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
R. Tiebel et al., 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, Current therapeutic research, 59(6), 1998, pp. 325-340
Citations number
26
Categorie Soggetti
Pharmacology & Pharmacy","Medicine, Research & Experimental
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.