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A signal of increased risk of hypoglycaemia with angiotensin receptor blockers caused by confounding
Author(s) -
Grégoire Fleur,
Pariente Antoine,
FourrierReglat Annie,
Haramburu Françoise,
Bégaud Bernard,
Moore Nicholas
Publication year - 2008
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2008.03176.x
Subject(s) - pharmacovigilance , confounding , medicine , odds ratio , pharmacoepidemiology , confidence interval , pharmacology , drug , medical prescription
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Spontaneous reporting is a valuable way to provide early detection for safety signals related to drug use. • Due to the increasing size of pharmacovigilance databases, data‐mining and other automated methods for signal generation are more and more often used. • Even if these methods are very useful, they do not allow, for every particular association, an automated exploration of the multiple sources of confounding. WHAT THIS STUDY ADDS • An association between angiotensin receptor blockers use and hypoglycaemia was found in the French pharmacovigilance database. • This signal disappeared after stratification on antidiabetic drug use, suggesting confounding by indication. • The association between hypoglycaemia and angiotensin receptor blocker use was actually less than expected in concomitant antidiabetic drug users. AIMS To study reporting of hypoglycaemia in angiotensin receptor blocker (ARB) users, and to investigate the possibility of confounding. METHODS The French pharmacovigilance database was examined for an association between hypoglycaemia and ARBs or other drugs using reports notified between 1996 and 2005. This association was also tested in patients taking or not taking antidiabetic agents (ADAs) using reporting odds ratios (ROR). RESULTS Hypoglycaemia was mentioned in 807 of the 174 595 reports entered during the study period. Overall hypoglycaemia was associated with the use of ARBs [ROR 2, 95% confidence interval (CI) 1, 3] and with the use of ADAs (ROR 32, 95% CI 27, 37). Moreover, the use of ARBs was associated with the use of ADAs (OR 7, 95% CI 6, 8). Considering separately reports with and without ADA, the association of ARB use with a higher risk of hypoglycaemia disappeared (OR 0.4, 95% CI 0.2, 0.8 and OR 2, 95% CI 1, 3, respectively). CONCLUSION A signal indicating an association between ARB use 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 ARB use and hypoglycaemia was negative in ADA users.