Safety of amisulpride in combination with antidepressants under common clinical practice conditions

Abstract

Aim. The main objective was to identify the occurrence of adverse events associated with amisulpride when combined with antidepressants (ADs). Methods. A non-interventional questionnaire-based study focussed on identification of occurrence and tolerance of combinations of amisulpride with ADs under common clinical practice conditions. Results. Combinations of amisulpride with ADs were administered to 3178 patients suffering from depression. The average daily dose of amisulpride was 54.8 ± 17 mg (range 50–150 mg/day). The most frequently administered ADs were SSRIs. A total of 4463 adverse events were recorded in 1624 (51%) of all treated patients. The most frequent adverse event was weight gain, followed by headache, fatigue and sleepiness. Only 2% of all adverse events were evaluated as adverse events of medium or high intensity. Higher occurrences of some adverse events were noted for specific combinations. Conclusion. The advantages of AD combinations undoubtedly include administration of lower doses and a reduction of adverse events associated with higher doses of individual ADs. On the other hand, adverse events can also sum. Nevertheless it is generally agreed that, in some patients, a combination of ADs, with different mechanisms of action, can be considered safe and effective polypharmacy.

Key Words::

• Depression
• combination of antidepressants
• amisulpride
• selective serotonin reuptake inhibitors
• adverse events

Acknowledgements

Non-interventional registry 010-2006-DEN was made by Infopharm, a.s. based on agreement and financial support from Sanofi-Aventis, s.r.o.

No financial fees were paid to the main author of manuscript Prof. Ceskova. The study was funded by a grant from the Ministry of Education, Czech Republic: No. MSM0021622404.

Statement of interest

None.