This community-based study assessed whether there were age, sex, or ra
cial differences in response to amlodipine 5 to 10 mg once daily in pa
tients with mild to moderate essential hypertension. This prospective,
open-label trial had a 2-week placebo period, a 4-week upward drug ti
tration/efficacy period, and a 12-week drug maintenance period. There
were 1,084 evaluable patients (mean age 55.5 years; 65% men and 35% wo
men; 79% white and 21% black; 75% < 65 and 25% greater than or equal t
o 65 years old). At the end of the titration/efficacy phase, the mean
+/- SD blood pressure (BP) decreased by -16.3 +/- 12.3/-12.5 +/- 5.9 m
m Hg, (p less than or equal to 0.0001). Amlodipine produced a goal BP
response (sitting diastolic BP less than or equal to 90 mm Hg, or a 10
mm Hg decrease) in 86.0% of patients overall. The BP response was gre
ater in women (91.4%) than in men (83.0%, p less than or equal to 0.00
1), and greater in those greater than or equal to 65 years old (91.5%)
than in those < 65 years old (84.1%, p less than or equal to 0.01); h
owever, it was similar between whites and blacks (86.0% vs 85.9%, resp
ectively, p = NS). The sex difference in BP response could not be full
y explained by differences in age, weight, dose (mg/kg), race, baselin
e BP, or compliance, and there were no differences among women based o
n use of hormone replacement therapy. Amlodipine was well tolerated; m
ild to moderate edema was the most common adverse effect. Thus, amlodi
pine was effective and safe as once-a-day monotherapy in the treatment
of mild to moderate hypertension in a community-based population. Wom
en had a greater BP response to amlodipine.