Therapeutic drug monitoring in adolescents with anorexia nervosa for safe treatment with adjunct olanzapine

Author:

Karwautz Andreas1ORCID,Zeiler Michael1ORCID,Schwarzenberg Julia1,Mairhofer Dunja1,Mitterer Michaela1,Truttmann Stefanie1,Philipp Julia1,Koubek Doris1,Glüder Maria1,Wagner Gudrun1,Malcher Anouk1,Schöfbeck Gabriele1,Laczkovics Clarissa1ORCID,Rock Hans W.2,Zanko Annika3,Imgart Hartmut3,Banaschewski Tobias4,Fleischhaker Christian5,Correll Christoph U.6,Wewetzer Christoph7,Walitza Susanne8,Taurines Regina9,Fekete Stefanie9,Romanos Marcel9,Egberts Karin9ORCID,Gerlach Manfred9

Affiliation:

1. Eating Disorders Care and Research Unit Department of Child and Adolescent Psychiatry Medical University of Vienna Wien Austria

2. CIO Marburg GmbH Fronhausen Germany

3. Parklandklinik Bad Wildungen Germany

4. Department of Child and Adolescent Psychiatry and Psychotherapy Central Institute of Mental Health Medical Faculty Mannheim Mannheim Germany

5. Department of Child and Adolescent Psychiatry and Psychotherapy University Medical Center Freiburg Freiburg Germany

6. Berlin Department of Child and Adolescent Psychiatry Psychosomatic Medicine and Psychotherapy Charité University Medical Center Berlin Germany

7. Kliniken der Stadt Köln GmbH Clinic for Child and Adolescent Psychiatry Holweide Children's Hospital Amsterdamer Straße Cologne Germany

8. Department of Child and Adolescent Psychiatry and Psychotherapy University Hospital of Psychiatry Zurich Zürich Switzerland

9. Department of Child and Adolescent Psychiatry University of Würzburg Würzburg Germany

Abstract

AbstractObjectiveMedication is commonly used in anorexia nervosa (AN) despite largely missing high grade evidence. Olanzapine (OLZ) is the best‐evidenced substance used off‐label in this group, with conflicting outcome regarding BMI, clinical and safety parameters. Therefore, it is important to strictly assure quality of treatment with OLZ in AN by using ‘Therapeutic Drug Monitoring’ according to AGNP‐guidelines, including serum levels and adverse drug reactions (ADRs) to support safety for adolescents with AN and attempt to generate an initial age‐ and disorder‐specific therapeutic reference range.MethodSixty‐five adolescents with AN (aged 10–18) treated with OLZ (98% female; 97.5% AN‐restricting‐type) were prospectively observed, ADRs reported, and correlations between dosage and serum levels measured at trough level were calculated, a preliminary therapeutic range defined.ResultsMean dosage of OLZ was 8.15 (SD: 2.91) mg and 0.19 (SD: 0.07) mg/kg respectively, average concentration was 26.57 (SD: 13.46) ng/mL. Correlation between daily dosage/dosage per kg and serum level was 0.72 (**p < 0.001)/0.65 (**p < 0.001), respectively. ADRs with impairment were rare (6.3%). 75% improved clinically (CGI). BMI increased significantly by 1.5 kg/m2 (t = 10.6, p < 0.001). A preliminary therapeutic reference range is 11.9 and 39.9 ng/mL.ConclusionsOLZ in the hands of specialists is a well‐tolerated and safe treatment adjunct for adolescents with AN.

Funder

Bundesinstitut für Arzneimittel und Medizinprodukte

Publisher

Wiley

Subject

Psychiatry and Mental health,Clinical Psychology

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