Clinical experience with long-term nitrendipine treatment in essential hypertension.

Fifty-one patients with essential hypertension, 22 males and 29 females with a mean age of 51 (range, 28 to 65 years), were studied for more than 12 months in a controlled clinical trial with nitrendipine, a new calcium antagonist agent. No differences in age, severity of hypertension, and other risk factors between the two sexes were detected. Forty-four of 51 patients completed the study, and 38 (86.4%) achieved a normalization of blood pressure. Mean systolic blood pressure decreased from 196.0 +/- 12.9 mm Hg (means +/- SD) during placebo to 171.2 +/- 9.5 mm Hg (12.6%, p less than 0.001) after 12 months. Mean diastolic blood pressure at the same time decreased from 109.0 +/- 5.2 mm Hg to 88.5 +/- 3.6 mm Hg (18.8%, p less than 0.001). Heart rate also decreased slightly but significantly (p less than 0.01) after the fifth week. A significant change in weight was not observed throughout the trial. Plasma potassium remained unchanged during the year, and plasma sodium after a transient increase (p less than 0.001) in the fifth week returned very close to basal levels in the sixth month. Side-effects were observed in 17 patients, 5 of whom had to leave the trial, but in the rest they were usually mild and transient. These were mainly frontal and occipital headache, facial flushing, ankle and pretibial oedema, and dizziness. No relationship was detected between side-effects and body weight or plasma sodium disturbances. Preliminary data on a separate group of 27 elderly patients (66-83 years) showed a better and faster effect of nitrendipine given in low doses.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes