Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase
Abstract
:1. Introduction
2. Results
2.1. Characteristics of the Reports
2.2. Disproportionality Analysis
2.3. Characteristics of Insomnia Reports
3. Discussion
4. Material and Methods
4.1. Case of Interest Definition
4.2. Exposure Definition
4.3. Statistical Analysis
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
CBD | cannabidiol |
CB1 | cannabinoid receptors 1 |
CB2 | cannabinoid receptor 2 |
CI | confidence interval |
ENT-1 | equilibrative nucleoside transporter type 1 |
FAAH | fatty-acid amide hydrolase 1 |
GPR55 | G protein-coupled receptor 55 |
HLT | Higher-Level Terms |
8-OH-DPAT | 8-hydroxy-2-(di-n-propilamino)tetralin |
IC | information component |
ICSRs | individual case safety report |
MedDRA | Medical Dictionary for Regulatory Activities |
PTs | Preferred Terms |
READUS-PV | Reporting of A Disproportionality analysis for drUg Safety signal detection using spontaneously reported adverse events in Pharmacovigilance |
ROR | Reporting odds ratio |
SSRIs | selective serotonin reuptake inhibitors |
THC | delta-9-tetrahydrocannabinol |
TRPV | transient receptor potential vanilloid |
UMC | Uppsala Monitoring Centre |
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Main Characteristics | N° Cases (820) | % |
---|---|---|
Patient Age | ||
28 days–23 months | 1 | 0.1% |
2–11 years | 23 | 2.8% |
12–17 years | 23 | 2.8% |
18–44 years | 57 | 7.0% |
45–64 years | 18 | 2.2% |
65–74 years | 6 | 0.7% |
≥75 years | 6 | 0.7% |
Unknown | 685 | 83.5% |
28 days–23 months | 1 | 0.1% |
Sex | ||
Male | 149 | 18.2% |
Female | 147 | 17.9% |
Unknown | 524 | 63.9% |
Countries | ||
USA | 754 | 92.0% |
UK | 18 | 2.2% |
France | 12 | 1.5% |
Germany | 8 | 1.0% |
other countries | 28 | 3.4% |
Reporter qualification | ||
Physician | 154 | 18.8% |
Pharmacist | 22 | 2.7% |
Other Health Professional | 179 | 21.8% |
Consumer/Non Health Professional | 463 | 56.5% |
Unknown | 8 | 1.0% |
Drug/Product | ||
Epidiolex | 753 | 91.8% |
Unknown (Cannabidiol) | 47 | 5.7% |
CBD oil | 15 | 1.8% |
Convupidiol (Argentina) | 3 | 0.4% |
Xannadiol (Uruguay) | 2 | 0.2% |
Indication | ||
Epilepsy NOS | 200 | 24.4% |
Lennox Gastaut Syndrome | 315 | 38.4% |
Seizures | 40 | 4.9% |
Partial seizure | 41 | 5% |
Idiopatic epilepsy | 34 | 4.1% |
Tuberous Sclerosis Complex | 11 | 1.3% |
Product use for unknown indication | 79 | 9.6% |
Other indications | 100 | 12.2% |
Serious/non serious adverse reactions | ||
Yes | 233 | 28.4% |
No | 587 | 71.6% |
Adverse Reaction | N. of Cases | ROR (95% CI) | IC (IC025) |
---|---|---|---|
Weight decreased | 456 | 5.19° (4.54–5.70) | 2.4 * (2.2) |
Hypophagia | 30 | 3.68° (3.22–5.27) | 1.8 * (1.3) |
Insomnia | 221 | 1.60° (1.40–1.83) | 0.7 * (0.5) |
Dizziness | 118 | 0.23 (0.20–0.27) | −2.1 (−2.4) |
Palpitations | 16 | 0.12 (0.10–0.19) | −3.1 (−3.9) |
Main Characteristics | N° Cases (221) | % |
---|---|---|
Patient Age | ||
2–11 years | 8 | 3.6% |
12–17 years | 5 | 2.3% |
18–44 years | 4 | 1.8% |
45–64 years | 4 | 1.8% |
65–74 years | 2 | 0.9% |
≥75 years | 2 | 0.9% |
Unknown | 196 | 88.7% |
Sex | ||
Male | 28 | 12.7% |
Female | 25 | 11.3% |
Unknown | 168 | 76.0% |
Drug/Product | ||
Epidiolex | 206 | 93.2% |
Unknown Cannabidiol | 11 | 5.0% |
CBD oil | 2 | 0.9% |
Convupidiol (Argentina) | 2 | 0.9% |
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Calapai, F.; Mannucci, C.; McQuain, L.; Salvo, F. Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Pharmaceuticals 2023, 16, 1420. https://doi.org/10.3390/ph16101420
Calapai F, Mannucci C, McQuain L, Salvo F. Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Pharmaceuticals. 2023; 16(10):1420. https://doi.org/10.3390/ph16101420
Chicago/Turabian StyleCalapai, Fabrizio, Carmen Mannucci, Liana McQuain, and Francesco Salvo. 2023. "Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase" Pharmaceuticals 16, no. 10: 1420. https://doi.org/10.3390/ph16101420