Gosse P, Vaur L, Dutrey-Dupagne C, Genes N, Destrée D, Elkik F
Service du Pr Clementy, Hôpital St-André, Bordeaux.
Ann Cardiol Angeiol (Paris). 1995 Nov;44(9):517-24.
The efficacy and safety of trandolapril alone and in combination with a calcium channel blocker were evaluated in 13,147 hypertensive patients over 60 years old. Two patient groups were constituted. After a 2-week wash-out period, the patients in group I received monotherapy with trandolapril 2 mg/day for 4 weeks. Trandolapril was continued for another 4 weeks in responding patient, otherwise the dosage of trandolapril was doubled or another antihypertensive was added. Group 2, composed of patients previously treated with a calcium channel blocker with insufficient efficacy, was treated according to the same treatment regimen, but the calcium channel blocker was maintained throughout the study. 13,147 patients (group 1: 11,329 patients, group 2: 1,818 patients) with a mean age of 68 +/- 7 years were followed. After 4 weeks of treatment, the blood pressure measured by mercury sphygmomanometer decreased from 176 + 11/99 +/- 8 mmHg to 164 +/- 12/87 +/- 7 mmHg (p < 0.0001). This blood pressure fall was similar in group 1 (-22 +/- 12/-12 +/- 8 mmHg) and in group 2 (-21 +/- 11/-12 +/- 8 mmHg). In the pure systolic HT subgroup treated by trandolapril monotherapy, the antihypertensive effect predominantly affected the SBP (-23 +/- 12/- 4 +/- 6 mmHg). The antihypertensive effect was correlated with the initial blood pressure. In group 1, in the case of insufficient response to trandolapril monotherapy, the addition of a calcium channel blocker was the strategy which achieved the most marked antihypertensive effect (ANOVA, p < 0.0001). This bitherapy 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 angioneurotic oedema was reported. In conclusion, trandolapril is effective and well tolerated in elderly hypertensive patients. In the case of pure systolic HTA, its action is essentially exerted on SBP. The combination of trandolapril+calcium channel blocker appears to be the most effective strategy in the case of incomplete blood pressure control by trandolapril alone.
对13147名60岁以上的高血压患者评估了群多普利单药治疗及其与钙通道阻滞剂联合治疗的疗效和安全性。将患者分为两组。经过2周的洗脱期后，第一组患者接受群多普利2毫克/天的单药治疗，为期4周。血压有反应的患者继续服用群多普利4周，否则群多普利剂量加倍或加用另一种抗高血压药物。第二组由先前使用钙通道阻滞剂但疗效不佳的患者组成，按照相同的治疗方案进行治疗，但在整个研究过程中持续使用钙通道阻滞剂。对平均年龄为68±7岁的13147名患者（第一组：11329名患者，第二组：1818名患者）进行了随访。治疗4周后，用汞柱式血压计测量的血压从176±11/99±8毫米汞柱降至164±12/87±7毫米汞柱（p<0.0001）。第一组（-22±12/-12±8毫米汞柱）和第二组（-21±11/-12±8毫米汞柱）的血压下降情况相似。在接受群多普利单药治疗的单纯收缩期高血压亚组中，降压作用主要影响收缩压（-23±12/-4±6毫米汞柱）。降压效果与初始血压相关。在第一组中，若群多普利单药治疗反应不足，加用钙通道阻滞剂是实现最显著降压效果的策略（方差分析，p<0.0001）。这种联合治疗比群多普利+利尿剂联合治疗更有效（分别为-18±11/-11±8毫米汞柱和-15±10/-9±7毫米汞柱，p<0.001）。996名患者（7.6%）共报告了1270起不良事件，导致372名患者（2.8%）停药。最常见的不良反应为咳嗽（2.8%）、头痛（0.8%）、眩晕（0.8%）和恶心（0.5%）。仅报告了1例轻度类血管性水肿。总之，群多普利在老年高血压患者中有效且耐受性良好。在单纯收缩期高血压的情况下，其作用主要作用于收缩压。在群多普利单药治疗血压控制不完全的情况下，群多普利+钙通道阻滞剂联合治疗似乎是最有效的策略。
