Peter Doris
Core Medical Publishing, New York, USA.
Core Evid. 2005;1(1):13-22. Epub 2005 Mar 31.
Aliskiren is the first in a new class of antihypertensive drugs that inhibits the conversion of angiotensinogen to angiotensin I by renin, thereby inhibiting production of angiotensin II, the key mediator in the regulation of body fluid volume and blood pressure. Aliskiren is currently in phase III trials as monotherapy and phase II as combination therapy in patients with mild-to-moderate hypertension, and in phase II trials in patients with diabetic nephropathy.
The aim of this review is to evaluate the emerging evidence for use of aliskiren in patients with hypertension and to predict its preliminary place in therapy in clinical outcome terms. All randomized, controlled clinical trials of aliskiren (evidence level 2) were included for analysis of efficacy with the selected outcomes of blood pressure lowering, tolerability, and adherence; all other publications were excluded.
The available level 2 evidence, although limited to phase II trials, suggests that aliskiren is effective at lowering blood pressure, an accepted surrogate outcome of morbidity and mortality, in patients with mild-to-moderate uncomplicated essential hypertension. Preliminary evidence suggests aliskiren is as effective as the angiotensin receptor blocker irbesartan, but more studies are needed. The available evidence also suggests that aliskiren is well tolerated and that patients exhibit good adherence to therapy. Aliskiren's effect on outcomes such as all-cause mortality, reduction in cardiovascular mortality, and reduction in cardiovascular events in patients with mild-to-moderate essential hypertension as well as in special patient populations, remains to be determined.
The evidence available regarding aliskiren's effect on outcomes, including blood pressure, tolerability, and adherence, supports its use in patients with mild-to-moderate hypertension. Although there is some preliminary evidence from small pilot trials, the use of aliskiren in combination with other antihypertensives, and the use of aliskiren in other patient populations, cannot be recommended without further evidence.
阿利吉仑是一类新型抗高血压药物中的首个药物，它通过肾素抑制血管紧张素原转化为血管紧张素I，从而抑制血管紧张素II的生成，血管紧张素II是调节体液容量和血压的关键介质。阿利吉仑目前在轻度至中度高血压患者中作为单一疗法处于III期试验阶段，作为联合疗法处于II期试验阶段，在糖尿病肾病患者中处于II期试验阶段。
本综述的目的是评估阿利吉仑在高血压患者中应用的新证据，并从临床结局角度预测其在治疗中的初步地位。纳入所有阿利吉仑的随机对照临床试验（证据水平2），以分析其降低血压、耐受性和依从性等选定结局的疗效；排除所有其他出版物。
现有的证据水平2的证据，虽然仅限于II期试验，但表明阿利吉仑在轻度至中度无并发症的原发性高血压患者中能有效降低血压，血压降低是发病率和死亡率的一个公认替代结局。初步证据表明阿利吉仑与血管紧张素受体阻滞剂厄贝沙坦一样有效，但还需要更多研究。现有证据还表明阿利吉仑耐受性良好，患者对治疗的依从性也较好。阿利吉仑对轻度至中度原发性高血压患者以及特殊患者群体的全因死亡率、心血管死亡率降低和心血管事件减少等结局的影响仍有待确定。
关于阿利吉仑对包括血压、耐受性和依从性等结局影响的现有证据支持其在轻度至中度高血压患者中的应用。虽然从小型试点试验中有一些初步证据，但在没有进一步证据的情况下，不建议将阿利吉仑与其他抗高血压药物联合使用，也不建议在其他患者群体中使用阿利吉仑。
