A substantial number of older hypertensive patients have stage 1 isolated s
ystolic hypertension (systolic blood pressure between 140 and 159 mm Hg and
diastolic blood pressure < 90 min Hg), but there are currently no data sho
wing that drug treatment is effective, safe, and/or beneficial. To compare
the effects of active treatment compared with placebo on blood pressure, le
ft ventricular hypertrophy, and quality of life among older stage 1 isolate
d systolic hypertensive patients, a randomized, double-blind, parallel-grou
p, multicenter clinical trial comparing felodipine (2.5. 5, or 10 mg once d
aily) and matching placebo was performed in 171 patients (49% male, average
age 66 +/-7 years, with 49% white and 30% Hispanic) with a baseline blood
pressure of 149 +/-7/83 +/-6 mm Fig. During 52 weeks of treatment, patients
randomized to active treatment achieved significantly lower blood pressure
s (137.0 +/- 11.7/80.2 +/-7.6 mm Hg for extended-release felodipine versus
147.5 +/- 16.0/83.5 +/-9.7 mm Hg for placebo, P <0.01 for each), a reduced
incidence of left ventricular hypertrophy (7% for extended release felodipi
ne versus 24% for placebo, P <0.04), and improved quality of life (change i
n Psychological General Well-Being index, 3.0 +/-6.8 for extended-release f
elodipine versus -0.8 +/- 10.3 for placebo, P <0.01) versus baseline. There
were no clinically significant differences between treatments in tolerabil
ity or adverse effects. Stage 1 isolated systolic hypertension can be effec
tively and safely treated pharmacologically. Treatment reduced progression
to the higher stages of hypertension, reduced the incidence of left ventric
ular hypertrophy, and improved an overall measure of the quality of life. L
arger and longer studies will be needed to document any long-term reduction
in cardiovascular event rates associated with treating stage 1 systolic hy
pertension.