T McINNES G, Istad H, Keinänen-Kiukaanniemi S, VAN Mierlo H F C M
a University Department of Medicine and Therapeutics, Western Infirmary, Glasgow, UK.
b Theresegt. Legecenter, Oslo, Norway.
Blood Press. 2000;9(sup1):61. doi: 10.1080/080370500439344.
Monotherapy with an antihypertensive agent is likely to achieve a desirable lowering of blood pressure in about 50% of patients. The remaining proportion of patients are likely to be only partially responsive or unresponsive, even if appropriate dose adjustments are made. For these patients, combination therapy usually leads to better control of hypertension. The aim of this study was to compare the antihypertensive effect and tolerability of a once-daily combination of the angiotensin II type 1 (AT 1 ) receptor blocker candesartan cilexetil, 8 mg, and the diuretic hydrochlorothiazide (HCTZ), 12.5 mg, with a combination of the angiotensin-converting enzyme inhibitor, lisinopril, 10 mg, and HCTZ, 12.5 mg, in patients with primary hypertension. The study included men and women, 20-80 years of age, with sitting diastolic blood pressure (DBP) of 95-114 mm Hg. After a run-in period of 2 weeks on any antihypertensive monotherapy, 355 patients were randomized to double-blind treatment with either a combination of candesartan cilexetil/HCTZ, 8/12.5 mg, or a combination of lisinopril/HCTZ, 10/12.5 mg, for 26 weeks. Blood pressure was measured 24 h after dose intake, the primary efficacy variable being the change in sitting DBP at trough between baseline and 26 weeks of treatment. Reductions in mean sitting DBP after 26 weeks were similar for both combination treatments. In addition, no differences were found between the two treatment groups regarding standing DBP, sitting and standing systolic blood pressure, heart rate, and the proportion of responders and controlled patients. Significantly fewer patients reported at least one adverse event with candesartan cilexetil/HCTZ than with lisinopril/HCTZ (68.9% vs 79.5%, p = 0.02; see Table). Furthermore, the proportion of patients spontaneously reporting cough was markedly higher in the lisinopril/HCTZ group (23.9%) than in the candesartan cilexetil/HCTZ group (5.0%). Thus, although the combinations of candesartan cilexetil/HCTZ, 8/12.5 mg once daily, and lisinopril/HCTZ, 10/12.5 mg once daily, had similar antihypertensive efficacy in patients with mild to moderate hypertension during the 26-week treatment period, candesartan cilexetil/HCTZ was significantly better tolerated than lisinopril/HCTZ.
使用一种抗高血压药物进行单药治疗，大约50%的患者可能会实现理想的血压降低。即使进行了适当的剂量调整，其余患者可能仅部分有反应或无反应。对于这些患者，联合治疗通常能更好地控制高血压。本研究的目的是比较1型血管紧张素II（AT1）受体阻滞剂坎地沙坦酯8毫克与利尿剂氢氯噻嗪（HCTZ）12.5毫克每日一次联合用药，与血管紧张素转换酶抑制剂赖诺普利10毫克和HCTZ 12.5毫克联合用药，在原发性高血压患者中的降压效果和耐受性。该研究纳入了年龄在20至80岁之间、坐位舒张压（DBP）为95至114毫米汞柱的男性和女性。在接受任何抗高血压单药治疗2周的导入期后，355例患者被随机分为双盲治疗组，分别接受坎地沙坦酯/HCTZ 8/12.5毫克联合用药或赖诺普利/HCTZ 10/12.5毫克联合用药，为期26周。在服药24小时后测量血压，主要疗效变量是治疗26周时基线与谷值时坐位DBP的变化。两种联合治疗在26周后平均坐位DBP的降低相似。此外，在站立位DBP、坐位和站立位收缩压、心率以及有反应者和血压得到控制的患者比例方面，两个治疗组之间未发现差异。报告至少一种不良事件的患者，使用坎地沙坦酯/HCTZ的明显少于使用赖诺普利/HCTZ的（68.9%对79.5%，p = 0.02；见表）。此外，自发报告咳嗽的患者比例在赖诺普利/HCTZ组（23.9%）明显高于坎地沙坦酯/HCTZ组（5.0%）。因此，尽管在26周的治疗期内，每日一次8/12.5毫克的坎地沙坦酯/HCTZ联合用药和每日一次10/12.5毫克的赖诺普利/HCTZ联合用药在轻度至中度高血压患者中具有相似的降压疗效，但坎地沙坦酯/HCTZ的耐受性明显优于赖诺普利/HCTZ。
