Neutel Joel M, Germino F Wilford, Smith David
Orange County Research Center, Tustin, CA 92780, USA.
J Renin Angiotensin Aldosterone Syst. 2005 Sep;6(2):84-9. doi: 10.3317/jraas.2005.014.
The primary objective of this study was to compare the antihypertensive efficacy of the angiotensin II receptor blocker irbesartan 150 mg and the calcium channel blocker amlodipine 5 mg in the treatment of patients with seated diastolic blood pressure (DBP) 95-110 mmHg.
Multicentre, randomised, double-blind, comparative pilot study.
Subjects were 18-65 years of age, with DBP 95-110 mmHg, and of non-African American origin. Following a three week, single-blind, placebo lead-in period, 181 subjects were randomised in a 1:1 ratio to receive once-daily irbesartan 150 mg (n=89) or amlodipine 5 mg (n=92) for four weeks. Trough (24+/-3 hours post-dosing) BP measurements were obtained at baseline and at Weeks 2 and 4 under standardised, controlled conditions. Response was defined as DBP <90 mmHg or a reduction from baseline of 10 mmHg.
After four weeks of treatment, the mean (+/-SE) decrease from baseline in DBP was 9.4+/-0.6 mmHg in the irbesartan group vs. 9.6+/-0.6 mmHg in the amlodipine group (p=0.806). The mean decrease from baseline in seated systolic BP was 12.2+/-1.0 mmHg in the irbesartan group vs. 12.0+/-1.0 mmHg in the amlodipine group (p=0.885). Overall, 62% of subjects in the irbesartan group and 63% in the amlodipine group had a response (p=0.609), and 54% and 56% of patients (p=0.596), respectively, had their DBP normalised (<90 mmHg). Adverse events were reported by 21.3% of patients receiving irbesartan and 20.7% receiving amlodipine. Conclusions. Irbesartan 150 mg demonstrated comparable efficacy to amlodipine 5 mg, thereby confirming its value as an antihypertensive treatment option in non-African American patients with DBP 95-110 mmHg.
本研究的主要目的是比较血管紧张素II受体阻滞剂厄贝沙坦150毫克与钙通道阻滞剂氨氯地平5毫克对坐位舒张压（DBP）为95 - 110毫米汞柱患者的降压疗效。
多中心、随机、双盲、对照性初步研究。
受试者年龄在18 - 65岁之间，DBP为95 - 110毫米汞柱，且非非裔美国人。经过为期三周的单盲安慰剂导入期后，181名受试者按1:1比例随机分组，接受每日一次的厄贝沙坦150毫克（n = 89）或氨氯地平5毫克（n = 92）治疗四周。在标准化、可控条件下，于基线、第2周和第4周测量谷值（给药后24±3小时）血压。反应定义为DBP < 90毫米汞柱或较基线降低10毫米汞柱。
治疗四周后，厄贝沙坦组DBP较基线的平均（±标准误）降幅为9.4±0.6毫米汞柱，氨氯地平组为9.6±0.6毫米汞柱（p = 0.806）。厄贝沙坦组坐位收缩压较基线的平均降幅为12.2±1.0毫米汞柱，氨氯地平组为12.0±1.0毫米汞柱（p = 0.885）。总体而言，厄贝沙坦组62%的受试者和氨氯地平组63%的受试者有反应（p = 0.609），两组分别有54%和56%的患者DBP恢复正常（< 90毫米汞柱）（p = 0.596）。接受厄贝沙坦治疗的患者中有21.3%报告了不良事件，接受氨氯地平治疗的患者中有20.7%报告了不良事件。结论。厄贝沙坦150毫克显示出与氨氯地平5毫克相当的疗效，从而证实了其作为DBP为95 - 110毫米汞柱的非非裔美国患者降压治疗选择的价值。
