Objective: To evaluate the current role of aliskiren, a direct renin inhibitor, in the pharmacologic treatment of essential hypertension. Data Sources: A literature search of OVID MEDLINE and PubMed (both from 1950 through November 1, 2011) using the terms aliskiren and efficacy was conducted. In addition, reference citations from publications identified were reviewed. Study Selection and Data Extraction: All articles in English comparing aliskiren or an aliskiren-based regimen with another antihypertensive pharmacotherapy regimen in humans were identified. Articles were selected if they were on randomized controlled trials with blood pressure reduction as their primary objective. Trials included over 100 patients with mild-to-moderate essential hypertension. Data Synthesis: Aliskiren has been studied against or in combination with hydrochlorothiazide, amlodipine, ramipril, losartan, irbesartan, valsartan, and atenolol. It is statistically superior to hydrochlorothiazide and ramipril at lowering blood pressure, and equally as effective as losartan, irbesartan, and atenolol, with a similar safety profile. Aliskiren is an effective add-on agent to valsartan, amlodipine, and atenolol therapy. Although aliskiren is beneficial, alternative agents exist that can be used with similar efficacy for lower cost. Conclusions: Aliskiren is an effective antihypertensive agent, used either as monotherapy or in combination with other antihypertensive medications. The lack of evidence for long-term morbidity and mortality benefits makes it difficult to consider aliskiren a primary agent for the treatment of hypertension. The completion of the ASPIRE HIGHER program, a collection of trials whose aim is to demonstrate short- and long-term benefits of aliskiren on end-organ damage, is needed to justify the use of aliskiren other than as a last-line antihypertensive agent.
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