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Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess
Emmanuelle Jacquot1, Estelle Collin1, Amy Ladner2
1Institut de Recherches Internationales Servier, Paris, France.
Pharmaceutical Medicine
|January 15, 2020
Summary
Additional risk-minimisation measures (aRMMs) for agomelatine showed minimal impact on liver function monitoring adherence. Patients demonstrated high compliance with contraindications, but liver monitoring rates remained low.
Area of Science:
- Pharmacovigilance
- Hepatology
- Clinical Pharmacology
Background:
- Agomelatine carries a risk of hepatotoxic reactions, necessitating a risk management plan.
- This study assesses the effectiveness of additional risk-minimisation measures (aRMMs) implemented for agomelatine.
Purpose of the Study:
- To evaluate liver function monitoring adherence among physicians and patients prescribed agomelatine.
- To assess compliance with contraindications and identify reasons for non-compliance with liver monitoring.
Main Methods:
- A non-interventional cohort study involving retrospective medical record abstraction (MRA) before and after aRMM implementation.
- A cross-sectional patient survey was conducted in Denmark, France, Germany, and Spain.
Main Results:
- Liver monitoring adherence remained similar before (15.1%) and after (16.3%) aRMMs.
- Compliance with contraindications exceeded 99% in both study periods.
- In the post-aRMM period, 25.2% of patients had baseline liver tests, and 61.5% had tests during treatment.
Conclusions:
- Additional risk-minimisation measures had a weak influence on overall adherence to liver monitoring recommendations.
- Patients treated with agomelatine demonstrated high compliance with relevant contraindications.
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