This randomized, single-blinded, placebo-controlled study was performed to
evaluate antihypertensive efficacy and tolerability of the angiotension-con
verting enzyme (ACE) inhibitor ramipril in patients with isolated systolic
hypertension (ISH). ISH is a common finding in the elderly population and i
t is considered to be an important cardiovascular risk factor. After a 3-we
ek mash-out, 84 patients aged between 65 and 86 years, with ISH defined as
systolic blood pressure (SBP), greater than 160 mm Hg and diastolic blood p
ressure (DBP) less than 90 mm Ng, mere randomized to placebo (r = 40) or ra
mipril (n = 44) at the initial dose of 2.5 mg/day, which after 3 weeks of t
reatment, was increased to 5 mg/day for another 9 weeks when SEP was greate
r than 160 mm Hg or SEP decrease was less than 20 mm Hg. At baseline, the t
wo groups were well matched for age, body weight, DBP, SEP, and heart rate.
A total of 40 patients in the treated group and 34 controls completed the
study. In the ramipril group, SEP decreased in a statistically significant
manner from 180.5 to 168.1 (p ( 0.05) after 3 weeks and to 162.1 mm Hg (p <
0.02) after 12 weeks. In the placebo group, SBP decreased without statisti
cal significance (p < 0.05) from 178.1 to 172.8 after 3 weeks and to 168.9
mm Hg after 12 weeks. Comparison between groups was statistically significa
nt (p < 0.05) at twelve weeks. Patients' "responder" rate was 19.5% versus
46.3% after 3 weeks (p = 0.025) and 32.4% versus 70.0% after 12 weeks OI =
0.003) in the placebo and ramipril group, respectively. No effect was obser
ved on DBP and heart rate and similar tolerability was seen in each group.
The results of this placebo-controlled study underline the clinical efficac
y, tolerability, and safety of ramipril for the treatment of elderly patien
ts with ISH.