Elisabetta Poluzzi1, I Diemberger2, M De Ridder3, A Koci4, M Clo5, A Oteri3,6, S Pecchioli7,8, I Bezemer9, T Schink10, S Pilgaard Ulrichsen11, G Boriani2,12, M C J Sturkenboom3, F De Ponti4, G Trifirò3,6. 1. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. elisabetta.poluzzi@unibo.it. 2. Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy. 3. Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands. 4. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. 5. Regione Emilia Romagna Health Authority, Bologna, Italy. 6. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy. 7. Health Search, Italian College of General Practitioners, Florence, Italy. 8. Regional Agency for Healthcare Services of Tuscany, Florence, Italy. 9. PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands. 10. Leibniz Institute for Epidemiology and Prevention Research - BIPS, Bremen, Germany. 11. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. 12. Cardiology Division, Department of Diagnostics, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
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 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.
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 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.
Entities:
Keywords:
Antihistamines; Arrhythmia; Case-control study; Drug safety; Healthcare databases
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