Post-marketing comparative clinical study of the efficacy and safety of Iso-Mik® spray and sublingual form of nitroglycerin

September 6, 2023
УДК:  616.12-009.72+615.22

In Ukraine, in recent years, the number of cases and the incidence of angina has increased significantly, and forecast indicators indicate a trend of their growth.

Purpose: to study the comparative effectiveness and safety of isosorbide dinitrate — sublingual dosed spray Iso-Mik® and nitroglycerin tablets in patients with angina pectoris.

Object and research methods. The study included 30 patients with ischemic heart disease, stable angina pectoris II–III functional class aged 50 to 75 years. The average number of attacks was 12.7±1.0 per week. Patients used short-acting nitrates in tablet form to stop angina attacks — an average of 9.4±0.8 tablets per week against the background of modern medical therapy. Each patient performed two study protocols. Protocol 1 included a study of the effectiveness and safety of the sublingual form of nitroglycerin, protocol 2 was performed by each patient at least 24 hours after the completion of protocol 1 and included a study of the effectiveness and safety of the dosed drug Iso-Mik® spray.

The results. A post-marketing comparative study showed that Iso-Mik® spray is an effective antianginal drug in real clinical practice, which is well tolerated and does not cause side effects compared to nitroglycerin tablets. With an attack of angina pectoris, the use of Iso-Mik® spray almost halves the time it takes to stop the attack and significantly increases the duration of physical activity compared to nitroglycerin tablets.


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