In this pharmacoepidemiologic, open-label cohort study, we monitored for at least 6 months 10,820 patients with hypertension who were prescribed trandolapril by their physician.
The drug relationships of adverse events (AEs) were assessed by the physician and then by the Knoll-France Pharmacovigilance Department.
All AEs, other than those rated as unlikely to be causally related, were coded by both the physician and Knoll as adverse drug reactions (ADRs).
A total of 1217 (11.25%) patients reported 1349 AEs of which 1081 (79.10%) were classified as ADRs.
ADRs were recorded for 954 (8.82%) patients.
After the occurrence of AEs (in 60% of patients, cough was the reason), 529 (4.89%) patients discontinued treatment.
Serious AEs were experienced by 59 (11.2%) patients, but only 5 (0.95%) patients experienced serious ADRs.
The most frequently reported ADRs were cough (3.57%), asthenia (1.04%), dizziness (0.92%), headache (0.74%), and nausea (0.55%). Comparison of these results with those from a 1049-patient trandolapril long-term, open-label study that was performed for the drug licensing application revealed no differences in the overall nature and frequency of serious or nonserious AEs.
Mots-clés Pascal : Trandolapril, Antihypertenseur, Chimiothérapie, Hypertension artérielle, Traitement, Toxicité, Homme, Inhibiteur angiotensin converting enzyme, Pharmacovigilance, Etude cohorte, Epidémiologie, France, Europe
Mots-clés Pascal anglais : Trandolapril, Antihypertensive agent, Chemotherapy, Hypertension, Treatment, Toxicity, Human, ACE inhibitor, Pharmacovigilance, Cohort study, Epidemiology, France, Europe
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0520197
Code Inist : 002B02F05. Création : 13/02/1998.