Optimization of stable angina treatment: the results of the EPASS study
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Abstract
The aim – to evaluate the efficacy and safety of preparation of morpholinium salt of thiazotic acid in patients with stable angina in an open-label clinical non-randomized post-marketing study.
Materials and methods. The study EPASS included 30 patients aged an average of (73.1±1.8) years with a diagnosis of coronary heart disease, stable angina pectoris, functional class II–III. All patients in addition to the basic therapy received the study drug (SD) – Antares, solution for injection («Галичфарм», Ukraine) – at a dose of 50 mg/ml 4 ml of solution intramuscularly 2 times a day at a daily dose of 400 mg for 14 days. Then the patients took SD tablets – Antares, tablets («Київмедпрепарат», Ukraine) – 200 mg three times a day at a daily dose of 600 mg: 15 patients for 40 days and 15 patients for an average of 70 days. Patients underwent clinical and laboratory examination, daily monitoring of the electrocardiogram with calculation of frequent and spectral parameters of heart rate variability (HRV), transthoracic echocardiography, test with a 6-minute walking distance (6MWD).
Results and discussion. At the end of the course of treatment, all patients noted an improvement in general condition, a decrease in the intensity of pain and shortness of breath. In all patients, the walking distance increased significantly by an average of 21.6 %, in women – by an average of 19.8 %, in men – by an average of 22.7 %. Among patients with a median duration of treatment of 84 days, walking distance increased to a greater extent compared with that in the group of patients who received treatment for 54 days. The analysis of HRV parameters before the appointment of SD revealed a decrease in the activity of both the sympathetic and parasympathetic systems in the regulation of heart rate as a whole by group and depending on gender. After the course of treatment there was an increase in the total power of the spectrum and the restoration of the balance of autonomic regulation of the heart. Throughout the EPASS study, there was no early discontinuation of SD due to the development of serious adverse reactions; individual intolerance or hypersensitivity to thiazotic acid.
Conclusions. The results of the EPASS study showed the antianginal efficacy of SD and increased exercise tolerance by the 6MWD test in patients with stable angina in real clinical practice, including in patients older than 79 years. An increase in exercise tolerance with the duration of the course of SD on average 84 days compared with that for 54 days was established. Demonstrated the safety of SD, the absence of side effects and the need to cancel it throughout the study period.
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