Cardiac safety of citalopram: Prospective trials and retrospective analyses

The selective serotonin reuptake inhibitors (SSRIs) are believed to have a more benign cardiovascular safety profile than do the tricyclic antidepress ants. The effects of the SSRI citalopram on cardiac conduction and repolari zation have been extensively evaluated, both in prospective studies in volu nteers and patients and in retrospective evaluations of all electrocardiogr aphic (ECG) data from rib clinical trials conducted from 1978 through 1996 (a total of 40 studies). A randomized, double-blind, placebo-controlled stu dy was conducted in healthy volunteers (N = 23) to assess intraindividual v ariability of the QT(c) interval, as well as possible changes during treatm ent with placebo or citalopram, and its correlation to plasma drug levels. To document any dose-related changes, ECGs were performed at baseline and a t the end of study in three randomized, double-blind, placebo- or active-co ntrolled, fixed-dose trials in adult and elderly patients (N = 1,460) with major depression and/or dementia, Finally, more than 6,000 ECGs (N = 1,789 citalopram-treated patients) collected from all clinical trials conducted f rom 1978 through 1996 were reassessed in a standardized manner to identify any effects of citalopram on ECG parameters. Results of both prospective an d retrospective analyses showed that the only effect of citalopram on ECG f indings is a small reduction in heart rate (less than or equal to 8 beats p er minute). There mere no significant effects on PQ, QRS, or QT(c) interval s, indicating that citalopram has no effect on cardiac conduction and repol arization during short- or long-term treatment.