ArticleFrontiers in pharmacology2026
Development and validation of a pharmacokinetic tool to convert random topiramate concentrations to standardized trough levels in bipolar disorder.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Topiramate is sometimes used in patients with bipolar disorder (BD), though off-label, warranting therapeutic drug monitoring (TDM) for safety. Guidelines recommend trough-level sampling (12-16h post-dose), but random levels are common, complicating interpretation. A tool to convert random topiramate concentrations to a standardized trough equivalent is lacking. Objective: To develop and validate a pharmacokinetic (PK) tool for estimating the standardized trough concentration at 14h post-dose (C Methods: A conversion model was derived using a one-compartment model with population PK parameters for immediate-release topiramate (elimination half-life = 25h, time-to-peak = 3h). A conversion coefficient (Kt) table was generated. The tool was validated against 183 paired TDM samples from inpatients with BD on stable topiramate monotherapy, using the measured C Results: The tool demonstrated excellent reliability (ICC = 0.92, 95% CI: 0.90-0.94) and agreement (mean bias = +0.008 μg/mL). Predictive accuracy was high (MAPE = 6.3%), with 97.3% of estimates having an absolute error <15%. Performance was consistent across pharmacokinetic phases and subgroups (age, dose). Conclusion: This preliminary PK conversion tool reliably estimates the standardized trough concentration of immediate-release topiramate from random TDM levels. It could potentially aid safety monitoring by improving the interpretation of non-standard samples, though its clinical utility requires prospective external validation and linkage to patient outcomes.
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