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 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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