Patients with Lennox-Gastaut syndrome, a rare, severe form of epileptic encephalopathy, are frequently treatment resistant to available medications.
Until now there are few controlled studies that have investigated the use of cannabidiol for patients with seizures associated with Lennox-Gastaut syndrome.
But in this study, which was published on March 17,2018 in the Lancet Jurnals, the reserchers assessed the efficacy and safety of cannabidiol as an add-on anticonvulsant therapy in this population of patients.
The study...
In 24 clinical sites in the USA, the Netherlands, and Poland, reserchers investigated the efficacy of cannabidiol as add-on therapy for drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome.All patients had Lennox-Gastaut syndrome, including a history of slow spike-and-wave patterns on electroencephalogram, evidence of more than one type of generalised seizure for at least 6 months, at least two drop seizures per week during the 4-week baseline period, and had not responded to treatment with at least two antiepileptic drugs.
Patients were randomly assigned using an interactive voice response system, stratified by age group, to receive 20 mg/kg oral cannabidiol daily or placebo for 14 weeks.171 patients receive cannabidiol or placebo. All patients received at least one dose of study treatment and had post-baseline efficacy data. The primary endpoint was percentage change from baseline in monthly frequency of drop seizures during the treatment period.
The Results...
-The median percentage reduction in monthly drop seizure frequency from baseline was 43·9% in the cannibidiol group and 21·8% in the placebo group.
-The estimated median difference between the treatment groups was −17·21 (95%) during the 14-week treatment period.
-Adverse events occurred in 74 (86%) of 86 patients in the cannabidiol group and 59 (69%) of 85 patients in the placebo group most were mild or moderate.
-The most common adverse events were diarrhoea, somnolence, pyrexia, decreased appetite, and vomiting.
-12 (14%) patients in the cannabidiol group and one (1%) patient in the placebo group withdrew from the study because of adverse events. One patient (1%) died in the cannabidiol group, but this was unrelated to treatment.
The Conclusion...
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.
Sourse:https://www.thelancet.com
Until now there are few controlled studies that have investigated the use of cannabidiol for patients with seizures associated with Lennox-Gastaut syndrome.
But in this study, which was published on March 17,2018 in the Lancet Jurnals, the reserchers assessed the efficacy and safety of cannabidiol as an add-on anticonvulsant therapy in this population of patients.
The study...
In 24 clinical sites in the USA, the Netherlands, and Poland, reserchers investigated the efficacy of cannabidiol as add-on therapy for drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome.All patients had Lennox-Gastaut syndrome, including a history of slow spike-and-wave patterns on electroencephalogram, evidence of more than one type of generalised seizure for at least 6 months, at least two drop seizures per week during the 4-week baseline period, and had not responded to treatment with at least two antiepileptic drugs.
Patients were randomly assigned using an interactive voice response system, stratified by age group, to receive 20 mg/kg oral cannabidiol daily or placebo for 14 weeks.171 patients receive cannabidiol or placebo. All patients received at least one dose of study treatment and had post-baseline efficacy data. The primary endpoint was percentage change from baseline in monthly frequency of drop seizures during the treatment period.
The Results...
-The median percentage reduction in monthly drop seizure frequency from baseline was 43·9% in the cannibidiol group and 21·8% in the placebo group.
-The estimated median difference between the treatment groups was −17·21 (95%) during the 14-week treatment period.
-Adverse events occurred in 74 (86%) of 86 patients in the cannabidiol group and 59 (69%) of 85 patients in the placebo group most were mild or moderate.
-The most common adverse events were diarrhoea, somnolence, pyrexia, decreased appetite, and vomiting.
-12 (14%) patients in the cannabidiol group and one (1%) patient in the placebo group withdrew from the study because of adverse events. One patient (1%) died in the cannabidiol group, but this was unrelated to treatment.
The Conclusion...
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.
Sourse:https://www.thelancet.com
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