INTOLERANCE RISK-FACTORS FOR THE ACE-INHI BITOR TRANDOLAPRIL - A STUDY ON 30,072 PATIENTS

The aim of the present study was to investigate the incidence of adver se effects and the prognostic value of various risk factors in a large population of unselected hypertensive patients treated with the ACE i nhibitor trandolapril. Among the 30 072 patients investigated in this post marketing retrospective study, 1813 patients (6.0 per cent) repor ted an adverse effect. The five most frequent side effects were coughi ng (3.1 per cent), dizziness (0.7 per cent), headache (0.6 per cent) a sthenia (0.5 per cent) and nausea (0.3 per cent). Intolerance risk fac tors for trandolapril were researched using both univariate and multiv ariate 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 o ccurrence 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 antihypertensive agen ts (OR: 1.27, 95 per cent CI: 1.14-1.41), smoking (OR: 0.76, 95 per ce nt CI: 0.66-0.87) and combination with a beta-blocker (OR: 1.31, 95 pe r cent CI: 1.08-1.58). A prior intolerance oi 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 (ORI 1.61, 9 5 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 CI: 1.03-2.39) appear less significant.