Document Detail


Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system.
MedLine Citation:
PMID:  23147456     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Although certain drugs that target the renin- angiotensin-aldosterone system are linked to an increased risk for angioedema, data on their absolute and comparative risks are limited. We assessed the risk for angioedema associated with the use of angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and the direct renin inhibitor aliskiren.
METHODS: We conducted a retrospective, observational, inception cohort study of patients 18 years or older from 17 health plans participating in the Mini-Sentinel program who had initiated the use of an ACEI (n = 1 845 138), an ARB (n = 467 313), aliskiren (n = 4867), or a β-blocker (n = 1 592 278) between January 1, 2001, and December 31, 2010. We calculated the cumulative incidence and incidence rate of angioedema during a maximal 365-day follow-up period. Using β-blockers as a reference and a propensity score approach, we estimated the hazard ratios of angioedema separately for ACEIs, ARBs, and aliskiren, adjusting for age, sex, history of allergic reactions, diabetes mellitus, heart failure, or ischemic heart disease, and the use of prescription nonsteroidal anti-inflammatory drugs.
RESULTS: A total of 4511 angioedema events (3301 for ACEIs, 288 for ARBs, 7 for aliskiren, and 915 for β-blockers) were observed during the follow-up period. The cumulative incidences per 1000 persons were 1.79 (95% CI, 1.73-1.85) cases for ACEIs, 0.62 (95% CI, 0.55-0.69) cases for ARBs, 1.44 (95% CI, 0.58-2.96) cases for aliskiren, and 0.58 (95% CI, 0.54-0.61) cases for β-blockers. The incidence rates per 1000 person-years were 4.38 (95% CI, 4.24-4.54) cases for ACEIs, 1.66 (95% CI, 1.47-1.86) cases for ARBs, 4.67 (95% CI, 1.88-9.63) cases for aliskiren, and 1.67 (95% CI, 1.56-1.78) cases for β-blockers. Compared with the use of β-blockers, the adjusted hazard ratios were 3.04 (95% CI, 2.81-3.27) for ACEIs, 1.16 (95% CI, 1.00-1.34) for ARBs, and 2.85 (95% CI, 1.34-6.04) for aliskiren.
CONCLUSIONS: Compared with β-blockers, ACEIs or aliskiren was associated with an approximately 3-fold higher risk for angioedema, although the number of exposed events for aliskiren was small. The risk for angioedema was lower with ARBs than with ACEIs or aliskiren.
Authors:
Sengwee Toh; Marsha E Reichman; Monika Houstoun; Mary Ross Southworth; Xiao Ding; Adrian F Hernandez; Mark Levenson; Lingling Li; Carolyn McCloskey; Azadeh Shoaibi; Eileen Wu; Gwen Zornberg; Sean Hennessy
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Archives of internal medicine     Volume:  172     ISSN:  1538-3679     ISO Abbreviation:  Arch. Intern. Med.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-13     Completed Date:  2013-03-12     Revised Date:  2014-01-06    
Medline Journal Info:
Nlm Unique ID:  0372440     Medline TA:  Arch Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1582-9     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Angioedema / chemically induced*,  epidemiology*
Angiotensin Receptor Antagonists / adverse effects*
Angiotensin-Converting Enzyme Inhibitors / adverse effects*
Female
Follow-Up Studies
Humans
Incidence
Male
Middle Aged
Renin-Angiotensin System / drug effects*
Retrospective Studies
Risk Factors
Time Factors
United States / epidemiology
Young Adult
Grant Support
ID/Acronym/Agency:
HHSF223200910006I//PHS HHS
Chemical
Reg. No./Substance:
0/Angiotensin Receptor Antagonists; 0/Angiotensin-Converting Enzyme Inhibitors
Comments/Corrections
Comment In:
Evid Based Med. 2013 Dec;18(6):e52   [PMID:  23635842 ]
Dtsch Med Wochenschr. 2013 Feb;138(7):302   [PMID:  23392998 ]
Arch Intern Med. 2012 Nov 12;172(20):1590   [PMID:  23070135 ]
Erratum In:
Arch Intern Med. 2013 Jan 14;173(1):14

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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