What is the evidence behind the safety of trying an ARB in a patient with a history of angioedema on lisinopril?

Comment by InpharmD Researcher

Limited data have assessed trialing ARBs in patients with history of angioedema on lisinopril; due to scant evidence assessing safety, conclusions cannot be properly drawn for this clinical scenario. In general, the incidence of recurrent angioedema in ARB recipients who have sensitivity to an ACE inhibitor appears to be low. A meta-analysis estimates the incidence of recurrence to be approximately 9.4% for possible cases and 3.5% for confirmed cases. There is limited guidance regarding challenging an ARB in a patient that experienced a severe angioedema reaction to an ACE inhibitor. While use of an ARB is not contraindicated in patients who experienced ACE inhibitor-related angioedema, both ACE inhibitors and ARBs should be avoided in cases of severe or life-threatening angioedema. For patients with less severe reactions to ACE inhibitors, it is suggested that ARBs may be used with close monitoring if benefits outweigh the risks.

Background

A review of expert opinions by international experts in angioedema and emergency medicine notes that both angiotensin-converting enzyme inhibitors (ACEis) and angiotensin II receptor blockers (ARBs) should be avoided in case of a life-threatening attack of angioedema. For patients with less severe reactions to ACEi, ARBs may be used with close monitoring if benefits outweigh the risks, such as in chronic heart failure. [1]

Per the 2015 British Society for Allergy and Clinical Immunology (BSACI) guideline, given the occasional reports of ARB-associated angioedema, use of ARBs in individuals with ACEi-related angioedema has been questioned but is not contraindicated. The guideline makes no further recommendations on stepwise challenging algorithms in this scenario. [2]

A meta-analysis of randomized controlled trials (RCTs) evaluating the use of ARBs in 8,320 patients with intolerance to ACEis found angioedema/anaphylaxis to be rare, with placebo-like tolerability with incidences of 0.12% for ARBs and 0.07% for placebo. The risk of angioedema was nonsignificant compared to placebo (1.62; 95% confidence interval [CI] 0.17 to 15.79). The authors found that ARBs are well tolerated in patients with ACEi intolerance. [3]

Another meta-analysis examined an RCT and two retrospective cohorts which included a population of patients who were given an ARB after previously experiencing angioedema after taking an ACEi and who were followed up for at least one month for the development of angioedema. It was found that the risk of developing subsequent angioedema while taking an ARB was 9.4% (95% CI 1.6% to 17%), and the risk of developing confirmed angioedema was 3.5% (95% CI 0.0% to 9.2%). The authors concluded that the data, though limited, suggests that an ARB can be used in patients with prior ACEi intolerance, provided that they are suitably advised on the risk of recurrent angioedema. [4]

According to a review article of two randomized controlled studies and one meta-analysis, ARBs may be an alternative option for patients with angioedema induced by an ACEi when there is a high therapeutic need for angiotensin inhibition. As noted above, the data estimates persistent angioedema to be 9.4% (95% CI 1.6% to 17%) for possible cases and 3.5% (95% CI 0.0% to 9.2%) for confirmed cases. Angioedema related to ARBs is considered to be less severe and occurs earlier compared to angioedema induced by ACEi therapy. It is suggested that ARB treatment should be initiated with observation, education on the signs of angioedema, and proper emergency management. [5]

Additionally, a meta-analysis of RCTs in patients on ACEis (26 RCTs; n= 74,857), ARBs (19 RCTs; n= 35,479), or direct renin inhibitor (DRI; 2 trials; n= 5,141) aimed to determine the risk of angioedema associated with each therapeutic class. In head-to-head comparisons from seven trials, the risk of angioedema with ACE inhibitors was 2.2 times higher than with ARBs (95% CI 1.5 to 3.3). On the other hand, in seven trials comparing ARBs to placebo, there was no significant difference in risk of angioedema (95% CI 0.39 to 3.61, p= 0.77). Incidence of angioedema was higher in heart failure trials compared to hypertension or coronary artery disease trials for both ACEi and ARBs. Subgroup analysis did not observe a higher incidence of angioedema in patients with ACEi intolerance (0.11%) compared to those without ACE inhibitor intolerance (0.11%, p= 0.84). The authors concluded that the incidence of angioedema with ARBs was less than half that with ACE inhibitors and not significantly different from placebo. As many trials only reported adverse effects occurring in greater than 1% of patients, there’s a possibility of underestimating the overall incidence of angioedema. [6]

Lastly, a 2015 review discusses the risk of recurrence of angioedema after switching from ACEis to ARBs and explains that the lack of effect on bradykinin metabolism may lead to a lower incidence of angioedema, as reported in the meta-analysis above. It should be noted that most reported recurrent angioedema upon initiation of ARBs occurred shortly after substitution, suggesting residual effects from previous ACEi regimens. With combined data, switching ACEis to ARBs in patients with previous ACEi-induced angioedema is considered safe. However, close monitoring of these patients is still mandatory. Again, medications from both therapeutic classes should be avoided in patients with a previous severe, life-threatening ACEi angioedema. [7]

