A signal of increased risk of hypoglycaemia with angiotensin receptor blockers caused by confounding.
OBJECTIVE
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).


CONCLUSIONS
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.
Grégoire
Fleur
F
CHU de Bordeaux, Bordeaux, France.
Pariente
Antoine
A
Fourrier-Reglat
Annie
A
Haramburu
Françoise
F
Bégaud
Bernard
B
Moore
Nicholas
N
D016907:Adverse Drug Reaction Reporting Systems; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D016208:Databases, Factual; D005602:France; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D016017:Odds Ratio; D012307:Risk Factors
D047228:Angiotensin II Type 1 Receptor Blockers; D007004:Hypoglycemic Agents