Vol 8, No 4 (2004)
Original paper
Published online: 2004-07-22

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Hypotensive efficacy and safety of eprosartan treatment - an open-label, multi-center clinical study

Maciej Janiszewski, Marek Chmielewski, Mirosław Dłużniewski, Marek Kuch, Artur Mamcarz
Nadciśnienie tętnicze 2004;8(4):255-262.

Abstract

Background Effective treatment of hypertension remains a major problem in modern cardiology. Despite constant advances in pharmacotherapy there is an urgent need for pharmacological agents combining hypotensive efficacy with high safety profile and good tolerance. Angiotensin II receptor antagonists fulfill these criteria.
The purpose of the study was to evaluate the efficacy, safety and tolerance of eprosartan treatment in patients with mild or moderate arterial hypertension.
Material and methods 564 patients with newly diagnosed or not effectively treated hypertension were enrolled into the study. The patients received eprosartan 600 mg/daily. The efficacy and safety of the treatment was assessed after 4 and 12 weeks of therapy.
Results Twelve weeks of eprosartan treatment resulted in the reduction of both systolic and diastolic blood pressure by 26.1 mm Hg and 12.6 mm Hg respectively (p < 0.001). Significant decrease of the resting heart rate was also observed. During 3 months of eprosartan treatment there were no significant changes of electrolyte and glucose concentrations and renal function parameters. Improvement of lipid profile was observed. Adverse events were rare and of mild (8.7%). The most common side effects included headache, dizziness, nausea and weakness. After 12 weeks of treatment in 91.5% of patients the treatment tolerance was assessed as very good or good.
Conclusions Eprosartan is an effective hypotensive agent; achieved blood pressure values confirm that it is a potent hypotensive agent.
Eprosartan reduces mean resting heart rate.
Eprosartan is metabolically safe (favourably influences blood lipids, no effect on glucose concentration, kaliuresis and renal parameters was observed).
Adverse events associated with eprosartan treatment in the dose of 600 mg/day are relatively rare and most commonly mild. No serious adverse events associated with the study drug were observed.

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