EFFICACY, SAFETY, AND EFFECTS ON HYPERTENSION-ASSOCIATED SYMPTOMS OF LOSARTAN, ALONE OR IN COMBINATION WITH HYDROCHLOROTHIAZIDE, VERSUS AMLODIPINE IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

This randomized, double-masked, multicenter, clinical study with three parallel treatment groups was conduct ed to compare the efficacy and tolerability of losartan potassium (losartan), alone or combined with hydrochlorothiazide (HCTZ), and amlodipine in patients with mild-to-mo derate hypertension. A g-week placebo period was followed by a 12-week treatment period. A total of 935 patients were randomized to 3 treatm ent regimens: losartan 50 mg once daily with a possible increase to 10 0 mg once daily (L 50/100, n = 308), losartan 50 mg once daily with a possible addition of HCTZ 12.5 mg once daily (L/HCTZ, n = 313), or aml odipine 5 nag once daily with a possible increase to 10 mg once daily (A 5/10, a = 314) at week 6. Approximately 50% of the patients in each treatment; group required a dose adjustment because of inadequate res ponse. At the end of the study the reductions in mean trough sitting d iastolic blood pressure (SiDBP) were -11.4 mm Hg, -13.2 mm Hg, and -13 .6 mm Hg in the L 50/100, L/HCTZ, and A 5/10 treatment groups, respect ively. Reductions in mean trough sitting systolic blood pressure (SiSB P) were similar in all treatment groups. Blood pressure reductions (Si SBP/ SiDBP) were comparable in the two subgroups without dose adjustme nt (-18.6 mm Hg/-14.2 mm Hg for losartan 50 mg and -19.0 mm Hg/-14.8 m m Hg for amlodipine 5 mg) during the 12-week treatment period. Differe nces between the treatment groups In patient-reported symptoms were si gnificant, with a higher rate of swelling and edema reported with amlo dipine (10%) than with losartan (3%). In this study, losartan appeared to be as effective as amlodipine and to have fewer drug-related side effects.