Safety and tolerability of the direct renin inhibitor aliskiren: A Pooled analysis of clinical experience in more than 12,000 patients with hypertension

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

Research output: Contribution to journalArticle

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Abstract

While the safety of renin-angiotensin system (RAS)-blocking drugs such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers is well known, less is known about the new direct renin inhibitor aliskiren. The authors pooled data from 12 randomized controlled trials of aliskiren in patients with hypertension and analyzed the incidence and types of adverse events (AEs) and laboratory abnormalities. Studies were characterized as short-term (≤2 months) placebo-controlled or long-term (>2 months) active-controlled. Relative risks for AEs of particular interest for RAS blockers were calculated. In short-term studies, AEs occurred in similar proportions of aliskiren 150 mg and 300 mg (33.6% and 31.6%, respectively) and placebo treatment groups (36.8%). In long-term studies, a lower proportion of patients treated with aliskiren 150 mg and 300 mg had AEs (33.7% and 43.2%, respectively) than those treated with ACE inhibitors (60.1%), angiotensin receptor blockers (53.9%), and thiazide diuretics (48.9%). Events of special interest, including angioedema, hyperkalemia, and diarrhea occurred in similar proportions of patients taking aliskiren, placebo, and comparator agents. In studies of up to 36 weeks, patients treated with aliskiren were significantly less likely to develop cough than those treated with ACE inhibitors. At the registered doses of 150 mg and 300 mg daily, aliskiren has safety and tolerability profiles similar to placebo, other RAS blockers, and diuretics. Cough rates are lower with aliskiren compared with ACE inhibitors.

Original languageEnglish (US)
Pages (from-to)765-775
Number of pages11
JournalJournal of clinical hypertension
Volume12
Issue number10
DOIs
StatePublished - Oct 2010

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Renin
Hypertension
Safety
Angiotensin-Converting Enzyme Inhibitors
Renin-Angiotensin System
Placebos
Angiotensin Receptor Antagonists
Cough
Sodium Chloride Symporter Inhibitors
Angioedema
Hyperkalemia
aliskiren
Anniversaries and Special Events
Diuretics
Diarrhea
Randomized Controlled Trials
Incidence
Pharmaceutical Preparations

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 : A Pooled analysis of clinical experience in more than 12,000 patients with hypertension. / 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. 12, No. 10, 10.2010, p. 765-775.

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 : A Pooled analysis of clinical experience in more than 12,000 patients with hypertension. In: Journal of clinical hypertension. 2010 ; Vol. 12, No. 10. pp. 765-775.
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