References:

[1] Bernstein JA, Cremonesi P, Hoffmann TK, Hollingsworth J. Angioedema in the emergency department: a practical guide to differential diagnosis and management. Int J Emerg Med. 2017;10(1):15. doi:10.1186/s12245-017-0141-z
[2] Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy. 2015;45(3):547-565. doi:10.1111/cea.12494\
[3] Caldeira D, David C, Sampaio C. Tolerability of angiotensin-receptor blockers in patients with intolerance to angiotensin-converting enzyme inhibitors: a systematic review and meta-analysis. Am J Cardiovasc Drugs. 2012;12(4):263-277. doi:10.1007/BF03261835
[4] Haymore BR, Yoon J, Mikita CP, Klote MM, DeZee KJ. Risk of angioedema with angiotensin receptor blockers in patients with prior angioedema associated with angiotensin-converting enzyme inhibitors: a meta-analysis. Ann Allergy Asthma Immunol. 2008;101(5):495-499. doi:10.1016/S1081-1206(10)60288-8
[5] Beavers CJ, Dunn SP, Macaulay TE. The role of angiotensin receptor blockers in patients with angiotensin-converting enzyme inhibitor-induced angioedema. Ann Pharmacother. 2011;45(4):520-524. doi:10.1345/aph.1P630
[6] Makani H, Messerli FH, Romero J, et al. Meta-analysis of randomized trials of angioedema as an adverse event of renin-angiotensin system inhibitors. Am J Cardiol. 2012;110(3):383-391. doi:10.1016/j.amjcard.2012.03.034
[7] Bezalel S, Mahlab-Guri K, Asher I, Werner B, Sthoeger ZM. Angiotensin-converting enzyme inhibitor-induced angioedema. Am J Med. 2015;128(2):120-125. doi:10.1016/j.amjmed.2014.07.011

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

What is the evidence behind the safety of trying an ARB in a patient with a history of angioedema on lisinopril?

Level of evidence

D - Case reports or unreliable data  Read more→



Please see Table 1 for your response.


 

Angiotensin II receptor blockers are safe in patients with prior angioedema related to angiotensin-converting enzyme inhibitors – a nationwide registry-based cohort study

Design

Retrospective cohort study

N= 5,507

Objective

To clarify whether angiotensin II receptor blockers (ARBs) can be used safely in patients with a history of angioedema during angiotensin-converting enzyme inhibitor (ACEi) treatment and to estimate the incidence rate of angioedema in patients subsequently treated with other antihypertensive drugs or no hypertensives

Study Groups

ACEi users (n= 790)

ARB (n= 1,018)

Inclusion Criteria

Patients who experienced a registered episode of angioedema while being treated with an ACEi

Exclusion Criteria

Not explicitly stated

Methods

Three Danish databases were used to identify eligible patients. For patients who had more than one episode of angioedema during ACEi treatment, the first episode registered was identified (index angioedema episode) and was the starting point for subsequent follow-up. All subjects were followed from 30 days after their index episode until any of the following events occurred: a new episode of angioedema, death, emigration or the end of study period. Subjects were allowed to use more than one antihypertensive drug during the follow-up period.

Duration

January 1, 1994 to December 31, 2016

Outcome Measures

Number of angioedema episodes during follow-up, incidence rate of angioedema during follow-up, angioedema following use of different antihypertensive agent

Baseline Characteristics

 

ACEi users (n= 790)

ARBs (n= 1,018)

Median age (interquartile range), years

66 (58 to 74) 67 (59 to 74)

Female

391 (49.5%) 509 (50%)

Results

Endpoint

ACEi (n= 790)

ARBs (n= 1,018)

Number of angioedema episodes during follow-up

127

64

Incidence rate of angioedema during follow-up/1,000 person-years (95% confidence interval [CI])

 61.4 (51.2 to 73.0) 17.9 (13.8 to 22.9)

Propensity score adjusted hazard ratio for angioedema for use of different antihypertensive relative to development of angioedema (95% CI)

1.45 (1.19 to 1.78) 0.39 (0.3 to 0.51)

Adverse Events

N/A

Study Author Conclusions

ARBs can safely replace ACEi in patients who experience angioedema during ACEi treatment. We observed a moderate inverse association between ARBs and angioedema in our selected population. The underlying explanation for this is unknown and a potential focus for future studies.

InpharmD Researcher Critique

Mild cases of angioedema may not have been registered in the databases used; the incidence of angioedema in each group was most likely higher. Additionally, the observational nature of this study cannot exclude the risk of confounding factors.



References:

Rasmussen ER, Pottegård A, Bygum A, von Buchwald C, Homøe P, Hallas J. Angiotensin II receptor blockers are safe in patients with prior angioedema related to angiotensin-converting enzyme inhibitors - a nationwide registry-based cohort study. J Intern Med. 2019;285(5):553-561. doi:10.1111/joim.12867