RESUMO
The antihypertensive efficacy, the hemodynamic effects and the tolerability of a new slow-release nicardipine (SR-Nic) formulation, capsules containing 40 mg of active drug, have been tested in a randomized, double-blind placebo (P)-controlled study. Thirty mild-to-moderate essential hypertensives were enrolled and after a one-week single-blind placebo run-in period randomly allocated to SR-Nic or P twice-day for six weeks. Blood pressure (BP) was measured after 1, 2, 4 and 6 weeks of treatment. Hemodynamic parameters were evaluated non-invasively by the impedance cardiography technique, using the Noninvasive Continuous Cardiac Output Monitor (NNCOM 3, BoMed Medical Manufacturing Ltd), after 2 and 4 weeks of treatment. All the determinations were made before the morning administration, i.e., 12-14 h after evening intake of SR-Nic or P. The blood pressure (p less than .01) and hemodynamic response (p less than .01 for the systemic vascular resistances) in the SR-Nic group significantly differed from those in the P group. At the end of the study, there were decreases in mean systolic/diastolic BP values of 17/12 in the sitting and of 18/12 mmHg in the standing position in the SR-Nic group; in the P group, the changes were +2/-2 in the sitting and +2/-1 mmHg in the standing position. Systemic vascular resistances were reduced by 17.3% in the SR-Nic and by 1.9% in the P group after 4 weeks of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)