Be Available In The US This Year

 By Allan Adamson Tech Times

A new class of epilepsy drugs based on a marijuana ingredient could be become available in the United States as early as the second half of 2018 pending approval from the Food and Drug Administration.

Epidiolex

GW Pharmaceuticals, the maker of the drug called Epidiolex, announced on Wednesday the promising results of a clinical study of the drug.

A group of 171 individuals were randomly assigned to either receive Epidiolex treatment or placebo. The participants were between 2 and 55 years old with a condition called Lennox-Gastaut syndrome. They were also suffering from seizures existing drugs cannot efficiently control.

The participants on average had tried and discontinued use of six anti-seizure treatments and were experiencing 74 “drop” seizures per month. This particular seizure involves the entire body, head and trunk, and often leads to fall and other injuries.

LGS Patients Taking Epidiolex Sees Significant Reduction Seizures

Results of the study, which was reported in the journal Lancet,  showed that over a period of 14 weeks, 44 percent of the patients taking the drug saw significant reduction in seizures. The rate is significantly higher compared with the 22 percent in the placebo group. More of those who were given the experimental drug also experienced a 50 percent or greater reduction in drop seizures.

“LGS is one of the most difficult types of epilepsy to treat and the majority of patients do not have an adequate response to existing therapies,” said Elizabeth Thiele, from Harvard Medical School. “These results show that Epidiolex may provide clinically meaningful benefits for patients with LGS.”

Epidiolex is based on pure marijuana-derived cannabidiol or CBD. The cannabis compound has been known for its medical benefits sans making people feeling “stoned.”

Adverse Events Linked To Use Of Epidiolex

Adverse events associated with use of the drug include diarrhea, decreased appetite, sleepiness, vomiting, and fever. Once given the go-signal to be marketed in the United States, the drug is intended to be used as a prescription drug to be dispensed by doctors.

“Add-on cannabidiol is efficacious for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome and is generally well tolerated. The long-term efficacy and safety of cannabidiol is currently being assessed in the open-label extension of this trial,” investigators wrote in their report.

GW Pharmaceuticals has not yet disclosed the pricing of the drug, but Justin Gover, GW’s chief executive officer, said that the company is already in talks with health insurers about coverage.

via Epilepsy Drug With Marijuana-Based Ingredient Could Be Available In The US This Year : Health : Tech Times

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[ARTICLE] Cannabinoids in the Treatment of Epilepsy: Hard Evidence at Last? – Full Text PDF

The interest in cannabis-based products for the treatment of refractory epilepsy has skyrocketed in recent years. Marijuana and other cannabis products with high content in Δ(9) –tetrahydrocannabinol (THC), utilized primarily for recreational purposes, are generally unsuitable for this indication, primarily because THC is associated with many undesired effects. Compared with THC, cannabidiol (CBD) shows a better defined anticonvulsant profile in animal models and is largely devoid of adverse psychoactive effects and abuse liability. Over the years, this has led to an increasing use of CBD-enriched extracts in seizure disorders, particularly in children. Although improvement in seizure control and other benefits on sleep and behavior have been often reported, interpretation of the data is made difficult by the uncontrolled nature of these observations. Evidence concerning the potential anti-seizure efficacy of cannabinoids reached a turning point in the last 12 months, with the completion of three high-quality placebo-controlled adjunctive-therapy trials of a purified CBD product in patients with Dravet syndrome and Lennox-Gastaut syndrome. In these studies, CBD was found to be superior to placebo in reducing the frequency of convulsive (tonic-clonic, tonic, clonic, and atonic) seizures in patients with Dravet syndrome, and the frequency of drop seizures in patients with Lennox-Gastaut syndrome. For the first time, there is now class 1 evidence that adjunctive use of CBD improves seizure control in patients with specific epilepsy syndromes. Based on currently available information, however, it is unclear whether the improved seizure control described in these trials was related to a direct action of CBD, or was mediated by drug interactions with concomitant medications, particularly a marked increased in plasma levels of N-desmethylclobazam, the active metabolite of clobazam. Clarification of the relative contribution of CBD to improved seizure outcome requires re-assessment of trial data for the subgroup of patients not comedicated with clobazam, or the conduction of further studies controlling for the confounding effect of this interaction. (2017;7:61-76) […]

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[WEB SITE] Can Cannabis Prevent and Treat Traumatic Brain Injury?

