A PHARMACOEPIDEMIOLOGIC STUDY OF TRANDOLAPRIL

In this pharmacoepidemiologic, open-label cohort study, we monitored f or at least 6 months 10,820 patients with hypertension who were prescr ibed trandolapril by their physician. The drug relationships of advers e events (AEs) were assessed by the physician and then by the Knoll-Fr ance Pharmacovigilance Department. All AEs, other than those rated as unlikely to be causally related, mere coded by both the physician and Knell as adverse drug reactions (ADRs). A total of 1217 (11.25%) patie nts reported 1349 AEs of which 1081 (79.10%) were classified as ADRs. ADRs were recorded for 954 (8.82%) patients. After the occurrence of A Es (in 60% of patients, cough was the reason), 529 (4.89%) patients di scontinued treatment. Serious AEs were experienced by 59 (11.2%) patie nts, but only 5 (0.95%) patients experienced serious ADRs. The most fr equently reported ADRs were cough (3.57%), asthenia (1.04%), dizziness (0.92%), headache (0.74%), and nausea (0.55%). Comparison of these re sults with those from a 1049-patient trandolapril longterm, open-label study that was performed for the drug licensing application revealed no differences in the overall nature and frequency of serious or nonse rious AEs.