REPORTS OF HYPOGLYCEMIA ASSOCIATED WITH THE USE OF ACE-INHIBITORS ANDOTHER DRUGS - A CASE NON-CASE STUDY IN THE FRENCH PHARMACOVIGILANCE SYSTEM DATABASE/

Aims To test the existence of an association between reports of hypogl ycaemia and angiotensin converting enzyme inhibitors, in a spontaneous reports database. Methods The French Pharmacovigilance database was e xamined for an association between adverse drug reaction reports menti oning hypoglycaemia, and angiotensin converting enzyme inhibitors (ACE I) using the case/non-case methodology, with reports of hypoglycaemia as cases and all other reports as comparators. The association between ACEI or other chosen drugs and hypoglycaemia was also tested in the s ubgroups of patients taking or not antidiabetic agents (ADA). Results 428 of 93338 reports mentioned hypoglycaemia (202/2227 with ADA (OR 40 , 95% CI 33-48)). 46/5717 reports mentioned ACEI (OR 1.8 (1.25-2.54)). Other study drugs associated with hypoglycaemia were cibenzoline (OR 80 (57-112)), disopyramide (OR 32 (22-46)), nifedipine (OR 2.16 (1.32- 3.51)), diltiazem (OR 1.76 (1.01-3.06)) nitrates (nitroglycerin, molsi domine) (OR 1.91 (1.16-3.16)) and frusemide (OR 1.89 (1.31-1.76)), but not nicardipine, amlodipine, felodipine or nitrendipine, diazepam, at enolol or combination thiazide diuretics. However, ACEI and other drug s were associated with ADA, so that in the subgroups of patients takin g or not ADA, the association of ACEI with hypoglycaemia disappeared ( OR 0.9 (0.5-1.4) and 1.2 (0.7-2.23, respectively). The same was found for other drugs except cibenzoline. Conclusion The association between reporting of hypoglycaemia and ACE inhibitors was related to concomit ant use of antidiabetic agents. This was true also for other drugs use d in arterial disease or renal failure, such as calcium channel blocke rs, nitrates, and frusemide.