Roughley, Matthew; Mena Poblete, Carlos; Howard, Robert; Reeves, Suzanne; Bertrand, Julie; (2023) Guiding safer risperidone prescribing in Alzheimer's disease with therapeutic drug monitoring. British Journal of Clinical Pharmacology , 89 (7) pp. 2316-2321. 10.1111/bcp.15692.

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Abstract

Previous analysis of pharmacokinetic data on risperidone-treated patients with dementia predicted that 20% had concentration-to-dose (C/D) ratios of the active moiety (risperidone and 9-hydroxy(OH)-risperidone) above 14 ng/mL per mg/day, which were in turn associated with a greater risk of extrapyramidal side effects. This study aimed to further explore risperidone pharmacokinetics in a second dataset. Nonlinear mixed effects modelling, using a Bayesian approach, was applied to data from a randomized controlled trial of risperidone in people with dementia. Covariates included age and glomerular filtration rate (GFR). Age had a significant effect on risperidone clearance (β = −1.5) and GFR on 9-OH-risperidone clearance (β = 0.2). The model predicted that 26.2% (95% confidence interval 18.6-32.6%) had C/D ratios above 14 ng/mL per mg/day. These findings confirm the importance of age-related risperidone dose adjustments and argue strongly for therapeutic drug monitoring in the initial stages of treatment to identify those at greatest risk of toxicity.

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