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- Title
Managing delayed or missed pregabalin doses in patients with focal epilepsy: a Monte Carlo simulation study.
- Authors
Xie, Helin; Zheng, You; Wang, Chenyu; Song, Shiwei; Dai, Yihai; Huang, Xian; Liu, Maobai; Wu, Xuemei
- Abstract
Background: Delayed or missed doses are inevitable in epilepsy pharmacotherapy. The current remedial measures recommended by the United States Food and Drug Administration (FDA) for non-adherence are generic and lack clinical evidence. Aim: To assess remedial strategies for delayed or missed pregabalin doses in patients with epilepsy using Monte Carlo simulations. Method: Monte Carlo simulations were performed using a published population pharmacokinetic model for pregabalin. The applicability of five proposed remedial regimens as well as FDA recommendations was evaluated by simulating various poor adherence scenarios in eight populations, including those with renal dysfunction. Results: All proposed remedial strategies were associated with delay duration and renal function. When delays are relatively short, an immediate regular dose is advised. The cut-off time points for taking the regular dose as a remedial regimen were 1, 2, 4, and 12 h for patients with mild renal impairment and normal renal function, moderate renal impairment, severe renal impairment, and end-stage renal disease, respectively. However, when delay aligns closely with a dosing interval, a regular dose combined with a partial dose proves effective. Generally, supplementing 1.3-fold the regular dose at the next scheduled time adequately compensates for the missed dose. Conclusion: Model-based simulations provided quantitative evidence for the effectiveness and feasibility of remedial strategies for missed or delayed pregabalin doses.
- Subjects
UNITED States. Food &; Drug Administration; MONTE Carlo method; PARTIAL epilepsy; PEOPLE with epilepsy; PREGABALIN; CHRONIC kidney failure
- Publication
International Journal of Clinical Pharmacy, 2024, Vol 46, Issue 1, p150
- ISSN
2210-7703
- Publication type
Article
- DOI
10.1007/s11096-023-01657-y