Newest FDA Approvals
ST LOUIS (MD Consult) - On September 17, 2009, Novartis announced that the US Food and Drug Administration (FDA) has approved Valturna for the treatment of certain patients with hypertension. Valturna is a single-pill combination of valsartan, an angiotensin-receptor blocker, with aliskiren, a direct renin inhibitor. Patients for whom Valturna is indicated are those whose blood pressure has not been adequately controlled on aliskiren or angiotensin-receptor blocker (ARB) monotherapy. The drug is also indicated for use in patients who are likely to need multiple drugs to achieve their blood pressure goals.
This FDA approval was granted primarily on the basis of data from a pivotal 8-week randomized, double-blind, placebo-controlled clinical trial involving approximately 1,800 patients. Investigators studied aliskiren at doses of 150 mg and 300 mg and valsartan at doses of 160 mg and 320 mg, alone and in combination. The initial doses of aliskiren and valsartan were 150 mg and 160 mg, respectively, and were increased at 4 weeks to 300 mg and 320 mg, respectively. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the 8-week primary end point. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mm Hg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mm Hg for valsartan 320 mg, 13.0/9.0 mm Hg for aliskiren 300 mg, and 4.6/4.1 mm Hg for placebo (P < .05 for aliskiren/valsartan vs monotherapies or placebo).
Valturna is available in 2 strengths as tablets containing aliskiren and valsartan: 150 mg/160 mg and 300 mg/320 mg.
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FDA最新批准
圣路易斯（MD Consult）——2009年9月17日，诺华公司宣称其产品Valturna已获美国食品药品管理局(FDA)批准用于某些高血压病患者的治疗。Valturna是包括一种血管紧张素受体阻断剂(ARB)缬沙坦和一种直接肾素抑制剂阿利吉仑的复方制剂。Valturna的适应证为单纯阿利吉仑或单纯血管紧张素受体阻断剂治疗未能充分控制的高血压病患者，同时也适用于可能需要多种药物联合应用方可达到血压控制目标的高血压病患者。
FDA批准Valturna应用的基础为一项纳入约1,800例患者的为期8周的随机、双盲、安慰剂对照的临床研究数据。研究者对阿利吉仑150 mg和300 mg以及缬沙坦160 mg和320 mg剂量单药和联合应用的疗效进行了分析。阿利吉仑和缬沙坦的初始剂量分别为150 mg 和160 mg，4周后分别增加到300 mg和320 mg。阿利吉仑/缬沙坦联合治疗组研究主要终点——8周时血压降低幅度显著大于单药治疗或安慰剂组。阿利吉仑300 mg /缬沙坦320 mg组平均收缩压和舒张压较基线的降低为17.2 mm Hg/12.2 mm Hg，而缬沙坦320 mg、阿利吉仑300 mg和安慰剂组相应数值分别为12.8 mm Hg/9.7 mm Hg、13.0 mm Hg/9.0 mm Hg和4.6 mm Hg/4.1 mm Hg（阿利吉仑/缬沙坦组与单药治疗或安慰剂组比较，P <0.05）。
现有Valturna为2种规格的片剂，分别包含阿利吉仑150 mg /缬沙坦160 mg和阿利吉仑300 mg /缬沙坦320 mg。
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