SAFETY AND TOLERABILITY OF LOSARTAN POTASSIUM, AND ANGIOTENSIN-II RECEPTOR ANTAGONIST, COMPARED WITH HYDROCHLOROTHIAZIDE, ATENOLOL, FELODIPINE ER, AND ANGIOTENSIN-CONVERTING ENZYME-INHIBITORS FOR THE TREATMENTOF SYSTEMIC HYPERTENSION

This report presents data on the safety and tolerability of losartan p otassium (losortan), a selective antagonist of the angiotensin II AT-1 receptor, in approximately 2,900 hypertensive patients treated in dou ble-blind clinical trials. In these studies headache (14.1%), upper re spiratory infection (6.5%), dizziness (4.1%), asthenia/fatigue (3.8%), and cough (3.1%) were the clinical adverse experiences most often rep orted in patients treated with losartan. These adverse experiences wer e also frequently reported in patients receiving placebo: 17.2%, 5.6%, 2.4%, 3.9%, and 2.6%, respectively. Dry cough as an adverse event was reported in 8.8% of patients treated with angiotensin-converting enzy me inhibitors, and in 3.1% and 2.6% of patients treated with losartan or placebo, respectively. Only dizziness was considered ''drug-related '' more often in losartan-treated (2.4%) than placebo-treated (1.3%) p atients. In controlled clinical trials, losartan was better tolerated than other antihypertensive agents as determined by the incidence of p atients reporting any drug-related adverse experiences. Rates of disco ntinuation due to clinical adverse experiences in patients who receive d losartan monotherapy or losartan + hydrochlorothiazide were 2.3% and 2.8%, respectively, compared with placebo (3.7%). No laboratory adver se experiences were unexpected or of clinical importance. First-dose h ypotension rarely occurred with losartan or with losartan plus hydroch lorothiazide, and withdrawal effects such as rebound hypertension were not observed in clinical trials. There were no clinically important d ifferences in the clinical or laboratory safety profiles in the demogr aphic subgroups for age, gender, or race, In controlled clinical trial s, losartan demonstrated on excellent tolerability profile.