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Impact of age and CYP2D6 genotype on exposure of zuclopenthixol in patients using long-acting injectable versus oral formulation-an observational study including 2044 patients

Tveito, Marit; Smith, Robert Løvsletten; Molden, Espen; Høiseth, Gudrun
Journal article; AcceptedVersion; Peer reviewed
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Item resctricted until:2021-09-30
Postnr+1837821_ ... _draft_post_refereeing.pdf (1.826Mb)
Year
2020
Permanent link
http://urn.nb.no/URN:NBN:no-84432

CRIStin
1837821

Metadata
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Appears in the following Collection
  • Institutt for klinisk medisin [5635]
  • Farmasøytisk institutt [1364]
  • CRIStin høstingsarkiv [15979]
Original version
European Journal of Clinical Pharmacology. 2020, 1-7, DOI: https://doi.org/10.1007/s00228-020-03002-y
Abstract
Purpose

Zuclopenthixol is an antipsychotic available as oral and long-acting injectable (LAI) formulations. The aim of this study was to investigate the effect of age on zuclopenthixol exposure during oral and LAI administrations without and with adjustment for CYP2D6 genotype.

Methods

Data on serum concentrations of zuclopenthixol and CYP2D6 genotype (available for 28.2% of the population) from patients using oral or LAI zuclopenthixol were included retrospectively from a therapeutic drug monitoring service during the period 2005–2019. As a measure of exposure, dose-adjusted serum concentration (C/D ratio) was used. Based on age, patients were grouped to older (≥ 65 years) or younger (18–64 years). Linear mixed model analyses without and with adjustment for CYP2D6 genotype were used.

Results

Serum concentrations of zuclopenthixol from 1145 (14.1% older) and 899 patients (24.6% older) in the LAI and oral groups were included, respectively. Compared with younger patients, older patients had a higher C/D ratio of zuclopenthixol for LAI (+ 25–33%, p < 0.001) and oral formulation (+ 25–29%, p ≤ 0.003) without and with adjustment for CYP2D6 genotype. The doses were lower in older versus younger patients (oral: − 30%; LAI: − 20%; p < 0.001). Compared with the younger LAI users without reduced CYP2D6 function, a higher C/D ratio was observed in the older LAI users with reduced CYP2D6 function (+ 104%, p < 0.001).

Conclusion

The present study showed that zuclopenthixol exposure increases in older patients and that the older LAI users with reduced CYP2D6 function are exposed to high serum concentrations. Also, the present study showed that similar dose reductions are required for oral and LAI users.
 
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