A pharmacoepidemiologic study of trandolapril
- 作者：Jouglard ; Jacqueline ; Hamel ; Jean-Dominique ; Juvin ; Philippe
- 关键词：pharmacoepidemiology ; pharmacovigilance ; trandolapril ; cohort study ; postmarketing surveillance
- 刊名：Current Therapeutic Research
- 出版年：1997
- 期刊代码：75_0011393x
- 类别：med
- 出版时间：September, 1997
- 卷：58
- 期：9
- 页码：555-563
- 文件大小：646 K
摘要
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.