Abstract
Aim . To study the therapeutic efficacy and safety of generic drug of ivabradine in comparison with the original drug in patients with stable angina. Material and methods. Patients with stable angina of II-III functional class (n=20) were included into an open randomized pilot study with a crosssectional design. Inclusion criterion: heart rate >70 beats/min during the use of beta-blockers. The comorbid cardiac pathology was represented by arterial hypertension of 1-3 degrees and chronic heart failure of I-III functional class. Initially, all patients underwent a clinical examination. Patients were randomized into the Group 1 receiving the original (Coraxan®, Servier,Serdix,Russia) or Group 2 receiving generic (Raenom®,Gedeon Richter,Hungary) drug of ivabradine (in addition to ongoing therapy), 5 mg BID. During the following month, the patients were monitored weekly. If necessary, the doses of the studied drugs were adjusted to achieve the target values of clinical indicators. After 4 weeks of therapy, study drugs in groups were replaced in equivalent doses; patients were observed for another 4 weeks. Results. A statistically significant decrease in heart rate (from 82.5±6.63 to 66.3±6.18 beats/minute in Group 1 and from 83.0±6.18 to 67.6±5.97 beats/min in the 2nd group, p 0.05). Comparison of changes in the studied parameters during the treatment did not reveal statistically significant differences between the groups. Replacement of drugs in each group after 4 weeks of therapy ensured the preservation of the achieved effect of treatment. No adverse events were recorded during the 8-week course of treatment in both groups. Conclusion . A pilot comparative study showed that the studied generic drug of ivabradine has a therapeutic effect comparable to the original drug, but studies with a larger number of patients are necessary.
Highlights
A statistically significant decrease in heart rate and in blood pressure level was found in groups during the first 4 weeks of follow-up
Сведения об авторах: Поветкин Сергей Владимирович – д.м.н., профессор, зав. кафедрой клинической фармакологии, Курский государственный медицинский университет Лунева Юлия Владимировна – к.м.н., доцент, кафедра клинической фармакологии, Курский государственный медицинский университет
Summary
В открытое рандомизированное пилотное исследование с перекрестным дизайном было включено 20 больных стабильной стенокардией напряжения II-III ФК. При включении пациентов в исследование оценивали также отсутствие у них противопоказаний к назначению ивабрадина. После завершения обследования пациентов рандомизировали в две группы приема препаратов ивабрадина. В 1-й группе дополнительно к получаемой терапии добавлялся оригинальный препарат ивабрадина (Кораксан®, Сервье; Сердикс, Россия) 5 мг 2 р/сут; у пациентов 2-й группы – дженерический препарат ивабрадина (Раеном®, Гедеон Рихтер, Венгрия) 5 мг 2 р/сут. В течение последующего месяца осуществляли еженедельный контроль за состоянием больных, при необходимости проводили коррекцию доз используемых антигипертензивных и антиангинальных препаратов для достижения целевых значений оцениваемых клинических показателей [1,2,3, 9, 10]. После 4-х нед терапии у больных 1-й группы проводили замену оригинального препарата ивабрадина на воспроизведенный в эквивалентных дозах, а во 2-й группе – наоборот, дальнейшее наблюдение проводили еще в течение 4-х нед Результаты (для абсолютных количественных параметров) представлены в виде M±SD; относительные показатели выражены в процентах
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