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Epilepsia. 2017 Aug;58(8):e101-e106. doi: 10.1111/epi.13828. Epub 2017 Jul 6.

Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.

Duke JD1,2, Ryan PB1,3,4, Suchard MA1,5, Hripcsak G1,4, Jin P1,4, Reich C1,6, Schwalm MS1,6, Khoma Y1,7,8, Wu Y1,9, Xu H1,9, Shah NH1,10, Banda JM1,10, Schuemie MJ1,3.

Author information

1
Observational Health Data Sciences and Informatics (OHDSI) Collaborative.
2
Georgia Tech Research Institute, Atlanta, Georgia, U.S.A.
3
Janssen Research and Development, Raritan, New Jersey, U.S.A.
4
Columbia University, New York, New York, U.S.A.
5
University of California Los Angeles, Los Angeles, California, U.S.A.
6
Quintiles-IMS, Cambridge, Massachusetts, U.S.A.
7
Odysseus Data Services Inc, Cambridge, Massachusetts U.S.A.
8
Lviv Polytechnic National University, Lviv, Ukraine.
9
The University of Texas Health Science Center at Houston, Houston, Texas, U.S.A.
10
Center for Biomedical Informatics Research, Stanford University, Stanford, California, U.S.A.

Abstract

Recent adverse event reports have raised the question of increased angioedema risk associated with exposure to levetiracetam. To help address this question, the Observational Health Data Sciences and Informatics research network conducted a retrospective observational new-user cohort study of seizure patients exposed to levetiracetam (n = 276,665) across 10 databases. With phenytoin users (n = 74,682) as a comparator group, propensity score-matching was conducted and hazard ratios computed for angioedema events by per-protocol and intent-to-treat analyses. Angioedema events were rare in both the levetiracetam and phenytoin groups (54 vs. 71 in per-protocol and 248 vs. 435 in intent-to-treat). No significant increase in angioedema risk with levetiracetam was seen in any individual database (hazard ratios ranging from 0.43 to 1.31). Meta-analysis showed a summary hazard ratio of 0.72 (95% confidence interval [CI] 0.39-1.31) and 0.64 (95% CI 0.52-0.79) for the per-protocol and intent-to-treat analyses, respectively. The results suggest that levetiracetam has the same or lower risk for angioedema than phenytoin, which does not currently carry a labeled warning for angioedema. Further studies are warranted to evaluate angioedema risk across all antiepileptic drugs.

KEYWORDS:

Adverse drug reactions; Angioedema; Anticonvulsant hypersensitivity syndrome; Levetiracetam; Observational research; Pharmacovigilance

PMID:
28681416
PMCID:
PMC6632067
DOI:
10.1111/epi.13828
[Indexed for MEDLINE]
Free PMC Article

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