COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK

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 ch...

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Main Authors: S. Yu. Martsevich, Yu. V. Lukina, N. A. Dmitrieva, O. V. Lerman, S. N. Tolpygina, A. A. Serazhim, V. P. Voronina, M. A. Maksimova, L. Yu. Drozdova, A. V. Zakharova
Format: Article
Language:English
Published: Столичная издательская компания 2016-01-01
Series:Рациональная фармакотерапия в кардиологии
Subjects:
Online Access:https://www.rpcardio.online/jour/article/view/765
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author S. Yu. Martsevich
Yu. V. Lukina
N. A. Dmitrieva
O. V. Lerman
S. N. Tolpygina
A. A. Serazhim
V. P. Voronina
M. A. Maksimova
L. Yu. Drozdova
A. V. Zakharova
author_facet S. Yu. Martsevich
Yu. V. Lukina
N. A. Dmitrieva
O. V. Lerman
S. N. Tolpygina
A. A. Serazhim
V. P. Voronina
M. A. Maksimova
L. Yu. Drozdova
A. V. Zakharova
author_sort S. Yu. Martsevich
collection DOAJ
description 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. 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. 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. 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.
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spelling doaj.art-79d76954de2b4dfe88059012eba4cabe2024-04-01T07:43:28ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532016-01-0161202810.20996/1819-6446-2010-6-1-20-28764COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISKS. Yu. Martsevich0Yu. V. Lukina1N. A. Dmitrieva2O. V. Lerman3S. N. Tolpygina4A. A. Serazhim5V. P. Voronina6M. A. Maksimova7L. Yu. Drozdova8A. V. Zakharova9State Research Center for Preventive Medicine of Rosmedtechnology, Moscow Medical Academy named after I.M.SetchenovState Research Center for Preventive Medicine of Rosmedtechnology, Moscow Medical Academy named after I.M.SetchenovState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyState Research Center for Preventive Medicine of RosmedtechnologyAim. 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. 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. 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. 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.https://www.rpcardio.online/jour/article/view/765arterial hypertensiongeneric drugramipril
spellingShingle S. Yu. Martsevich
Yu. V. Lukina
N. A. Dmitrieva
O. V. Lerman
S. N. Tolpygina
A. A. Serazhim
V. P. Voronina
M. A. Maksimova
L. Yu. Drozdova
A. V. Zakharova
COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
Рациональная фармакотерапия в кардиологии
arterial hypertension
generic drug
ramipril
title COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
title_full COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
title_fullStr COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
title_full_unstemmed COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
title_short COMPARISON OF NEW GENERIC AND ORIGINAL RAMIPRIL IN PATIENTS WITH ARTERIAL HYPERTENSION AND HIGH CARDIOVASCULAR RISK
title_sort comparison of new generic and original ramipril in patients with arterial hypertension and high cardiovascular risk
topic arterial hypertension
generic drug
ramipril
url https://www.rpcardio.online/jour/article/view/765
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