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, Robert Bresalier, Allen P. Kaplan, Biff F. Palmer, Robert H. Riddell, Anastasia Lesogor, William Chang, Deborah L. Keefe

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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.

Original languageEnglish (US)
Pages (from-to)506-516
Number of pages11
JournalJournal of clinical hypertension
Volume13
Issue number7
DOIs
StatePublished - Jul 2011

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Sodium Chloride Symporter Inhibitors
Angiotensin Receptor Antagonists
Renin
Safety
Diuretics
Valsartan
Losartan
aliskiren
Hypertension
Therapeutics
Angioedema
Hyperkalemia
Randomized Controlled Trials
Databases

ASJC Scopus subject areas

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

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

In: Journal of clinical hypertension, Vol. 13, No. 7, 07.2011, p. 506-516.

Research output: Contribution to journalArticle

White, William B. ; Bresalier, Robert ; Kaplan, Allen P. ; Palmer, Biff F. ; Riddell, Robert H. ; Lesogor, Anastasia ; Chang, William ; Keefe, Deborah L. / 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. In: Journal of clinical hypertension. 2011 ; Vol. 13, No. 7. pp. 506-516.
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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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