EVALUATION OF TRANDOLAPRIL ALONE OR IN CO MBINATION WITH A CALCIUM-CHANNEL BLOCKER IN HYPERTENSIVE PATIENTS OVER 60 YEARS OLD

The efficacy and safety of trandolapril alone and in combination with a calcium channel blocker were evaluated in 13,147 hypertensive patien ts over 60 years old. Two patient groups were constituted. After a 2-w eek wash-out period, the patients in group I received monotherapy with trandolapril 2 mg/day for 4 weeks. Trandolapril was continued for ano ther 4 weeks in responding patient, otherwise the dosage of trandolapr il was doubled or another antihypertensive was added. Group 2, compose d of patients previously treated with a calcium channel blocker with i nsufficient efficacy, was treated according to the same treatment regi men, but the calcium channel blocker was maintained throughout the stu dy. 13,147 patients (group 1 : 11,329 patients, group 2. 1,818 patient s) with a mean age of 68 +/- 7 years were followed. After 4 weeks of t reatment, the blood pressure measured by mercury sphygmomanometer decr eased from 176+ 11/99+/-8 mmHg to 164+/-12/87+/-7 mmHg (p < 0.0001). T his blood pressure fail was similar in group 1 (-22+/-12/-12+/-8 mmHg) and in group 2 (-21+/-11/-12+/-8 mmHg). In the pure systolic HT subgr oup treated by trandolapril monotherapy, the antihypertensive effect p redominantly affected the SEP (-23+/-12/-4 +/-6 mmHg). The antihyperte nsive effect was correlated with the initial blood pressure. In group 1, in the case of insufficient response to trandolapril monotherapy, t he addition of a calcium channel blocker was the strategy which achiev ed the most marked antihypertensive effect (ANOVA, p<0.0001). This bit herapy was more effective than the trandolapril + diuretic combination (-18+/-11/-11+/-8 mmHg and -15+/-10/-9+/-7 mmHg, respectively (p < 0. 001). A total of 1,270 adverse events were reported by 996 patients (7 .6%), leading to discontinuation of treatment in 372 patients (2.8 %). The most frequent adverse effects were cough (2.8 %), headache (0.8 % ), vertigo (0.8 %) and nausea (0.5 %). Only one minor equivalent of an gioneurotic oedema was reported. In conclusion, trandolapril is effect ive and well tolerated in elderly hypertensive patients. In the case o f pure systolic HTA, its action is essentially exerted on SEP. The com bination of trandolapril + calcium channel blocker appears to be the m ost effective strategy in the case of incomplete blood pressure contro l by trandolapril alone.