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首页> 外文期刊>Cardiovascular therapeutics >Improved Blood Pressure Control with Nifedipine GITS/Valsartan Combination Versus High-Dose Valsartan Monotherapy in Mild-to-Moderate Hypertensive Patients from Asia: Results from the ADVISE Study, a Randomized Trial
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Improved Blood Pressure Control with Nifedipine GITS/Valsartan Combination Versus High-Dose Valsartan Monotherapy in Mild-to-Moderate Hypertensive Patients from Asia: Results from the ADVISE Study, a Randomized Trial

机译：硝苯地平GITS /缬沙坦联合大剂量缬沙坦单药治疗亚洲轻度至中度高血压患者的血压控制得到改善：一项随机试验ADVISE研究的结果

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Aims: ADVISE was a 12-week, multicenter, randomized, prospective, open-label, parallel-group study comparing combination therapy of nifedipine GITS 30 mg plus valsartan 80 mg (N + V) with high-dose valsartan (160 mg) monotherapy (V160) in Asian patients with hypertension. Methods: Patients with hypertension inadequately controlled with valsartan 80 mg for at least 4 weeks were randomized. The coprimary endpoints were the mean changes in clinic systolic and diastolic blood pressures (SBP and DBP, respectively) at Week 12. Other endpoints included blood pressure (BP) control rate, response rate, and adverse events. Results: The full analysis set (FAS) comprised 359 patients. Least squares (LS) mean changes in SBP were -18.3 mmHg (N + V; n = 177) and -16.5 mmHg (V160; n = 182) (difference: -1.9 mmHg; P = 0.0998). DBP LS mean changes were -9.8 mmHg (N + V) and -7.4 mmHg (V160) (difference: -2.4 mmHg; P = 0.0011). BP control rates were significantly higher in the N + V group (Week 4: 51.2% vs. 38.4%, P = 0.0138; Week 8: 68.3% vs. 50.3%, P = 0.0004; and Week 12: 71.2% vs. 55.5%, P = 0.0024). Similar findings were observed when patients were stratified according to smoking status, SBP baseline quartiles, and ESC/ESH guideline-defined added-risk category. The BP response rate was also higher in the N + V group compared with the V160 group. Rates of adverse drug reactions (all mild-to-moderate) were similar: 4.5% (N + V) and 4.4% (V160). Conclusions: Although one of the coprimary endpoints did not reach statistical significance, combination treatment with N + V provided a greater early and more consistent BP-lowering effect than monotherapy with V160, including superior reduction in DBP and BP control rates.
机译：目的：ADVISE是一项为期12周的多中心，随机，前瞻性，开放标签，平行组研究，比较了硝苯地平GITS 30 mg +缬沙坦80 mg（N + V）与大剂量缬沙坦（160 mg）单一疗法的联合治疗（V160）在亚洲高血压患者中。方法：将缬沙坦80 mg控制不足的高血压患者至少4周随机分组。共主要终点是第12周时临床收缩压和舒张压的平均变化（分别为SBP和DBP）。其他终点包括血压（BP）控制率，反应率和不良事件。结果：完整分析集（FAS）包括359名患者。最小二乘（LS）的平均SBP变化为-18.3 mmHg（N + V; n = 177）和-16.5 mmHg（V160; n = 182）（差异：-1.9 mmHg; P = 0.0998）。 DBP LS的平均变化为-9.8 mmHg（N + V）和-7.4 mmHg（V160）（差异：-2.4 mmHg; P = 0.0011）。 N + V组的BP控制率显着更高（第4周：51.2％比38.4％，P = 0.0138;第8周：68.3％比50.3％，P = 0.0004;第12周：71.2％比55.5 ％，P = 0.0024）。根据患者的吸烟状况，SBP基线四分位数和ESC / ESH指南定义的高危类别对患者进行分层时，观察到相似的结果。与V160组相比，N + V组的BP反应率也更高。药物不良反应发生率（全部为轻度至中度）相似：4.5％（N + V）和4.4％（V160）。结论：尽管其中一个主要终点指标未达到统计学显着性，但与V160单药治疗相比，N + V联合治疗提供了更大的早期和更一致的BP降低作用，包括DBP和BP控制率明显降低。

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