EFFICACY AND SAFETY OF LOSARTAN

Losartan potassium (losartan) is the first of a new class of antihyper tensive agents that specifically blocks the type I angiotensin II rece ptor. The efficacy and safety of losartan have been assessed in double -blind, controlled clinical trials conducted in approximately 3700 pat ients with uncomplicated plicated mild, moderate and severe essential hypertension. Overall, losartan, whether administered alone or in comb ination with a low dose of hydrochlorothiazide (HCTZ), was effective a nd well-tolerated in these clinical trials, with an incidence of adver se experiences similar to chat of placebo, The antihypertensive effect s of losartan 50 mg once daily were similar to those of 20 mg once dai ly of the angiotensin-converting enzyme (ACE) inhibitor enalapril. The antihypertensive effects of losartan 50 to 100 mg once daily were sim ilar to those of the calcium channel blocker felodipine 5 to 10 mg and to those of the beta-adrenergic blocker 50 to 100 mg once daily, Losa rtan was shown to have a smooth antihypertensive profile throughout th e 24 h period following dosing, which mirrors the diurnal variability of blood pressure. The addition of 12.5 mg HCTZ to 50 mg losartan prod uced an additional significant antihypertensive response. There were n o 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 commo n patient reported, drug-related, clinical adverse experience, with an incident greater than that of placebo, was dizziness (2.4% versus 1.3 %). The overall rate of patient withdrawal from losartan therapy due t o clinical adverse experiences was lower adverse experiences was lower than that of placebo (2.3% versus 3.7%) The incidence of spontaneousl y reported cough with losartan (3.1%) and losartan plus HCTZ (2,6%) wa s similar to that observed with placebo (2.6%) but less than that foun d with the ACE inhibitors (8.8%). Laboratory test abnormalities were r arely associated with were Losartan administration. Hyperkalemia was o bserved in 1.5% of patients treated en with losartan monotherapy. This was comparable with that seen in patients treated with the ACE inhibi tors (1.3%) and did not necessitate discontinuation of therapy. The ov erall conclusion from the results of these studies is that losartan pr oduces clinically meaningful decreases in blood pressure, has excellen t safety and tolerability profiles and has a decreased incidence of so me side effects, such as cough, which are associated with other classe s of antihypertensive drugs.