Abstract

Hepatotoxicity is the major safety concern in the case of agomelatine. Therefore, liver function should be monitored prior to treatment initiation and further in the 3rd, 6th, 12th and 24th week of treatment. According to a study conducted in 2016, adherence to the liver monitoring scheme is poor. We repeated this study to evaluate to what extent the monitoring of the liver function has changed.

We retrieved agomelatine prescriptions of new users for the period of June 2016 – July 2019 and all liver function tests of these patients for the period of May 2016 – July 2019 from the databases of the Estonian Health Insurance Fund. The same criteria were used in the present study for comparison with the results of the previous study.

During the study period there were 8,679 new agomelatine users, with a mean age of 47 years (SD = 17, range 3-96). Agomelatine was mainly prescribed by psychiatrists and general practitioners, at 48% and 44%, respectively, for depressive episodes (34%), anxiety disorders (25%) and recurrent depressive disorders (14%).

In 29% of the patients the test was performed before the initiation of treatment. In the previous study the corresponding indicator was 17%. At least one test was performed before the initiation of or during the whole treatment course in 57% of patients. Compared to the previous study, this indicator had increased by 13%.

There were 1,962 patients (23%) who had received agomelatine for at least 6 months. The majority (84%) of them had passed at least one test before the initiation
of or during the whole treatment course. Only for 5% of the patients were the tests performed according to the liver function scheme.
Despite the distribution of educational materials and an article published in the journal Eesti Arst, adherence to the liver monitoring scheme has improved scantily compared to the previous study. As druginduced liver injury can be serious and is largely unpredictable, regular monitoring of liver function is essential for safe use of agomelatine.