FDA批准治疗高血压的复方制剂Exforge HCT

ST LOUIS (MD Consult) - On April 30, 2009, Novartis announced that the US Food and Drug Administration (FDA) has approved Exforge HCT for the treatment of hypertension. Exforge HCT is a combination of 3 antihypertensive medications in one pill: the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide. The manufacturer expects Exforge HCT to be an important new option for patients whose conditions have been unsuccessfully managed on a regimen of dual combinations of these classes of antihypertensives.

Exforge HCT has been shown to effectively manage blood pressure in patients with moderate to severe hypertension (ie, systolic blood pressure readings ranging from 145 mm Hg to <200 mm Hg and diastolic blood pressure readings ranging from 100 mm Hg to <120 mm Hg). In a clinical trial, patients receiving the maximum dose of Exforge HCT (amlodipine/valsartan/ hydrochlorothiazide 10 mg/320 mg/25 mg) demonstrated additional reductions of 18% to 29% in systolic blood pressure and 19% to 32% in diastolic blood pressure when compared with patients receiving all dual combinations of its components at the same doses. The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mm Hg greater than with valsartan/hydrochlorothiazide 320 mg/25 mg; 6.2/3.3 mm Hg greater than with amlodipine/valsartan 10mg/320 mg; and 8.2/5.3 mm Hg greater than with amlodipine/hydrochlorothiazide 10 mg/25 mg. These results also include a placebo effect of unknown size. Ambulatory blood pressure monitoring showed that the blood pressure lowering effect of Exforge HCT was maintained throughout a 24-hour period.

Treatment with single-pill combination Exforge HCT may be considered for patients whose blood pressure is not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. In studies, the full blood pressure lowering effect was achieved 2 weeks after maintenance on the maximal dose of Exforge HCT.

According to Novartis, Exforge and Exforge HCT will be offered at the same price in the United States on a dose-equivalent basis. Because Exforge HCT contains 3 medications in a single pill, patients who are prescribed this medication may benefit from reduced insurance copayments.
 

圣路易斯 (MD Consult) – 2009年4月30日，诺华公司宣布美国食品药品管理局(US Food and Drug Administration, FDA)已经批准Exforge HCT用于治疗高血压。该药是同时含有三种抗高血压处方药物成分的复合制剂，这三种成分分别为钙通道拮抗剂/氨氯地平，血管紧张素受体拮抗剂/缬沙坦，和利尿剂/双氢克尿塞。制造商希望Exforge HCT成为那些应用两种类型抗高血压药物联合治疗后效果不佳患者一种重要的新选择。

Exforge HCT可有效治疗中重度高血压患者(例如，收缩压范围:145 mm Hg～200 mm Hg，舒张压范围:100 mm Hg～120 mm Hg)。一项临床试验显示，患者接受最高剂量的Exforge HCT(氨氯地平/缬沙坦/双氢克尿塞: 10mg/320mg/25mg)与采用相同剂量的所有上述两种药物联合治疗相比，收缩压可多下降18%~29%，舒张压可多下降19%~32%。Exforge HCT较缬沙坦/双氢克尿塞320mg/25mg使收缩压/舒张压分别多下降7.6/5.0 mmHg；较氨氯地平/缬沙坦10mg/320mg使收缩压/舒张压多下降6.2/3.3 mmHg；较氨氯地平/双氢克尿塞10mg/25mg使血压多下降8.2/5.3 mmHg。这些结果也包括一项未知样本大小的安慰剂效应。动态血压监测显示Exforge HCT的降压效果可持续24小时。

采用任何2种下列药物治疗后效果不理想的患者可改用单一复方制剂Exforge HCT，这些抗压药包括：钙通道阻滞剂、血管紧张素受体阻滞剂和利尿剂。实验表明，患者使用最高剂量的Exforge HCT治疗2周之后，降压效果非常理想。

根据诺华的消息，同等剂量的Exforge和Exforge HCT在美国售价相同。因为Exforge HCT含有3种药物成份，使用这种处方药的患者与保险公司共同承担的医药费会有所下降。

爱思唯尔  版权所有