ANALYSIS OF SPONTANEOUS REPORTS OF ADVERSE REACTIONS IN PATIENTS WITH CORONARY ARTERY DISEASE IN THE REPUBLIC OF CRIMEA

Aim. To analyze spontaneous reports of adverse drug reactions in patients with coronary artery disease in the Republic of Crimea for the fve-year period from January 2011 to August 2016.

Methods. 332 reports of adverse drug reactions in patients with coronary artery disease collected in the “ARCADe” database were analyzed. Out of them, 231 reports on essential drugs affecting the cardiovascular system were selected. The age of patients who reported adverse drug reactions ranged from 37 to 90 years.

Results. The rate of adverse drug reaction reports increased with patients’ aging, reaching its maximum (31.6% of all drug reaction reports) by 70–80 years. The incidence of adverse reactions was higher among women (63.6%), which is generally consistent with other studies. However, men receiving nitrates had a 3.4-fold increase in the rate of adverse drug reactions compared to women. The highest rate of adverse drug reactions was associated with ACE inhibitors (29.0%), and in particular Enalapril, which is probably explained by a higher rate of their prescriptions, compared to other drugs.

Conclusion. Most of the reported adverse drug reactions were expected. The frequent development of allergic reactions (16% out of all adverse reactions in this study) in patients with coronary artery disease were associated with ACE inhibitors, betablockers and antithrombotic agents.

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