Use of antihistamines and risk of ventricular tachyarrhythmia: a nested case-control study in five European countries from the ARITMO project
Poluzzi, Elisabetta; Diemberger, I.; de Ridder, M.; Koci, A.; Clo, M.; Oteri, A.; Pecchioli, S.; Bezemer, I.D.; Schink, T.; Pilgaard Ulrichsen, S.; Boriani, G.; Sturkenboom, M. C.J.; De Ponti, F.; Trifirò, G.
(2017) European Journal of Clinical Pharmacology, volume 73, issue 11, pp. 1499 - 1510
(Article)
Abstract
Purpose: After regulatory restrictions for terfenadine and astemizole in ‘90s, only scarce evidence on proarrhythmic potential of antihistamines has been published. We evaluate the risk of ventricular tachyarrhythmia (VA) related to the use of individual antihistamines. Methods: A matched case-control study nested in a cohort of new users of antihistamines
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was conducted within the EU-funded ARITMO project. Data on 1997–2010 were retrieved from seven healthcare databases: AARHUS (Denmark), GEPARD (Germany), HSD and ERD (Italy), PHARMO and IPCI (Netherlands) and THIN (UK). Cases of VA were selected and up to 100 controls were matched to each case. The odds ratio (OR) of current use for individual antihistamines (AHs) was estimated using conditional logistic regression. Results: For agents largely used to prevent allergic symptoms, such as cetirizine, levocetirizine, loratadine, desloratadine and fexofenadine, we found no VA risk. A statistically significant, increased risk of VA was found only for current use of cyclizine in the pooled analysis (ORadj, 5.3; 3.6–7.6) and in THIN (ORadj, 5.3; 95% CI, 3.7–7.6), for dimetindene in GEPARD (ORadj, 3.9; 1.1–14.7) and for ebastine in GEPARD (ORadj, 3.3; 1.1–10.8) and PHARMO (ORadj, 4.6; 1.3–16.2). Conclusions: The risk of VA associated with a few specific antihistamines could be ascribable to heterogeneity in pattern of use or in receptor binding profile.
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Keywords: Antihistamines, Arrhythmia, Case-control study, Drug safety, Healthcare databases, Pharmacology, Pharmacology (medical)
ISSN: 0031-6970
Publisher: Springer Verlag
Note: Funding Information: Funding The current study is part of the EU-funded ARITMO study which aimed to assess the utilisation and arrhythmogenic potential of anti-infectives, antihistamines and antipsychotics. ARITMO is a Research and Development project funded by the Health Area of the European Commission under the VII Framework Program (FP7/2007-2013), under grant agreement no. 241679-the ARITMO project. Funding Information: Conflict of interest EP, IG, MdR, AK, MC, AO, SP, IB, SPU, FDP, and GT declare no additional support from any organisation. TS is working in departments that occasionally perform studies funded by pharmaceutical industries (Bayer, Celgene, GlaxoSmithKline, Mundipharma, Novartis, Purdue Pharma, Sanofi-Aventis, Sanofi Pasteur MSD and STADA). GB received fees for lectures from Boehringer. MS is heading a research unit that holds unconditional research contracts with some pharmaceutical companies (EliLilly, Pfizer, AstraZeneca), none related to this study. Publisher Copyright: © 2017, Springer-Verlag GmbH Germany.
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