ArticleEuropean journal of clinical pharmacology2025
Optimizing therapeutic drug monitoring of mirtazapine - applying therapeutic reference range, concentration-dose ratio/dose-related concentration, and metabolic ratio in a naturalistic setting.
Article in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Optimizing Mirtazapine Initial Dosing: A Population Analysis of the Effects of BMI, Paroxetine and Fluvoxamine.Drug design, development and therapy · 2026Article
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5 authors.
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Abstract
purposeMirtazapine is a common antidepressant, regularly monitored through therapeutic drug monitoring. The previously published Consensus Guidelines in Neuropsychopharmacology provide data on the therapeutic reference ranges (TRR), dose-related concentrations (DRC), and metabolic ratios (MR). We aimed to investigate these TDM ranges in a real-world naturalistic setting to offer more practical, evidence-based recommendations.
methodsIn a retrospective single-center cohort study, we screened 361 patients with major depressive disorder undergoing mirtazapine treatment. Following the Consensus Guidelines (Hiemke et al., 2017), we compared three TDM tools in combination: (I) the TRR, (II) the concentration-to-dose (C/D) ratio with DRC factors, and (III) the MR.
resultsWe analyzed 328 patients (mean age 54 ± 16 years; 42% female). Serum levels of mirtazapine were below the TRR in 38% and above in 8%. Women exhibited an 18% higher C/D ratio compared to men, and elderly patients (> 65 years) demonstrated a 27% higher median C/D ratio than younger individuals. DRC values differed from the guideline-recommended ranges, likely due to higher dosing, unexpectedly lower serum values, interindividual pharmacokinetic variability, genetic polymorphisms, or polypharmacy. The median MR was 25% higher in women compared to men. Notably, 13 samples (4%) went beyond the designated MR range (either < 0.2 ng/mL or > 1.2 ng/mL).
conclusionsThis study provides real-world insights into established DRC values of mirtazapine. Observed age- and sex-related pharmacokinetic differences highlight the need for individualized dosing strategies, while further multicenter studies are needed to confirm their reproducibility.
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