Graphical Presentation of Increases in Seizure Frequency in Anti-seizure Medication Trials: A Comparative Analysis of Fda-approved Labels and Peer-reviewed Publications
Abstract number :
3.403
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2024
Submission ID :
152
Source :
www.aesnet.org
Presentation date :
12/9/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Christopher Henry, MD – Children's Hospital of Richmond at VCU Health
Miranda Creasey, MD – VCU Health
LaMont Cannon, PhD – Virginia Commonwealth University
Samuel Terman, MD, MS – University of Michigan
Daniel Goldenholz, MD PhD – BIDMC
Rationale: Assess the difference in graphical representation of the percentage of patients showing increased seizure frequency (SF) in anti-seizure medication (ASM) trials between the U.S. Food and Drug Administration (FDA) approved prescribing labels and those in the peer-reviewed literature.
Methods: We searched the peer-reviewed literature for the initial publication of the randomized clinical efficacy trials referenced in the prescribing labels for the 16 most recently FDA-approved ASMs for adjunctive treatment of epilepsy. We then assessed whether a systematic difference existed in the choice to graphically display the percentage of patients with an increase in SF.
Results: The FDA-approved label graphically displayed increasing SF data for 77% of the studies (33 out of 43). The peer-reviewed publications of the same studies did so in 23% (10 out of 43). This increased to 51% (22 out of 43) when text and tables were included. Eight studies did not display the data in either publication setting. Out of the 11,654 patients in the 43 studies an estimated 3,158 (27%) patients had an increase in SF. The median percentage of patients with an increase on placebo was 34% compared to 24% in the treatment arm. The FDA-approved label displayed the data for an estimated 2,477 (78%) of the patients with an increased SF compared to the estimated 558 (18%) in the peer-reviewed publication of the same studies. If tables and text were included this only improved the peer reviewed publications delineation to 1,130 (36%) of the patients with an increased SF.
Conclusions: Compared to FDA-approved labels, the peer-reviewed publications of the last 16 FDA-approved ASMs under-informed clinicians about the percentage of patients with increased SF, which may impact informed shared decision-making.
Funding: DMG was supported by NINDS K23NS124656.
Anti-seizure Medications