Traumatic Brain Injury, or TBI, is a serious condition usually caused by an external blow to the head that can cause severe and often chronic symptoms. These symptoms can be cognitive, behavioral, movement related, speech and visual impairing, mood altering, involve painful headaches, and even cause gastrointestinal issues.

Each year in just the U.S., nearly 52,000 people die from TBI and 80,000 sustain severe disabilities. Compare that to car fatalities (32,675) and homicides (14,196), which combined claim fewer lives. Moreover, 5.3 million people in the U.S. live with TBI-related disabilities, a number comparable to those living with Alzheimer’s disease.

How Cannabis Can Slow Traumatic Brain Injury Damage

Medical marijuana

While effective therapies to treat ongoing TBI symptoms have been difficult to come by, thanks to researchers like Prof. Yosef Sarne of Tel Aviv University, we’ve discovered that cannabis may prevent long-term brain damage by administering THC before or shortly after the injury. In fact, Israel Defense Force (IDF) practitioners administer CBD or low-dose THC as a first-line treatment to IDF soldiers – and even enemy combatants – who suffer brain trauma.

Sarne and his team published their results in 2013, where they demonstrated that administering just a fraction of the amount of THC that would be found in a typical cannabis joint anywhere from one to seven days prior to, or one to three days after an injury, induces the biochemical processes necessary to protect critical brain cells while preserving long-term cognitive function.

Can Cannabis Help People Currently Suffering From TBI?

Brain scan

Given the success found in Israel utilizing cannabis to halt TBI in its tracks, it begs the question: can cannabis help persistent TBI symptoms?

Anecdotally, many patients and their families report success. The daughter of one patient wrote in a Reddit forum:

“My father suffered severe TBI for years. He used to sit around hating his life all day. Once he started using marijuana, he changed a lot. He was able to get off some of his meds, start eating more, go outside, enjoy music, laugh at a movie, sleep at night, less anxiety in the day, less body pain. The list goes on and on.”

We hear many success stories like this, but these are, of course, anecdotal. Thus far, there aren’t any notable clinical trials demonstrating the efficacy of cannabis to treat ongoing symptoms in TBI patients. Unfortunately, even outside of cannabis research, phase II/III clinical trials of potential treatments haven’t demonstrated any consistent improvements in outcomes.

How Does Cannabis Consumption Affect the Brain?

The lack of cannabinoid-focused trials is likely due in part to the federal government’s long-standing position that cannabis is a “substance [with] no currently accepted medical use” and “a high potential for abuse” – a position that has long frustrated scientists who are forced to navigate significant bureaucratic obstacles to conduct high-quality rigorous studies.

Nonetheless, despite the federal government’s position, there is some evidence that at least lends support to speculation that cannabis-derived treatments may be beneficial:

Cannabinoids 101: What Makes Cannabis Medicine?

“Effect of Marijuana Use on Outcomes in Traumatic Brain Injury” (UCLA Medical Center, 2014):

In a three-year retrospective review of 446 separate cases of similarly injured patients, researchers found traumatic brain injury (TBI) patients who had a history of cannabis consumption possessed increased survival rates compared to non-consumers (97.6 percent survived surgery, versus 88.5% of those who didn’t consume cannabis).

“[O]ur data suggest an important link between the presence of a positive THC screen and improved survival after TBI,” the researchers concluded. “With continued research, more information will be uncovered regarding the therapeutic potential of THC, and further therapeutic interventions may be established.”

CTE in Professional Football Players, and the Potential of CBD to Address the Crisis

“Endocannabinoids and Traumatic Brain Injury” (Mechoulam, 2007):

This Israeli study points to research that demonstrates:

“…the [endocannabinoid] system…has the ability to [positively] affect the functional outcome after TBI by a variety of mechanisms.”

How Does Your Endocannabinoid System Impact Your Brain’s Response to Social Interaction?

“The Therapeutic Potential of the Cannabinoids in Neuroprotection” (Grundy RI, 2002):

This review shows that in experimental models:

“…various cannabinoids rescue dying neurons in experimental forms of acute neuronal injury, such as cerebral ischaemia and traumatic brain injury.”

5 Promising Cannabis Studies That Explore How Cannabinoids Interact with the Human Body

Positive results in experimental models don’t always translate to human subjects, hence the desperate need for more research. But, as early research shows promise and we know cannabinoids demonstrate neuroprotective effects in a variety of neurological conditions, there’s no excuse not to prioritize further research.

