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J Clin Immunol. 2016 Jan;36(1):95-102. doi: 10.1007/s10875-015-0228-3. Epub 2015 Dec 28.

Angioedema Triggered by Medication Blocking the Renin/Angiotensin System: Retrospective Study Using the French National Pharmacovigilance Database.

Author information

1
Internal Medicine Department, Grenoble University Hospital, Grenoble, France. cfaisant@chu-grenoble.fr.
2
Grenoble Alps University, Grenoble, France. cfaisant@chu-grenoble.fr.
3
Clinique Universitaire de Médecine Interne, CHU de Grenoble, Hopital Michallon CS10217, 38043, Grenoble, Cedex 09, France. cfaisant@chu-grenoble.fr.
4
Internal Medicine Department, Rouen University Hospital, Rouen, France.
5
Internal Medicine Department, Grenoble University Hospital, Grenoble, France.
6
Grenoble Alps University, Grenoble, France.
7
French National Reference Centre for Angioedema (CREAK), Grenoble, France.
8
Inserm-UJF-CEA-CNRS Unit 1036, IRTSV, CEA Grenoble, Grenoble, France.
9
Pharmacovigilance Department, Grenoble University Hospital, Grenoble, France.
10
Inserm U1096, Rouen, France.
11
Pharmacovigilance Department, Lyon University Hospital, Lyon, France.
12
Pharmacovigilance Department, Rouen University Hospital, Rouen, France.

Abstract

INTRODUCTION:

Bradykinin-mediated angioedema (AE) is a rare side effect of some medications, including angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB). In France, side-effects to treatments are reported to the national pharmacovigilance database.

METHODS:

The national MedDRA database was searched using the term "angioedema". Patients were included if they met the clinical criteria corresponding to bradykinin-mediated AE, if their C1-inhibitor levels were normal, and if they were treated with an ACEi or an ARB.

RESULTS:

7998 cases of AE were reported between 1994 and 2013. Among these, 112 met the criteria for bradykinin-mediated AE with normal C1-inhibitor levels. On the 112 drug-AE, patients were treated with an ARB in 21% of cases (24 patients), or an ACEi in 77% of cases (88 patients), in combination with another treatment in 17 cases (mTORi for 3 patients, iDPP-4 for 1 patient, hormonal treatment for 7 patients). ENT involvement was reported in 90% of cases (tongue: 48.2%, larynx: 23.2%). The median duration of treatment before the first attack was 720 days, and the mean duration of attacks was 36.6 h. Forty-one percent (19/46) of patients relapsed after discontinuing treatment.

CONCLUSION:

Angioedema triggered by medication blocking the renin/angiotensin system is rare but potentially severe, with a high risk of recurrence despite cessation of the causative drug.

KEYWORDS:

Angioedema; angiotensin II antagonist; angiotensin converting enzyme inhibitor; bradykinin

PMID:
26707788
DOI:
10.1007/s10875-015-0228-3
[Indexed for MEDLINE]

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