Neutel J M, Kolloch R E, Plouin P F, Meinicke T W, Schumacher H
Orange County Heart Institute & Research Center, Orange, CA 92868, USA.
J Hum Hypertens. 2003 Aug;17(8):569-75. doi: 10.1038/sj.jhh.1001592.
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 < or =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.
这项前瞻性、随机、开放标签、终点设盲的平行组多中心研究的目的是证明，对于轻至中度高血压患者，80毫克替米沙坦在降低24小时平均动态舒张压（DBP）方面不劣于50毫克氯沙坦/12.5毫克氢氯噻嗪（HCTZ）的固定剂量组合。非劣效性标准是从4周安慰剂洗脱期结束到6周积极治疗期结束时，24小时平均动态舒张压降低的治疗差异≤3.0毫米汞柱。在意向性分析中，替米沙坦治疗组（n = 332）患者24小时DBP的平均降低值为8.3±6.7毫米汞柱，氯沙坦/HCTZ治疗组（n = 350）患者为10.3±6.3毫米汞柱。两个治疗组之间24小时DBP的平均校正差异为1.9毫米汞柱，从而可以拒绝治疗差异>3毫米汞柱的先验无效假设。替米沙坦治疗时24小时平均收缩压降低13.2±10.2毫米汞柱，氯沙坦/HCTZ治疗时为17.1±10.3毫米汞柱。两种药物在24小时给药间隔内均能有效控制血压。对早晨（06:00 - 11:59）动态血压监测DBP均值和谷值袖带DBP的分析证实了80毫克替米沙坦对比50毫克氯沙坦/12.5毫克HCTZ方案的非劣效性假设。替米沙坦治疗患者在谷值时测量的诊室血压降低值为-16.3 / -9.6毫米汞柱，氯沙坦/HCTZ治疗患者为-18.5 / -11.1毫米汞柱（差异为-2.4 / -1.2毫米汞柱）。两种治疗的副作用谱无差异。
