McInnes G T, O'Kane K P, Jonker J, Roth J
University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, UK.
J Hum Hypertens. 1997 Sep;11 Suppl 2:S75-80.
This study was performed to evaluate the antihypertensive efficacy and tolerability of candesartan cilexetil 8-16 mg once-daily in comparison with placebo in elderly hypertensive patients. Forty-one hospital and general practice centres in the Netherlands and in the United Kingdom enrolled 350 patients over 65 years of age with essential hypertension (WHO grades I or II). Patients with supine diastolic BP in the range 95-114 mm Hg after 4- to 8-week placebo run-in period (n = 193) were randomised to double-blind therapy with candesartan cilexetil or placebo. The initial dose of candesartan cilexetil 8 mg or placebo was doubled after 6 weeks if supine diastolic blood pressure (BP) exceeded 90 mm Hg. Mean (95% confidence interval) placebo-corrected reduction in supine diastolic BP after 12 weeks' treatment with candesartan cilexetil was 7.5 mm Hg (3.6-11.4; P < 0.001); the corresponding reduction in supine systolic BP was 13.6 mm Hg (6.9-20.2; P < 0.001). Placebo-corrected mean reduction in supine diastolic BP 2 and 4 h after the first dose of candesartan cilexetil were 2.2 mm Hg (-1.3 to +5.8; P = 0.219) and 4.0 mm Hg (-0.4 to +7.6; P = 0.027), respectively. Candesartan cilexetil had almost no influence on heart rate and did not affect the normal orthostatic changes in BP. Adverse events were equally common in the two treatment groups. Candesartan cilexetil 8-16 mg once-daily is an effective antihypertensive agent in elderly patients. The onset of action is smooth with no exaggerated response after the first dose and there is no postural hypotension. Candesartan cilexetil is very well tolerated in elderly hypertensives.
本研究旨在评估坎地沙坦酯8 - 16毫克每日一次相对于安慰剂在老年高血压患者中的降压疗效和耐受性。荷兰和英国的41家医院及全科医疗中心招募了350名65岁以上的原发性高血压患者(世界卫生组织分级为I级或II级)。在经过4至8周的安慰剂导入期后,仰卧位舒张压在95 - 114毫米汞柱范围内的患者(n = 193)被随机分配接受坎地沙坦酯或安慰剂的双盲治疗。如果仰卧位舒张压超过90毫米汞柱,6周后坎地沙坦酯8毫克或安慰剂的初始剂量加倍。用坎地沙坦酯治疗12周后,仰卧位舒张压的平均(95%置信区间)安慰剂校正降低值为7.5毫米汞柱(3.6 - 11.4;P < 0.001);仰卧位收缩压的相应降低值为13.6毫米汞柱(6.9 - 20.2;P < 0.001)。首次服用坎地沙坦酯后2小时和4小时仰卧位舒张压的安慰剂校正平均降低值分别为2.2毫米汞柱(-1.3至+5.8;P = 0.219)和4.0毫米汞柱(-0.4至+7.6;P = 0.027)。坎地沙坦酯对心率几乎没有影响,也不影响血压正常的体位变化。两个治疗组的不良事件发生率相当。坎地沙坦酯8 - 16毫克每日一次是老年患者有效的抗高血压药物。起效平稳,首剂后无过度反应,且无体位性低血压。坎地沙坦酯在老年高血压患者中耐受性良好。