Clinical Outcomes Associated with Prescription Cannabidiol Use at 12-months Post-initiation
Abstract number :
2.269
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2022
Submission ID :
2204004
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:22 AM
Authors :
Kayla Johnson, PharmD, BCPS, BCPP – Vanderbilt University Medical Center; Paige Barnes, PharmD Candidate – Lipscomb University College of Pharmacy; Holly Dial, PharmD Candidate – Lipscomb University College of Pharmacy; Wendi Owens, CPhT – Vanderbilt University Medical Center; Josh DeClercq, MS – Vanderbilt University Medical Center; Leena Choi, PhD – Vanderbilt University Medical Center; Nisha Shah, PharmD – Vanderbilt University Medical Center; Shilpa Reddy, MD – Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center; Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP – Vanderbilt University Medical Center
Rationale: There is limited data on real-world outcomes associated with use of prescription cannabidiol (CBD) therapy. The purpose of this study was to describe the use of emergency healthcare services, time to first emergency healthcare service use, and change in anti-seizure medication (ASM) use over the first 12-months of prescription CBD therapy.
Methods: This was a single-center, prospective cohort study of patients prescribed CBD by a neurology clinic provider and fulfilled through the center’s specialty pharmacy from January 2019 through April 2020. Patients enrolled in a clinical trial for CBD or for whom the insurance approval process was not completed by the center’s specialty pharmacy were excluded. Emergency healthcare service use, defined as an emergency department visit or hospital admission related to the epilepsy diagnosis, and changes in ASM therapy were collected for the study period which was 12-months post-prescription CBD initiation or until therapy discontinuation. Secondary outcomes included prescription CBD discontinuation rate along with reason for discontinuation, time to emergency healthcare service use, and changes in number of concurrent ASMs. Descriptive statistics were used to summarize the data with results presented as medians with interquartile ranges (IQR). Pediatric age was defined as less than 18 years.
Results: Inclusion criteria was met by 136 patients after screening 160 patients. The study population was 85% white, 50% female, and 68% pediatric. Patients had failed a median of 7 (IQR 5, 11) prior ASM treatments and were continued on a median of 3 (IQR 2, 4) concurrent ASMs prior to and at time of prescription CBD initiation, respectively. During the 12-month post-initiation period, 41 patients (30%) discontinued prescription CBD therapy. The most common reasons for discontinuation were lack of response (n=15, 37%), common side effects (n=13, 32%), and major side effects (n=5, 12%). During the study period, 20 patients (15%) had one emergency room visit with 9 patients (7%) having two or more for an epilepsy-related reason. At least one hospitalization occurred in 30 patients (22%) for an epilepsy related reason. Time to first emergency room visit and hospitalization was medians of 69 (IQR 31, 196) and 104 (IQR 38, 179) days, respectively. At the end of the 12-month monitoring period, patients were on a median of 3 concurrent ASMs (IQR 2, 3).
Conclusions: This study found emergency healthcare service utilization was common in the first 12-months after prescription CBD initiation with minimal change in concurrent ASM utilization. Longer term studies are needed to determine if ASM burden is decreased for patients who continued prescription CBD therapy for more than 12-months.
Funding: None
Anti-seizure Medications