Sex- and age-related antihypertensive effects of amlodipine. The Amlodipine Cardiovascular Community Trial Study Group.

This community-based study assessed whether there were age, sex, or racial differences in response to amlodipine 5 to 10 mg once daily in patients with mild to moderate essential hypertension. This prospective, open-label trial had a 2-week placebo period, a 4-week upward drug titration/efficacy period, and a 12-week drug maintenance period. There were 1,084 evaluable patients (mean age 55.5 years; 65% men and 35% women; 79% white and 21% black; 75% <65 and 25% > or = 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 mm Hg, (p < or = 0.0001). Amlodipine produced a goal BP response (sitting diastolic BP < or = 90 mm Hg, or a 10 mm Hg decrease) in 86.0% of patients overall. The BP response was greater in women (91.4%) than in men (83.0%, p < or = 0.001), and greater in those > or = 65 years old (91.5%) than in those < 65 years old (84.1%, p < or = 0.01); however, it was similar between whites and blacks (86.0% vs 85.9%, respectively, p = NS). The sex difference in BP response could not be fully explained by differences in age, weight, dose (mg/kg), race, baseline BP, or compliance, and there were no differences among women based on use of hormone replacement therapy. Amlodipine was well tolerated; mild to moderate edema was the most common adverse effect. Thus, amlodipine was effective and safe as once-a-day monotherapy in the treatment of mild to moderate hypertension in a community-based population. Women had a greater BP response to amlodipine.

RCT Entities:   Population Interventions Outcomes