rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2010-6-1-20-28rpcardio-765Research ArticleORIGINAL STUDIESОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯCOMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISKСРАВНЕНИЕ НОВОГО ДЖЕНЕРИКА И ОРИГИНАЛЬНОГО ПРЕПАРАТА РАМИПРИЛА У БОЛЬНЫХ АРТЕРИАЛЬНОЙ ГИПЕРТОНИЕЙ И ВЫСОКИМ РИСКОМ СЕРДЕЧНО-СОСУДИСТЫХ ОСЛОЖНЕНИЙМарцевичС. Ю.MartsevichS. Yu.

101990 Москва, Петроверигский пер., 10

д.м.н., профессор, руководитель отдела профилактической фармакотерапии ГНИЦ ПМ, профессор кафедры доказательной медицины 

Petroverigsky per. 10, Moscow, 101990

Chair of Evidence Based Medicine

Bolshaya Pirogovskaya ul. 6, Moscow, 119991

ЛукинаЮ. В.LukinaYu. V.

101990 Москва, Петроверигский пер., 10

к.м.н., ст.н.с. отдела профилактической фармакотерапии ГНИЦ ПМ, ассистент кафедры доказательной медицины 

Petroverigsky per. 10, Moscow, 101990

Chair of Evidence Based Medicine

Bolshaya Pirogovskaya ul. 6, Moscow, 119991

jlukina@gnicpm.ruДмитриеваН. А.DmitrievaN. A.

101990 Москва, Петроверигский пер., 10

к.м.н., н.с. отдела профилактической фармакотерапии 

Petroverigsky per. 10, Moscow, 101990

ЛерманО. В.LermanO. V.

101990 Москва, Петроверигский пер., 10

к.м.н., ст.н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

ТолпыгинаС. Н.TolpyginaS. N.

101990 Москва, Петроверигский пер., 10

к.м.н., вед.н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

СеражимА. А.SerazhimA. A.

101990 Москва, Петроверигский пер., 10

к.м.н., н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

ВоронинаВ. П.VoroninaV. P.

101990 Москва, Петроверигский пер., 10

к.м.н., н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

МаксимоваМ. А.MaksimovaM. A.

101990 Москва, Петроверигский пер., 10

мл.н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

ДроздоваЛ. Ю.DrozdovaL. Yu.

101990 Москва, Петроверигский пер., 10

мл.н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

ЗахароваА. В.ZakharovaA. V.

101990 Москва, Петроверигский пер., 10

к.м.н., н.с. того же отдела

Petroverigsky per. 10, Moscow, 101990

Государственный научно-исследовательский центр профилактической медицины Росмедтехнологий, Московская медицинская академия им. И.М. СеченоваState Research Center for Preventive Medicine of Rosmedtechnology, Moscow Medical Academy named after I.M.SetchenovRussian FederationГосударственный научно-исследовательский центр профилактической медицины РосмедтехнологийРоссияState Research Center for Preventive Medicine of RosmedtechnologyRussian Federation201015012016612028Copyright © Martsevich S.Y., Lukina Y.V., Dmitrieva N.A., Lerman O.V., Tolpygina S.N., Serazhim A.A., Voronina V.P., Maksimova M.A., Drozdova L.Y., Zakharova A.V., 20162016Марцевич С.Ю., Лукина Ю.В., Дмитриева Н.А., Лерман О.В., Толпыгина С.Н., Серажим А.А., Воронина В.П., Максимова М.А., Дроздова Л.Ю., Захарова А.В.Martsevich S.Y., Lukina Y.V., Dmitrieva N.A., Lerman O.V., Tolpygina S.N., Serazhim A.A., Voronina V.P., Maksimova M.A., Drozdova L.Y., Zakharova A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/765Aim

Aim. To compare efficacy of ramipril generic Hartil® (Egis) to original drug Tritace® in patients with arterial hypertension (HT) of 1-2 degree and high cardiovascular risk, and to evaluate target blood pressure (BP) achievement when taking each drug separately and in combination with the calcium channel blocker amlodipine.

Material and methods

Material and methods. A total of 27 patients (14 men, 13 women) with HT of 1-2 degree and high risk due to combination of HT with ischemic heart disease, diabetes or previous stroke were included in an open randomized crossover study. Each patient received generic and original ramipril during 6 weeks by turns. Antihypertensive efficacy (the target BP level <130/80) was evaluated every 2 weeks. In case of treatment inefficiency a dose was doubled and amlodipine (Cardilopin, Egis) was added. After 6 weeks of treatment with the first drug of ramipril the second one was administered.

Results

Results. After 6-week Hartil treatment the mean systolic BP (sBP) decreased by 20,0 mm Hg compared to the baseline level, while at Tritace treatment – by 22,2 mm Hg. The mean diastolic BP (dBP) decreased by 10,8 and 8,6 mm Hg respectively (differences between the drugs were insignificant). Twenty patients treated with Hartil and 16 patients treated with Tritace required Cardilopin prescription. The target BP<130/80 was achieved in 10 patients (38,5%) who took Hartil and in 13 patients (50%) treated with the original ramipril (differences between the drugs were insignificant).

Conclusion

Conclusion. Therapeutic equivalence of the generic ramipril Hartil and the original drug Tritace was demonstrated. Monotherapy efficacy was low in high-risk patients with HT of 1-2 degree, and combined therapy with two antihypertensive drugs was effective in 40-50% of cases.

Цель

Цель. Сравнить эффективность дженерического препарата рамиприла Хартил® (Эгис) и оригинального препарата Тритаце® у больных артериальной гипертонией (АГ) 1-2-й степени с высоким сердечно-сосудистым риском и изучить возможность достижения целевого уровня артериального давления (АД) при отдельном приеме каждого препарата и в комбинации с антагонистом кальциевых каналов амлодипином.

Материал и методы

Материал и методы. В открытое, рандомизированное, перекрестное исследование включены 27 пациентов (14 мужчин и 13 женщин) с АГ 1-2-й степени с высоким риском, обусловленным сочетанием АГ с ишемической болезнью сердца, сахарным диабетом, мозговым инсультом (в анамнезе). Каждый пациент поочередно получал в течение 6 недель дженерический и оригинальный препарат рамиприла. Антигипертензивная эффективность (целевой уровень АД <130/80 мм рт.ст.) оценивалась каждые 2 недели. При неэффективности терапии дозу удваивали и добавляли амлодипин (Кардилопин, Эгис). Через 6 недель лечения первым препаратом проводили лечение вторым препаратом рамиприла.

Результаты

Результаты. В результате 6-недельного лечения Хартилом средний уровень систолического АД (САД) снизился на 20,0 мм рт.ст. по сравнению с исходным, после 6-недельной терапии Тритаце — на 22,2 мм рт.ст. Средний уровень диастолического АД (ДАД) снизился на 10,8 и 8,6 мм рт.ст., соответственно (различия между препаратами незначимы). Назначение Кардилопина потребовалось 20 пациентам при лечении Хартилом и 16 — при терапии Тритаце. Достичь целевого уровня АД <130/80 мм рт.ст. удалось у 10 больных (38,5%) при лечении Хартилом и у 13 больных (50%) при использовании оригинального рамиприла (различия между препаратами незначимы).

Заключение

Заключение. Показана терапевтическая эквивалентность дженерического препарата рамиприла Хартила и оригинального препарата рамиприла Тритаце. У пациентов с АГ 1-2-й степени с высоким риском выявлена низкая эффективность монотерапии, а комбинированная терапия двумя антигипертензивными препаратами эффективна в 40-50% случаев.

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The authors declare that there are no conflicts of interest present.