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Introduction <p>Effectiveness and tolerability of plant-derived highly purified cannabidiol (CBD) in patients with Lennox–Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC)-associated epilepsy in clinical practice in Germany were evaluated.</p> Methods <p>This multicenter, retrospective, chart review study analyzed patients with LGS, DS, or TSC-associated epilepsy receiving ≥ 1&#xa0;dose of adjunctive CBD (Epidyolex<sup>®</sup> 100&#xa0;mg/mL oral solution). Treatment characteristics, seizure outcomes, physician-rated Clinical Global Impression of Change (CGI-C), treatment retention rates, and adverse events (AEs) were analyzed ≤ 12&#xa0;months.</p> Results <p>Among 202 patients identified (159 LGS; 34 DS; 9 TSC), median (interquartile range; range) age was 18.0 (7.9–32.0; 0.3–72.0) years, and median (range) number of prior and concomitant antiseizure medications was 6 (1–24) and 3 (1–7), respectively. Median target CBD dose was 11.1&#xa0;mg/kg/day (17.6, 15.2, and 9.9&#xa0;mg/kg/day in the &lt; 6, 6–17, and ≥ 18&#xa0;years subgroups, respectively). Responder rates (≥ 50% seizure reduction) for total seizures at 3 (<i>n</i> = 194) and 12 (<i>n</i> = 168) months were 43.3% (37.0–50.0% across ages) and 44.0% (37.0–52.5% across ages), respectively, and for generalized tonic–clonic seizures 54.3% (<i>n</i> = 94) (50.0–66.7% across ages) and 47.7% (<i>n</i> = 88) (37.8–66.7% across ages), respectively. Median (range) number of seizure days per month significantly decreased from 30 (0.3–30) to 18 (0–30) in the 3&#xa0;months before the last 3&#xa0;months of CBD treatment (<i>p</i> &lt; 0.001). Any improvement in CGI-C was observed in 62% of patients. Of those with available data at 3 and 12&#xa0;months, 89.6% and 67.1% remained on CBD, respectively. Retention was similar across age groups. AEs reported in ≥ 5% of patients were sedation and diarrhea.</p> Conclusions <p>In patients with LGS, DS, or TSC-associated epilepsy, adjunctive CBD was associated with a reduction in seizure frequency across age groups. CBD demonstrated tolerability consistent with its known profile, and 67% of patients remained on treatment at 12&#xa0;months.</p> Graphical Abstract <p></p>

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Retrospective Multicenter Chart Review Study of Adjunctive Cannabidiol for Seizures Associated with Lennox–Gastaut Syndrome, Dravet Syndrome and Tuberous Sclerosis Complex

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  • 发表日期：

    2025年7月12日

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  • Adam Strzelczyk,
  • Kerstin Alexandra Klotz,
  • Thomas Mayer,
  • Felix von Podewils,
  • Susanne Knake,
  • Gerhard Kurlemann,
  • Luise Herold,
  • Ilka Immisch,
  • Elisa Buhleier,
  • Felix Rosenow,
  • Susanne Schubert-Bast

摘要

Introduction

Effectiveness and tolerability of plant-derived highly purified cannabidiol (CBD) in patients with Lennox–Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC)-associated epilepsy in clinical practice in Germany were evaluated.

Methods

This multicenter, retrospective, chart review study analyzed patients with LGS, DS, or TSC-associated epilepsy receiving ≥ 1 dose of adjunctive CBD (Epidyolex® 100 mg/mL oral solution). Treatment characteristics, seizure outcomes, physician-rated Clinical Global Impression of Change (CGI-C), treatment retention rates, and adverse events (AEs) were analyzed ≤ 12 months.

Results

Among 202 patients identified (159 LGS; 34 DS; 9 TSC), median (interquartile range; range) age was 18.0 (7.9–32.0; 0.3–72.0) years, and median (range) number of prior and concomitant antiseizure medications was 6 (1–24) and 3 (1–7), respectively. Median target CBD dose was 11.1 mg/kg/day (17.6, 15.2, and 9.9 mg/kg/day in the < 6, 6–17, and ≥ 18 years subgroups, respectively). Responder rates (≥ 50% seizure reduction) for total seizures at 3 (n = 194) and 12 (n = 168) months were 43.3% (37.0–50.0% across ages) and 44.0% (37.0–52.5% across ages), respectively, and for generalized tonic–clonic seizures 54.3% (n = 94) (50.0–66.7% across ages) and 47.7% (n = 88) (37.8–66.7% across ages), respectively. Median (range) number of seizure days per month significantly decreased from 30 (0.3–30) to 18 (0–30) in the 3 months before the last 3 months of CBD treatment (p < 0.001). Any improvement in CGI-C was observed in 62% of patients. Of those with available data at 3 and 12 months, 89.6% and 67.1% remained on CBD, respectively. Retention was similar across age groups. AEs reported in ≥ 5% of patients were sedation and diarrhea.

Conclusions

In patients with LGS, DS, or TSC-associated epilepsy, adjunctive CBD was associated with a reduction in seizure frequency across age groups. CBD demonstrated tolerability consistent with its known profile, and 67% of patients remained on treatment at 12 months.

Graphical Abstract