Authors :
Hollyann Brown, PharmD – Orlando Health
Presenting Author: Michel Abdelmasih, MD – Orlando Health
Brannon Inman, MD – Orlando Health
Sydney McNeill, PharmD, BCCCP – Orlando Health
Kara Birrer, PharmD, BCPS – Orlando Health
Mai Vo, MD – Orlando Health
Dipali Nemade, MD, MPH – Orlando Health
Rationale:
Brivaracetam (BRV) is a Synaptic Vesicle 2 Protein (SV2A) selective anti-seizure medication (ASM), approved in 2016 for the treatment of partial-onset seizures as monotherapy or adjunctive therapy. All three of the original phase III trials that gained BRV FDA approval did not include patients with end-stage renal disease on renal replacement therapies (RRT). Also, there were only 38 older adults included, and these patients are often at higher risk for renal dysfunction. Given these trials, the use of BRV is currently not recommended for patients requiring RRT; however, there is no dose adjustment recommended in patients with renal dysfunction on RRT. BRV undergoes primarily hepatic metabolism to inactive metabolites, suggesting that use in altered renal function may be safe. Sargentini-Maier and colleagues published a pharmacokinetic study finding that the maximum concentration and volume of distribution of BRV were not modified by creatinine clearance (CrCl) < 30 mL/min (2012). This study aims to assess the safety of BRV in patients with severe renal dysfunction, defined by a CrCl of less than 50 mL/min.
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Methods:
This was a retrospective descriptive study conducted at a single site of patients ≥18 years old admitted between May 1st, 2021, and December 2nd, 2024. Patients were included if they received at least one dose of BRV and had a CrCl < 50 mL/min at the time of the first dose. The primary outcome was a composite of adverse drug events (ADE) defined as either somnolence, dizziness, headache, agitation, or any other ADE leading to discontinuation, change, or dose reduction of BRV. Secondary outcomes included seizure freedom based on electroencephalogram (EEG) reports, 50% seizure reduction, and dosing description. Safety outcomes included the individual components of the composite outcome. Study data were collected and managed using REDCap©.
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Results:
Forty-nine patients were included in the study. Baseline characteristics are highlighted in Table 1. The median age was 71 years, and nearly half of the patients were on hemodialysis (HD) on admission. Two-thirds of patients were admitted to the ICU. The majority of patients were newly initiated on BRV, with over half of these patients being started after a documented seizure. The most common ADE experienced was somnolence; however, 93% of these patients were admitted to the ICU, and half of these patients were on HD. The median total daily dose of BRV was 200 mg. Eighteen patients were loaded with BRV, averaging a dose of 1 mg/kg, or approximately 200 mg.
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