BACKGROUND: Hepatotoxic reactions are an important identified risk listed in the agomelatine Risk Management Plan. This post-authorisation safety study evaluated the effectiveness of additional risk-minimisation measures (RMMs) for agomelatine.
OBJECTIVE: To evaluate, among physicians prescribing agomelatine and their patients, liver monitoring adherence, compliance with contraindications, and patients’ reasons for non-compliance with liver monitoring.
METHODS: A non-interventional cohort study was conducted among adults initiating agomelatine in routine clinical practice in Denmark, France, Germany, and Spain, through a retrospective medical record abstraction (MRA) before and after implementation of RMMs and a cross-sectional patient survey.
RESULTS: Fifty-four sites contributed data on 437 and 404 patients in the before- and after-RMM periods, and 237 patients in the survey. No patient had cirrhosis in either study period; 98.2% of patients in the before- and 98.0% in the after-RMM period had no active liver disease reported at initiation or during treatment. Compliance to contraindicated medications was >99% in both periods. The adherence to the liver-monitoring regimen was similar in both periods (15.1% before RMM and 16.3% after RMM). In the after-RMM period, 25.2% of patients had a liver test before or at treatment initiation; 61.5% had a liver test during treatment. Among patients surveyed who did not have a blood test before treatment initiation or during treatment, the most frequently cited reason was a test ordered but not yet performed.
CONCLUSIONS: The overall adherence to liver-monitoring recommendations remained weakly influenced by additional RMMs. However, patients treated with agomelatine are in compliance with relevant contraindications.
