DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20162249

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

Balwant K. Choure, Girish T. Raparti, Jayprakash B. Ramanand, Jyoti B. Tapase, Praveenkumar T. Patil, Nitin N. Puram, Rama R. Bhosale

Abstract


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.  


Keywords


ECG, Arrhythmia, Escitalopram, Sertraline, QTc

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References


Grover S, Kumar V, Avasthi A, Kulhara P. An audit of first prescription of new patients attending a psychiatry walk-in-clinic in north India. Indian J Pharmacol. 2012;44(3):319-25.

Taylor D. Antidepressant drugs and cardiovascular pathology: a clinical overview of effectiveness and safety. Acta Psychiatr Scand. 2008;118:434-42.

Witchel HJ, Hancox JC, Nutt DJ, Witchel HJ, Hancox JCND. Psychotropic drugs, cardiac arrhythmia, and sudden death. J Clin Psychopharmacol. 2003;23(1):58-77.

Pacher P, Kecskemeti V, Pal PVK. Cardiovascular side effects of new antidepressants and antipsychotics: new drugs, old concerns? Curr Pharm Des. 2004;10(20):2463-75.

Castro VM, Clements CC, Murphy SN. QT interval and antidepressant use : a cross sectional. 2013;288:1-11.

Tseng PT, Lee Y, Lin YE, Lin PY. Low-dose escitalopram for 2 days associated with corrected QT interval prolongation in a middle-aged woman: a case report and literature review. Gen Hosp Psychiatry. 2012;34(2):210-3.

Kocabay G, Yildiz M, Eksi Duran N, Ozkan M, Duran NE. Sinus arrest due to sertraline. Clin Cardiol. 2010;33(6):114-5.

Hanash JA, Hansen BH, Hansen JF, Nielsen OW, Rasmussen A, Birket SM. Cardiovascular safety of one-year escitalopram therapy in clinically nondepressed patients with acute coronary syndrome: results from the depression in patients with coronary artery disease (DECARD) trial. J Cardiovasc Pharmacol. 2012;60(4):397-405.

Thase ME, Larsen KG, Reines E, Kennedy SH. The cardiovascular safety profile of escitalopram. Eur Neuropsychopharmacol. 2013;23(11):1391-400.

Glassman AH, Oconnor CM, Califf RM, Swedberg K, Schwartz P, Bigger Jr JT, et al. Sertraline treatment of major depression in patients with acute MI or unstable angina. J Am Asso. 2002;288(6):701-9.

Wilens TE, Biederman J, March JS, Wolkow R, Fine CS, Millstein RB, et al. Absence of cardiovascular adverse effects of sertraline in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1999;38(5):573-7.

Okin PM, Devereux RB, Howard BV. Assessment of QT interval and QT dispersion for prediction of all-cause and cardiovascular mortality in American Indians: Strong Hear Study Circ. 2000;101:61-6.

Rabkin SW. Electrocardiographic abnormalities in apparently healthy men and the risk of sudden death. Drugs. 1984;28:28-45.

Lingeswaran A, Harshashetty, Kigshuklohan, Amitparamel SG. A letter to the editor. Ind J Ppharmacol. 2010;42.

Littmann L, Monroe MH. Brugada-type electrocardiographic pattern induced by cocaine. Mayo Clic Proc. 2000;75:845-9.

Daga B, Minano A, Puerta I, Pelegrin J, Rodrigo G. Electrocardiographic findings typical of brugada syndrome unmasked by cocaine consumption. Rev Esp Cardiol. 2005;58:1355-7.

Castro VM, Clements CC, Murphy SN, Gainer VS, Fava M, Weilburg JSB, et al. QT interval and antidepressant use: a cross sectional study of electronic health records. British Med J. 2013;346:288.

Fisch C, Knoebel SB. Electrocardiographic findings in sertraline depression trials. Drug Investig. 1992;4(4):305-12.

Hoehns JD, Fouts MM, Kelly MW, Tu KB. Sudden cardiac death with clozapine and sertraline combination. Ann Pharmacother. 2001;35(7):862-6.

Kocabay G, Yildiz M, Eksi DN, Ozkan M. Sinus arrest due to sertraline. Clin Cardiol. 2010;33(6):114-5.

Jiang W, Oconnor C, Silva SG, Kuchibhatla M, Cuffe MS, Callwood DD, et al. Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. Am Heart J. 2008;156(3):437-44.

Moss AJ. Measurement of the QT interval and the risk associated with QTc interval prolongation: a review. Am J Cardiol. 1993;72:23-5.

Stollberger C, Huber JO, Stollberger C, Huber JO, Finsterer J. Antipsychotic drugs and QT prolongation. Int Clin Psychopharmacol. 2005;20(5):243-51.

Harrigan EP, Miceli JJ, Anziano R, Watsky E, Reeves KR, Cutler NR et al. A randomized evaluation of the effects of six antipsychotic agents on QTc, in the absence and presence of metabolic inhibition. J Clin Psychopharmacol. 004;24:62-9.

Committee for proprietary medicinal products (CPMP). points to consider: the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. Eur. Agency Eval Med Prod. 1997;Available from: http://www.fda.gov/ohrms/dockets/ac/03/briefing/pubs/cpmp.pdf. Accessed on 12 February 2016.

Administration USF and D. Guidance for industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Food Drug Adm. 2005

Stockley’s drug interactions. Available at www.medicinescomplete.com. Accessed on 12 February 2016.