复方降压药Tekturna HCT获准作为一线降压药

ST LOUIS (MD Consult) - On July 21, 2009, Novartis announced that the US Food and Drug Administration (FDA) has approved Tekturna HCT as initial treatment for patients with hypertension who are not likely to achieve their blood pressure goals with a single antihypertensive agent. Tekturna HCT is a drug that combines the direct renin inhibitor Tekturna (aliskiren), with the diuretic hydrochlorothiazide (HCTZ), in a single tablet. Tekturna HCT was initially approved in the United States in January 2008 as a second-line treatment for hypertension.

The FDA approval of Tekturna HCT as initial therapy for hypertension was granted on the basis of clinical trial data involving more than 2,700 patients. Study results demonstrated that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone. In clinical trials, the antihypertensive effect of Tekturna HCT was largely manifested within 1 week. The maximum antihypertensive effect was generally attained after about 4 weeks of therapy.

Tekturna HCT is available in 4 strengths (as tablets containing aliskiren and hydrochlorothiazide): 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300 mg/25 mg.

圣路易斯(MD Consult)——2009年7月21日，诺华公司宣布，对于采用单一降压药降压效果不理想者，美国食品药品管理局(FDA)已批准Tekturna HCT作为其初始治疗药。Tekturna HCT是由直接肾素抑制剂Tekturna(阿利吉仑)与利尿剂氢氯噻嗪(HCTZ)配伍制成的复方片剂，最初于2008年1月在美国获准作为高血压的二线治疗药。

FDA批准Tekturna HCT作为高血压初始治疗药是基于逾2,700例患者的临床试验数据。研究结果证实，Tekturna与HCTZ联合治疗获得的血压降幅大于其中任何一种单药治疗。在临床试验中，Tekturna HCT的降压效果大多数在1w内显效，通常在治疗大约4w后，降压效果达峰值。

Tekturna HCT有如下4种配伍规格(含阿利吉仑与氢氯噻嗪的复方片剂)上市：150 mg/12.5 mg，150 mg/25 mg，300 mg/12.5 mg以及 300 mg/25 mg。