RESUMO
AIM: To estimate effectiveness and safety of losartan and its combination with amlodipine in therapy of arterial hypertension. MATERIALS AND METHODS: The study based at 6 clinical centres was conducted in two stages. All 160 patients with grade I-II AH (103 women and 57 men aged 54 ± 12 yr) participated in stage 1 of the study and patients of centre No 1 (n = 100) in stage 2. Losartan was used at a dose of 50-100 mg/24 h for 8 weeks (stage 1) and thereafter from week 9 to 26 (stage 2) in combination with amlodipine (5-10 mg/24 hr) if the desired AP level (< 140/90 mmHg) was not achieved. The following parameters were measured: systolic and diastolic AP (SAP and DAP) (office measurement and 24-hr monitoring), pulse wave propagation rate (PWPR), left ventricle mass index (LVMI), thickness of intima-media complex (IMT), blood biochemistry, tolerability of therapy and its side effects. RESULTS: Losartan alone decreased SAP and DAP from 150 ± 11/91 ± 7 to 132 ± 12/81 ± 8 mm Hg (office measurement) and from 144 ± 10/86 ± 9 to 128 ± 12/76 ± 10 mm Hg (24-hr monitoring); heart rate decreased fom 74 ± 8 to 70 ± 8/min (p < 0.05). SAP and DAP in 66 patients who completed stage 2 was 122 ± 6/73 ± 6 mm Hg or significantly lower than before therapy (147 ± 9/87 ± 9) (p < 0.001). Mean daily decrease of SAP and DAP according to 24-hr monitoring decreased from 144 ± 10 to 128 ± 12 and from 86 ± 9 to 76 ± 10 mm Hg respectively (p < 0.001). The target AP value was reached in 73% of the cases (99 out of 136 patients) after stage 1 and in 95% cases (63 out of 66) after stage 2. The values of LVMI (105 ± 23 and 98 ± 26 g/m2), PWPR from 16 ± 2.1 to 13 ± 3.5 m/s (p < 0.05), IMT (0.76 ± 0.16 and 0.80 ± 42 mm), and microalbuminuria (11.0 ± 1.7 and 8.6 ± 0.7 mg/24 hr) before and after completion of stage 2 were not significantly different in 66 patients (p > 0.05). Biochemical parameters of blood did not appreciably change. The safety profiles of both drugs were on the whole positive. Deaths and adverse reactions were absent barring clinically insignificant side effects in 28 of the 160 patients (17.5%). CONCLUSION: Losartan and amlodipine are effective and safe agents for AH therapy.