Publication:

Comparison of cardiovascular safety of escitalopram and sertraline based on electrocardiographic alterations: a pharmacovigilance study

Background Escitalopram and sertraline are the most commonly prescribed antidepressant drugs, belongs to SSRI class. Both the drugs are long been considered as free from cardiovascular adverse effects. Recently number of studies reported potential association between these drugs and pronounced cardiovascular adverse effects. ECG changes like prolongation of QT interval are frequently used as markers for the increased risk of a fatal cardiac arrhythmia. The potential cardiovascular adverse reaction profile of both these drugs is little studied in Indian rural population.

Methods This was a 6 weeks prospective open label observational study carried out in a drug naive 209 patients receiving either escitalopram (n=106) or sertraline (n=103). ECG parameters like heart rate, RR interval, PQ/PR interval, QRS duration and QTc interval, were obtained directly from the digital machine recordings, additionally the QT interval was measured manually with the help of caliper. Statistical analysis was done by using Statistical software SPSS 17.0.

Results Out of 209 drugs naive patients, 12 from escitalopram group and 10 patients from Sertraline were lost to follow-up. Hence ECG recordings of the remaining 94 patients under escitalopram group, 93 patients under sertraline group were used for study analysis. The ECG alterations caused by the escitalopram were compared with that caused by sertraline. It was observed that the differences between the ECG alterations caused by either of escitalopram or sertraline were statistically non-significant.

Conclusions It was concluded, at therapeutic doses neither of the drugs have the potential risk of drug induced arrhythmias, throughout the study.