Comparison of Leviteracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis (P1.237)

Objective: To compare two leviteracetam dosing regimens in end-stage renal disease (ESRD) patients undergoing intermittent hemodialysis (IHD). Background: Leviteracetam (LEV) is primarily eliminated by the kidneys. In ESRD patients on IHD, previous pharmacokinetic studies have recommended daily dosing with a 50[percnt] supplemental dose after each 4-hr IHD session. However, poor medication compliance after IHD sessions could result in fluctuating plasma drug levels. Therefore, we sought to compare plasma leviteracetam levels of daily vs. twice-daily (BID) dosing. Design/Methods: Consecutive ESRD patients (April 2013 - May 2014) who received maintenance inpatient IHD and were prescribed leviteracetam prior to admission to an academic tertiary hospital in the Southeast US were prospectively analyzed. Demographics, initial lab values, seizures, and leviteracetam regimens were recorded. Leviteracetam levels were obtained pre- and post-dialysis along with levels after receiving a nightly dose. Recovery of plasma levels after IHD was assessed by comparison of levels pre-dialysis vs. post-dialysis and post-dose. Statistical significance was determined using Student’s t-test. Results: We identified 22 patients who met inclusion criteria; 14 on BID and 8 on daily dosing. Mean pre-dialysis, post-dialysis, and post-dose plasma levels were higher in patients receiving LEV BID compared to daily (43.1, 19.4, 34.9 vs. 21.1, 6.9, 11.9 mcg/mL; p<0.05). BID post-dialysis levels were 41.9[percnt] of pre-dialysis levels vs. 36.9[percnt] with daily dosing (p=0.275). Post-dose levels were 81.4[percnt] of pre-dialysis on LEV BID vs. 65.7[percnt] on LEV daily (p=0.045). No seizures were reported during hospital admission in either group. Conclusions: BID dosing of LEV achieved a post-dose level that was significantly higher and closer to pre-dialysis levels compared to LEV daily. While limited by small numbers, a similar relationship between post-dialysis levels was not detected. Future studies are needed to determine long-term tolerability and seizure prophylaxis. Disclosure: Dr. Shiue has nothing to disclose. Dr. Sands has nothing to disclose. Dr. Taylor has nothing to disclose.