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. 2011 Jul;13(7):506-16.
doi: 10.1111/j.1751-7176.2011.00438.x. Epub 2011 Mar 18.

Safety and tolerability of the direct renin inhibitor aliskiren in combination with angiotensin receptor blockers and thiazide diuretics: a pooled analysis of clinical experience of 12,942 patients

William B White  1 , Robert Bresalier, Allen P Kaplan, Biff F Palmer, Robert H Riddell, Anastasia Lesogor, William Chang, Deborah L Keefe
Affiliations

Safety and tolerability of the direct renin inhibitor aliskiren in combination with angiotensin receptor blockers and thiazide diuretics: a pooled analysis of clinical experience of 12,942 patients

William B White et al. J Clin Hypertens (Greenwich). 2011 Jul.

Abstract

Combinations of the direct renin inhibitor aliskiren with angiotensin receptor blockers (ARBs) or diuretics are effective therapeutic regimens for the treatment of hypertension. A large database of safety information has become available during the past several years with aliskiren in combination trials. Data were pooled from 9 short-term (8-week) and 4 longer-term (26- to 52-week) randomized controlled trials of aliskiren in patients with hypertension. Adverse event (AE) rates were assessed for aliskiren combination therapy compared with component monotherapies. In short-term studies, overall AE rates were similar for patients receiving aliskiren/valsartan or aliskiren/diuretic combinations (32.2%-39.8%) and those receiving the component monotherapies (30.0%-39.6%). In longer-term studies, AE rates with aliskiren/losartan (55.5%) and aliskiren/diuretic (45.0%) combination therapy were similar to those with losartan (53.9%) and diuretic (48.9%) alone. Angioedema and hyperkalemia occurred in similar proportions of patients taking combination therapies vs monotherapy. The safety and tolerability profile of aliskiren in combination with the ARBs valsartan or losartan, or diuretic, is similar to aliskiren, ARBs, or diuretics alone.

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Figures

Figure FIGURE
Figure FIGURE
Relative risks (RRs) of adverse events of special interest with aliskiren/angiotensin receptor blocker (ARB) combination compared with ARB and aliskiren monotherapy in the short‐term studies. CI indicates confidence interval; ND, not determined.
See this image and copyright information in PMC

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