Meta-Analysis of 12 Trials with n = 12,188 Patients (2010) [MEDLINE]: incidence of angioedema was 0,4% (same as that for ACE inhibitors)
Retrospective Study with n = 4,687 Patients (2012): incidence of angioedema was comparable for ACE inhibitors and aliskiren
Meta-Analysis with n= 5,141 Patients (2012) [MEDLINE]: incidence of angioedema was 0.13%
Physiology: aliskiren is not believed to affect bradykinin pathways -> mechanism is unclear
Clinical Use: caution should be exercised in using aliskiren (and other renin inhibitors) in patients who have had a history of angioedema associated with ACE inhibitor treatment (see Angiotensin Converting Enzyme Inhibitors, [[Angiotensin Converting Enzyme Inhibitors]])
Mechanism: due to drug-induced hypoaldosteronism (see above)
Other Adverse Effects
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References
Safety and tolerability of the direct renin inhibitor aliskiren: a pooled analysis of clinical experience in more than 12,000 patients with hypertension. J Clin Hypertens (Greenwich). 2010 Oct;12(10):765-75. doi: 10.1111/j.1751-7176.2010.00352.x [MEDLINE]
Meta-analysis of randomized trials of angioedema as an adverse event of renin-angiotensin system inhibitors. Am J Cardiol. 2012 Aug 1;110(3):383-91. doi: 10.1016/j.amjcard.2012.03.034. Epub 2012 Apr 20 [MEDLINE]
Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system. Arch Intern Med. 2012 Nov 12;172(20):1582-9. doi: 10.1001/2013.jamainternmed.34 [MEDLINE]