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Efficacy and safety of losartan.

Losartan potassium (losartan) is the first of a new class of antihypertensive agents that specifically blocks the type 1 angiotensin II receptor. The efficacy and safety of losartan have been assessed in double-blind, controlled clinical trials conducted in approximately 3700 patients with uncomplicated mild, moderate and severe essential hypertension. Overall, losartan, whether administered alone or in combination with a low dose of hydrochlorothiazide (HCTZ), was effective and well-tolerated in these clinical trials, with an incidence of adverse experiences similar to that of placebo. The antihypertensive effects of losartan 50 mg once daily were similar to those of 20 mg once daily of the angiotensin-converting enzyme (ACE) inhibitor enalapril. The antihypertensive effects of losartan 50 to 100 mg once daily were similar to those of the calcium channel blocker felodipine 5 to 10 mg and to those of the beta-adrenergic blocker atenolol 50 to 100 mg once daily. Losartan was shown to have a smooth antihypertensive profile throughout the 24 h period following dosing, which mirrors the diurnal variability of blood pressure. The addition of 12.5 mg HCTZ to 50 mg losartan produced an additional significant antihypertensive response. There were no clinically meaningful differences in the antihypertensive effect of losartan when assessed by demographic subgroups of age or sex; there is a smaller antihypertensive response in Black patients. The most common patient-reported, drug-related, clinical adverse experience, with an incidence greater than that of placebo, was dizziness (2.4% versus 1.3%). The overall rate of patient withdrawal from losartan therapy due to clinical adverse experiences was lower than that of placebo (2.3% versus 3.7%).(ABSTRACT TRUNCATED AT 250 WORDS)