SAFETY AND TOLERABILITY OF LOSARTAN COMPARED WITH ATENOLOL, FELODIPINE AND ANGIOTENSIN-CONVERTING ENZYME-INHIBITORS

Aim: To examine the safety profile and tolerability of losartan potass ium (losartan), a selective antagonist of the angiotensin II type 1 (A T(1)) receptor. Patients and methods: Approximately 2000 hypertensive patients were treated in double-blind clinical trials with losartan, p lacebo or other antihypertensive drug classes. Results: Headache (14.1 %), upper respiratory infection (6.5%), dizziness (4.1%), asthenia/fat igue (3.8%) and coughing (3.1%) were the most commonly reported clinic al adverse experiences in patients treated with losartan. These advers e experiences were also commonly reported in patients treated with a p lacebo: 17.2, 5.6, 2.4, 3.9 and 2.6%, respectively. A dry cough was re ported by 8.8% of patients treated with angiotensin converting enzyme (ACE) inhibitors, statistically greater than that reported in patients treated with losartan and placebo, 3.1 and 2.6%, respectively (P < 0. 001, losartan versus ACE inhibitors). Only dizziness was more often co nsidered drug-related in losartan-treated patients (2.4%) than in pati ents who received placebo (1.3%). In controlled clinical trials, losar tan was better tolerated than other antihypertensive agents as determi ned by the incidence of patients reporting any drug-related adverse ex periences. The rate of withdrawal due to clinical adverse experiences in patients treated with losartan was 2.3% compared to 3.7% in patient s treated with a placebo. No adverse laboratory results were unexpecte d or of clinical importance. First-dose hypotension occurred rarely wi th losartan, and withdrawal effects such as rebound hypertension were not observed in clinical trials. There were no clinically important di fferences in the clinical or laboratory safety profiles for the demogr aphic subgroups of age, sex or race. Conclusion: In controlled clinica l trials losartan has demonstrated an excellent tolerability profile.