Poster Presentations
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ABSTRACTS
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Poster Presentations P.055 More or Less Risk of Hypoglycaemia in Users of Angiotensin Receptor Antagonists? A Study of Spontaneous Reporting F. Gregoire,3 A. Pariente,1,2,3 F. Haramburu,1,3 N. Moore1,2,3 1 INSERM U657, Bordeaux, France; 2 Universite Bordeaux 2, Bordeaux, France; 3 CHU de Bordeaux, Bordeaux, France Background: Angiotensin converting enzyme inhibitors (ACEI) have been associated with hypoglycaemia, which may have been related to higher prescription in diabetics. The same could be true for angiotensin receptor antagonists (ARA), although there is no publication supporting this hypothesis at the moment. Objective: To study the risk of reporting hypoglycaemia in angiotensin receptor antagonists (ARAs) users, and to investigate the possibility of confounding. Methods: The French Pharmacovigilance database was examined for an association between reports of hypoglycaemia and ARA, using the casenon case method. The association between ARAs or other drugs and hypoglycaemia was also tested in patients taking or not antidiabetic agents (ADAs). Results: Among all 174595 reports, 807 mentioned hypoglycaemia. This was the case for 299 of the 3469 reports with ADAs (OR 31.7, 95% CI 27.4-36.7) and for 33 of the 4153 reports with ARAs (OR 1.8, 95% CI 1.2-2.5). Other drugs associated with hypoglycaemia were angiotensin converting enzyme inhibitors (ACEIs) (OR 3.3, 95% CI 2.4-4.2), disopyramide (OR 17.4, 95% CI 10.4-29.1), cibenzoline (OR 107.3, 95% CI 78-148), atenolol (OR 2.1, 95% CI 1.4-3.4), dihydropyridines (OR 1.9, 95% CI 1.3-3.0), frusemide (OR 2.8, 95% CI 2.3-3.5), but not diazepam, verapamil or combination thiazide diuretics. However, ARA and other drugs were associated with ADA, so that in the subgroups of patients taking or not ADA, the association of ARA with hypoglycaemia disappeared (OR 0.4, 95% CI 0.2-0.8 and OR 1.5, 95% CI 0.8-2.9, respectively). In fact, ARA was negatively associated with hypoglycaemia in patients using antidiabetics. Conclusion: A signal indicating an association between ARA and hypoglycaemia was found in the French pharmacovigilance database. This signal disappeared after stratification on ADA use, thus suggesting confounding by indication. Moreover, the association between ARA use and the occurrence of hypoglycaemia was negative in ADA users, whereas it was positive in the whole database, a typical case of Simpson’s paradox.
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