What does this research mean for the field?

Compared to beta-blockers, ACE inhibitors and aliskiren are associated with an approximately 3-fold higher risk for angioedema, whereas angiotensin receptor blockers (ARBs) carry a significantly lower risk. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the absolute and comparative risk for angioedema associated with the initiation of ACE inhibitors, ARBs, and the direct renin inhibitor aliskiren compared with beta-blockers.

November 12, 2012Archives of Internal Medicine

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

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Why the study?

Does the use of ACEIs, ARBs, or aliskiren increase the risk of angioedema compared to beta-blockers in adult patients?

Population

3,909,596 patients 18 years or older from 17 health plans participating in the Mini-Sentinel program who…

Comparison

Angiotensin converting enzyme inhibitors… vs β-blockers.

Design

Cohort

Follow-up

maximal 365 days

Authors

STSengwee TohHarvard University MRMarsha E. ReichmanCross-Cutting Cardiology MHMonika HoustounUnited States Food and Drug Administration

Discussion

Member takes

Implication

Angioedema risk with ACEIs and aliskiren merits clinical attention; hypothesis-generating for ARB comparisons and requires randomized confirmation.

Key Points

To assess the absolute and comparative risk for angioedema associated with the initiation of ACE inhibitors, ARBs, and the direct renin inhibitor aliskiren compared with beta-blockers.
Retrospective observational inception cohort study using data from 17 health plans in the Mini-Sentinel program between January 1, 2001, and December 31, 2010.
Included adults aged 18 years or older initiating ACEIs (n = 1,845,138), ARBs (n = 467,313), aliskiren (n = 4,867), or beta-blockers (n = 1,592,278) with up to 365 days of follow-up.
Calculated cumulative incidence and incidence rates per 1,000 person-years, and estimated adjusted hazard ratios using propensity score methods with beta-blockers as the reference.
A total of 4,511 angioedema events occurred; incidence rates per 1,000 person-years were 4.38 (95% CI, 4.24-4.54) for ACEIs, 1.66 (95% CI, 1.47-1.86) for ARBs, 4.67 (95% CI, 1.88-9.63) for aliskiren, and 1.67 (95% CI, 1.56-1.78) for beta-blockers.
Compared with beta-blockers, adjusted hazard ratios for angioedema were 3.04 (95% CI, 2.81-3.27) for ACEIs, 2.85 (95% CI, 1.34-6.04) for aliskiren, and 1.16 (95% CI, 1.00-1.34) for ARBs.

Structured PICO

Does the use of ACEIs, ARBs, or aliskiren increase the risk of angioedema compared to beta-blockers in adult patients?

Population

3,909,596 patients 18 years or older from 17 health plans participating in the Mini-Sentinel program who initiated the use of an ACEI (n = 1,845,138), an ARB (n = 467,313), aliskiren (n = 4,867), or a β-blocker (n = 1,592,278) between January 1, 2001, and December 31, 2010.

Intervention

Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or the direct renin inhibitor aliskiren.

Comparator

β-blockers (used as a reference group for propensity score adjusted comparison).

Outcome

Cumulative incidence and incidence rate of angioedema during a maximal 365-day follow-up period.safety

ACE inhibitors and aliskiren are associated with an approximately 3-fold higher risk of angioedema compared to beta-blockers, whereas ARBs carry a significantly lower risk.

Limitations

Small number of exposed events for aliskiren

Cite This Study

Toh et al. (2012) studied this question.

synapsesocial.com/papers/6a1bef67d54006be995f4192 https://doi.org/10.1001/2013.jamainternmed.34

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Implication

Angioedema risk with ACEIs and aliskiren merits clinical attention; hypothesis-generating for ARB comparisons and requires randomized confirmation.

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider