Антигипертензивная, нефропротективная и кардиопротективная эффективность блокатора АТ1-рецепторов ангиотензина II валсартана в средней терапевтической и максимальной суточной дозах по сравнению с ингибитором ангиотензинпревращающего фермента эналаприла у

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Abstract

The purpose of the open non-randomized clinical study of therapeutic efficacy and safety of the valsartan in patients with chronic kidney disease (CKD) and hypertension II-III degree was to evaluate the antihypertensive, nephroprotective and cardioprotective efficacy, tolerance and safety of valsartan in therapeutic medium and high doses compared with angiotensin-converting enzyme (ACE) inhibitor enalapril. The study included 124 patients 45-70 years with serum creatinine more than 0.15 mmol/l, systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >95 mm Hg, microalbuminuria 30-300 mg/day. Time of observation - 16 weeks. Patients were randomized into 4 groups: 1st group (39 patients) valsartan at a dose of 160 mg 1 time a day, the 2nd group (28 patients) - valsartan at a dose of 320 mg/day for 2 doses, the 3rd group (33 patients) - enalapril 20 mg 1 time per day, 4th (24 patients) - enalapril 40 mg daily for 2 doses. Investigated parameters: reduction of blood pressure (BP), the daily microalbuminuria, left ventricular mass index (LVMI), safety and tolerability of therapy. According to BP monitoring (ABPM) in all groups the decrease of SBP (12,6±1,2, 18,2±1,5, 10,1±1,0, 14,4±1,3 mm Hg respectively) and DBP (8,5±0,6, 10,9±1,1, 6,7±0,4, 8,2±0,7 mm Hg respectively) was valid (p<0,05). Ander the analysis of SBP and DBP valued differences were detected between groups: the 1st and 2nd, 3rd and 4th, 1st and 3rd, 2nd and 4th. Microalbuminuria was decreasing positively (p<0.05) in all 4 groups (25,4, 41,2, 24,7, 37,5% respectively). There were valid differences in the reduction of microalbuminuria between groups first and the second, third and fourth. LVMI was significantly (p<0,05) decreased in all 4 groups (8,4, 14,9, 8,1, 12,3% respectively). There were no reliable changes noted. Valsartan and enalapril (in doses of 160 and 320, 20 and 40 mg respectively) were been positively reducing the average daily SBP and DBP according to ABPM among the patients with CKD and hypertension II-III degree after 16 weeks of treatment. Antihypertensive effect of both drugs was dose-dependent. Antihypertensive effect of valsartan was validly excelled relative parameter of enalapril in equivalent doses. Valsartan and enalapril in the doses noted validly and equally reduced for equivalent doses the microalbuminuria, the effect of both drugs was dosedependent. Valsartan and enalapril were equally effective and significantly reduced LVMI. The influence of both drugs on regression of LVMI was not doze-depended. Valsartan therapy in doses of 160 and 320 mg was well tolerated; side effects were found in 3% of cases and did not require dose reduction or cancellation of the drug.

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Chief Editor

Leo A. Bockeria, MD, PhD, DSc, Professor, Academician of Russian Academy of Sciences, Director of Bakoulev National Medical Research Center for Cardiovascular Surgery