A Post-Marketing Observational Study Investigating Efficacy and Tolerability of Escitalopram in Clinical Everyday Practice

Abstract

The SSRI antidepressant escitalopram is the S-(+)-enantiomer of the bicyclic phtalane derivate citalopram introduced first in Denmark in 1989 as a racemic compound and successfully used in psychiatric treatment for about two decades. We conducted a post-marketing observational study (PMOS) in order to assess the practical use, efficacy and tolerability of escitalopram under clinical everyday conditions. PMOS was conducted by analysis of medical records of 103 patients from the mental institutions of Regensburg and Mainkofen using a standardized data entry form. Moreover, we discussed the efficacy of escitalopram in comparison to its racemic parent citalopram based on the literature. Escitalopram was administered as first line antidepressant in 55.3% of patients. Incorporating patients pre-treated with other antidepressants only prior to hospitalization, escitalopram was chosen in 73.8% as first antidepressant in the hospital. One third of the patients received doses beyond the recommended dose range of 5–20mg/d; the mean daily dose was 21.7mg and thus 1.7fold higher than in prospective trials. In about 90% of patients, treatment with escitalopram was continued until discharge. Discontinuation rate due to lack of efficacy was about twice as high as in clinical trials. In 61.2% of patients, additional antidepressants and/or mood stabilizer were administered. CGI-S scores showed for inpatients less efficacy than in clinical trials (–1.24 vs. –2), but also a markedly higher severity at baseline (6.04 vs. 4.34). An average change in GAF score of 24.8 denoted a clinically relevant improvement. Overall, escitalopram was well tolerated. Total incidence of adverse events was 59.2%, about 10–20% lower than in clinical trials, and the discontinuation rate due to adverse events was about half as high. Most frequent adverse events were agitation (25.2%), diarrhoea (11.7%), dizziness (11.7%) and nausea (10.7%). Escitalopram showed a low interaction potential even in polypharmacotherapy. According to the literature, escitalopram shows no clinically relevant differences in overall analysis in efficacy as compared to citalopram in moderate to severe depression. In severely depressed patients, escitalopram was superior in terms of time until onset of action and in reduction of MADRS total score as well as in response rate. In PMOS, escitalopram was effective and well tolerated and confirmed the results of previous clinical trials. Therefore, escitalopram could be considered as a first line antidepressant in treatment of depressive disorders.