Hansson L, Hedner T, Lund-Johansen P, Kjeldsen S E, Lindholm L H, Syvertsen J O, Lanke J, de Faire U, Dahlöf B, Karlberg B E
Department of Public Health and Social Sciences, University of Uppsala, Sweden.
Lancet. 2000 Jul 29;356(9227):359-65. doi: 10.1016/s0140-6736(00)02526-5.
Calcium antagonists are a first-line treatment for hypertension. The effectiveness of diltiazem, a non-dihydropyridine calcium antagonist, in reducing cardiovascular morbidity or mortality is unclear. We compared the effects of diltiazem with that of diuretics, beta-blockers, or both on cardiovascular morbidity and mortality in hypertensive patients.
In a prospective, randomised, open, blinded endpoint study, we enrolled 10,881 patients, aged 50-74 years, at health centres in Norway and Sweden, who had diastolic blood pressure of 100 mm Hg or more. We randomly assigned patients diltiazem, or diuretics, beta-blockers, or both. The combined primary endpoint was fatal and non-fatal stroke, myocardial infarction, and other cardiovascular death. Analysis was done by intention to treat.
Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups (reduction 20.3/18.7 vs 23.3/18.7 mm Hg; difference in systolic reduction p<0.001). A primary endpoint occurred in 403 patients in the diltiazem group and in 400 in the diuretic and beta-blocker group (16.6 vs 16.2 events per 1000 patient-years; relative risk 1.00 [95% CI 0.87-1.15], p=0.97). Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group (6.4 vs 7.9 events per 1000 patient-years; 0.80 [0.65-0.99], p=0.04) and fatal and non-fatal myocardial infarction in 183 and 157 patients (7.4 vs 6.3 events per 1000 patient-years; 1.16 [0.94-1.44], p=0.17).
Diltiazem was as effective as treatment based on diuretics, beta-blockers, or both in preventing the combined primary endpoint of all stroke, myocardial infarction, and other cardiovascular death.
钙拮抗剂是高血压的一线治疗药物。非二氢吡啶类钙拮抗剂地尔硫䓬在降低心血管疾病发病率或死亡率方面的有效性尚不清楚。我们比较了地尔硫䓬与利尿剂、β受体阻滞剂或两者联合使用对高血压患者心血管疾病发病率和死亡率的影响。
在一项前瞻性、随机、开放、盲终点研究中，我们纳入了挪威和瑞典健康中心的10881名年龄在50 - 74岁之间、舒张压为100 mmHg或更高的患者。我们将患者随机分配接受地尔硫䓬、利尿剂、β受体阻滞剂或两者联合治疗。联合主要终点是致命性和非致命性中风、心肌梗死及其他心血管死亡。分析采用意向性治疗。
地尔硫䓬组以及利尿剂和β受体阻滞剂组的收缩压和舒张压均有效降低（收缩压降低幅度分别为20.3/18.7 mmHg和23.3/18.7 mmHg；收缩压降低差异p<0.001）。地尔硫䓬组403例患者发生主要终点事件，利尿剂和β受体阻滞剂组400例（每1000患者年事件数分别为16.6和16.2；相对风险1.00 [95%CI 0.87 - 1.15]，p = 0.97）。地尔硫䓬组159例患者发生致命性和非致命性中风，利尿剂和β受体阻滞剂组196例（每1000患者年事件数分别为6.4和7.9；0.80 [0.65 - 0.99]，p = 0.04），183例和157例患者发生致命性和非致命性心肌梗死（每1000患者年事件数分别为7.4和6.3；1.16 [0.94 - 1.44]，p = 0.17）。
在预防所有中风、心肌梗死及其他心血管死亡的联合主要终点方面，地尔硫䓬与基于利尿剂、β受体阻滞剂或两者联合的治疗效果相当。