Further, because TBI is a condition affecting a highly complex, intricate system like the brain, successful strategies will likely involve more than a single “magic bullet.”

CBD Can Be Remarkably Effective for TBI

Patient receiving an MRI

In the meantime, as we continue to learn more about THC and other cannabinoids to treat traumatic brain injury, many physicians believe CBD can be a safe and effective treatment. CBD, a largely non-psychoactive cannabinoid that possesses neuroprotective, anti-inflammatory, and anti-anxiety properties, could be as close to a “magic bullet” as we have right now. In fact, CBD may be more beneficial than THC. Japanese researchers found cannabidiol (CBD) exhibited stronger antioxidative power than THC without creating tolerance to its neuroprotective effect.

Dr. Allan Frankel, of GreenBridge Medical in Santa Monica, California, believes incorporating small amounts of CBD as a daily nutritional supplement is a safe and sensible adjunct to therapy. “I had a patient recently, a 45 year mother who was in a bad car accident. She experienced memory loss, and hadn’t been making any progress. I suggested CBD,” recounts Frankel. “Within four to six weeks, she made significant progress – her cognitive function improved and her memory returned to normal.” Frankel notes that this is just one of many patients he’s had who have experienced successful recoveries.

While clearly there’s lots of promise in the limited research to date and anecdotal reports, we need to continue developing our understanding of cannabinoid neurobiology in order to most effectively exploit the numerous therapeutic properties of cannabis. We can then, hopefully, unleash the full spectrum of potential benefits cannabis may be able to provide and discover innovative new treatments that could quite possibly help the millions of people who continue to suffer.

How Does Cannabis Consumption Affect Neurodegenerative Diseases?

via Can Cannabis Prevent and Treat Traumatic Brain Injury? | Leafly

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[WEB SITE] Compound derived from marijuana interacts with antiepileptic drugs

New research published in Epilepsia, a journal of the International League Against Epilepsy (ILAE), suggests that an investigational neurological treatment derived from cannabis may alter the blood levels of commonly used antiepileptic drugs. It is important for clinicians to consider such drug interactions during treatment of complex conditions.

Cannabidiol (CBD), a compound developed from the cannabis plant, is being studied as a potential anticonvulsant, and it has demonstrated effectiveness in animal models of epilepsy and in humans. An ongoing open label study (Expanded Access Program) conducted by investigators at the University of Alabama at Birmingham is testing the potential of CBD as a therapy for children and adults with difficult to control epilepsy. The study includes 39 adults and 42 children, all of whom receive CBD.

Because all of the participants are also taking other seizure drugs while they are receiving the investigational therapy, investigators checked the blood levels of their other seizure drugs to see if they changed. “With any new potential seizure medication, it is important to know if drug interactions exist and if there are labs that should be monitored while taking a specific medication,” said lead author Tyler Gaston, MD.

Dr. Gaston and her colleagues found that there were significant changes in levels of the drugs clobazam (and its active metabolite N-desmethylclobazam), topiramate, and rufinamide in both adults and children, and zonisamide and eslicarbazepine in adults only. Except for clobazam/desmethylclobazam, however, the drug levels did not change outside of the normally accepted range. In addition, adult participants in the study taking clobazam reported sedation more frequently.

Tests also showed that participants taking valproate and CBD had higher ALT and AST (liver function tests) compared with participants not taking valproate. Very high ALT and AST indicate abnormal liver function, but significant ALT and AST elevation occurred only in a mall number of participants (4 children and 1 adult), and the levels returned to normal after discontinuation of valproate and CBD.

“While the interaction between CBD and clobazam has been established in the literature, there are currently no published human data on CBD’s potential interactions with other seizure medications,” said Dr. Gaston. “However, given the open label and naturalistic follow-up design of this study, our findings will need to be confirmed under controlled conditions.”

The findings emphasize the importance of monitoring blood levels of antiepileptic drugs as well as liver function during treatment with CBD. “A perception exists that since CBD is plant based, that it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs, has interactions with other seizure drugs that patients and providers need to be aware of,” said Dr. Gaston.

Article: Interactions between cannabidiol and commonly used antiepileptic drugs, Tyler E. Gaston, E. Martina Bebin, Gary R. Cutter, Yuliang Liu, Jerzy P. Szaflarski, and for the UAB CBD Program, Epilepsia, doi: 10.1111/epi.13852, published online 6 August 2017.

Source: Compound derived from marijuana interacts with antiepileptic drugs

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