Telmisartan vs losartan plus hydrochlorothiazide in the treatment of mild-to-moderate essential hypertension—a randomised ABPM study
Telmisartan vs losartan plus hydrochlorothiazide in the treatment of mild-to-moderate essential hypertension—a randomised ABPM study
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替米沙坦与氯沙坦联合氢氯噻嗪治疗轻中度原发性高血压——一项随机 ABPM 研究
DOI：
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发表时间：
2003
影响因子：
2.7
通讯作者：
H. Schumacher
中科院分区：
文献类型：
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作者：
J. Neutel;R. Kolloch;P. Plouin;T. Meinicke;H. Schumacher
这项前瞻性、随机化、开放标签、设盲终点、平行组、多中心研究的目的是证明在轻中度高血压患者中，替米沙坦80 mg不劣于氯沙坦50 mg/氢氯噻嗪（HCTZ）12.5 mg固定剂量复方制剂。非劣效性标准为从4周安慰剂洗脱期结束至6周活性治疗期结束，24小时平均动态舒张压（DBP）降低的治疗差异≥ 3.0 mmHg。在意向治疗分析中，替米沙坦治疗患者（n=332）和氯沙坦/HCTZ治疗患者（n=350）的24小时DBP平均降低值分别为8.3±6.7 mmHg和10.3±6.3 mmHg。两个治疗组之间24小时DBP的平均校正差异为1.9 mmHg，允许拒绝治疗差异>3 mmHg的先验零假设。替米沙坦组平均24小时收缩压降低13.2±10.2 mmHg，氯沙坦/HCTZ组平均24小时收缩压降低17.1±10.3 mmHg。两种药物在24小时给药间隔内均提供了有效控制。清晨（0600-1159）动态血压监测DBP平均值和袖带DBP谷值的分析证实了方案中替米沙坦80 mg与氯沙坦50 mg/HCTZ 12.5 mg相比的非劣效性假设。在接受替米沙坦治疗的患者中，在谷值时测量的诊室血压降低值为−16.3/−9.6 mmHg，在接受氯沙坦/HCTZ治疗的患者中为−18.5/−11.1 mmHg（差异为−2.4/−1.2 mmHg）。两种治疗的副作用特征之间没有差异。
The objective of this prospective, randomised, open-label, blinded-end point parallel-group, multicentre study was to show that telmisartan 80 mg is not inferior to a fixed-dose combination of losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg in patients with mild-to-moderate hypertension. The criterion for noninferiority was a treatment difference of ⩽3.0 mmHg in the reduction of 24-h mean ambulatory diastolic blood pressure (DBP) from the end of the 4-week placebo washout period to the end of the 6-week active treatment period. In the intent-to-treat analysis, the mean reduction in 24-h DBP was 8.3±6.7 mmHg among telmisartan-treated patients (n=332) and 10.3±6.3 mmHg among losartan/HCTZ-treated patients (n=350). The mean adjusted difference in 24-h DBP between the two treatment groups was 1.9 mmHg, allowing rejection of the a priori null hypothesis of a treatment difference of >3 mmHg. The reduction in mean 24-h systolic blood pressure was 13.2±10.2 mmHg with telmisartan and 17.1±10.3 mmHg with losartan/HCTZ. Both drugs provided effective control over the 24-h dosing interval. Analyses of morning (0600–1159) ambulatory blood pressure monitoring DBP means and trough cuff DBP confirmed the noninferiority hypothesis of the protocol for telmisartan 80 mg vs losartan 50 mg/HCTZ 12.5 mg. The reductions in office blood pressures measured at trough in patients treated with telmisartan were −16.3/−9.6 and −18.5/−11.1 mmHg in the patients treated with losartan/HCTZ (difference −2.4/−1.2 mmHg). There were no differences between the side-effect profiles of the two treatments.
影响因子：
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作者：
Psaty, BM;Furberg, CD;Lumley, T
通讯作者：
Lumley, T