ANTIHYPERTENSIVE EFFECTS OF TRANDOLAPRIL AND NITRENDIPINE IN THE ELDERLY - A CONTROLLED TRIAL WITH SPECIAL EMPHASIS ON TIME EFFECT PROFILES

The aim of this double-blind randomized study was to compare the antih ypertensive effects of trandolapril and nitrendipine in the elderly. A fter a 2-week placebo period, patients received either trandolapril 0. 5 mg or nitrendipine 10 mg, once daily for 15 days. At the end of this period, according to a forced titration, the dose was 11 increased to 2 mg of trandolapril or 20 mg of nitrendipine once daily for 2 months . Seventy-three hypertensive patients, aged 65 and over, entered the s tudy. Demographic data and initial blood pressure (BP) level were comp arable in the two groups. The antihypertensive effect, measured with a mercury sphygmomanometer, was assessed in 64 patients: SBP decreased by 18.6 +/- 12.1 mm Hg in the trandolapril (P < 0.001) and by 21.0 +/- 13.7 mm Hg in the nitrendipine group (P < 0.001); DBP decreased by 13 .4 +/- 8.2 mm Hg in the trandolapril group (P < 0.001) and by 15.4 +/- 8.2 mm Hg in the nitrendipine group (P < 0.001). No statistically sig nificant difference was seen between the two treatment groups. A subgr oup of 42 patients were evaluated by 24 h ambulatory BP monitoring. Me an 24 h ambulatory SBP/DBP decreases were 6.6 +/- 18.0/8.4 +/- 8.5 mm Hg in the trandolapril group (P<0.001) and 5.7 +/- 11.1/7.2 +/- 9.6 mm Hg in the nitrendipine group (P < 0.001). The differences between the two treatment groups were not statistically significant. The antihype rtensive action of trandolapril was sustained throughout the 24 h peri od with a trough-to-peak ratio of 70.2% for SBP and 70.9% for DBP. Nit rendipine exerted its action mainly during the day, with a very modest antihypertensive effect during the night and early morning; its troug h/peak ratio was 25.9% for SBP and 28% for DBP. The tolerance of both treatments were good; seven patients were withdrawn from the trial for adverse events (four in the nitrendipine group, three in the trandola pril group).