Byyny R L, Merrill D D, Bradstreet T E, Sweet C S
University of Colorado Health Sciences Center, Denver, CO, USA.
Cardiovasc Drugs Ther. 1996 Jul;10(3):313-9. doi: 10.1007/BF02627955.
The antihypertensive activity and safety of losartan, a specific and selective antagonist of angiotensin II (subtype 1) receptors, was evaluated in 100 inpatients with mild to moderate essential hypertension. After a 2-week, single-blind, out patient placebo lead-in period, the last 2 days of which included inpatient monitoring of baseline blood pressure, the patients were assigned randomly to receive once-daily doses of either placebo; 50, 100, or 150 mg losartan; or 10 mg enalapril. Patients were treated double blind for 5 days, followed by a day for the study of drug withdrawal. Beginning with the first dose, the three doses of losartan and enalapril significantly decreased peak and trough systolic and diastolic blood pressures compared with placebo (p < or = 0.05). The area under the blood pressure curve was analyzed as an assessment of total blood pressure change throughout the day. On day 1, total blood pressure reduction with losartan (50-150 mg) was slightly less than with enalapril. By day 5 of double-blind treatment, the reduction in blood pressure in these groups was similar, suggesting that losartan has a slower onset of action than enalapril. No rebound hypertension was observed after study-drug discontinuation. Losartan was well tolerated in this trial, with an adverse event profile similar to placebo and enalapril.
对100例轻至中度原发性高血压住院患者评估了氯沙坦（一种特异性和选择性血管紧张素II（1型）受体拮抗剂）的降压活性和安全性。在为期2周的单盲门诊安慰剂导入期后（该导入期的最后2天包括对基线血压的住院监测），患者被随机分配接受每日一次的安慰剂、50、100或150mg氯沙坦或10mg依那普利治疗。患者接受双盲治疗5天，随后有1天用于研究撤药情况。从第一剂开始，与安慰剂相比，三剂氯沙坦和依那普利均显著降低了收缩压和舒张压的峰值和谷值（p≤0.05）。分析血压曲线下面积以评估全天的总血压变化。在第1天，氯沙坦（50 - 150mg）的总血压降低幅度略小于依那普利。到双盲治疗的第5天，这些组的血压降低情况相似，表明氯沙坦的起效比依那普利慢。在研究药物停用后未观察到反弹性高血压。氯沙坦在该试验中耐受性良好，不良事件情况与安慰剂和依那普利相似。
