[Risk factors of adverse effects of angiotensin-converting enzyme inhibitors. Apropos of 30,072 patients treated by trandolapril].
The aim of the present study was to investigate the incidence of adverse effects and the prognostic value of various risk factors in a large population of unselected hypertensive patients treated with the ACE inhibitor trandolapril. Among the 30 072 patients investigated in this post marketing retrospective study, 1813 patients (6.0 per cent) reported an adverse effect. The five most frequent side effects were coughing (3.1 per cent), dizziness (0.7 per cent), headache (0.6 per cent) asthenia (0.5 per cent) and nausea (0.3 per cent). Intolerance risk factors for trandolapril were researched using both univariate and multivariate analysis. In the univariate analysis, a prior intolerance of an ACE inhibitor and female gender were strongly correlated with either overall intolerance or coughing. The most relevant variables for the occurrence of adverse effects, listed according to their entry order in the multivariate analysis, were: prior intolerance of ACE inhibitors (OR: 4.19, 95 per cent CI: 3.66-4.78), female gender (OR: 1.46, 95 per cent CI: 1.31-1.63), prior intolerance of other antihpertensive agents (OR: 1.27, 95 per cent CI: 1.14-1.41), smoking (OR: 0.76, 95 per cent CI: 0.66-0.87) and combination with a beta blocker (OR: 1.31, 95 per cent CI: 1.08-1.58). A prior intolerance of an ACE inhibitor appears to be a very strong predictor of coughing (OR: 6.14, 95 per cent CI: 5.24-7.19). The following variables, namely female gender (OR: 1.61, 95 per cent CI: 1.40-1.85), age 60-80 (OR: 1.25, 95 per cent CI: 1.09-1.44) and prior intolerance of other antihypertensive agents (OR: 1.20, 95 per cent CI: 1.03-2.39) appear less significant.
Vaur
L
L
Laboratoires Roussel, Direction Médicale, Tour Roussel Hoechst, Paris La Défense, France.
Genès
N
N
Chambrelan
F
F
Dutrey-Dupagne
C
C
Pochoy
A
A
Elkik
F
F
Rauss
A
A
D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007211:Indoles / Q000009:adverse effects*; D008875:Middle Aged; D015999:Multivariate Analysis; D011358:Product Surveillance, Postmarketing; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D007211:Indoles; C052035:trandolapril