| “SHEP,” Systolic Hypertension
in the Elderly |
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National Heart, Lung and Blood Institute (NHLBI),
US National Institutes of Health (NIH) |
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Berman Center Co-investigator |
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Richard Grimm, MD, MPH, PhD |
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This national, multi-site study, which was conducted between
1985 and 1991, enrolled 4736 elderly participants (from 447,921
screenees) with systolic hypertension. Participants were randomized
to active drug or placebo and were followed monthly until SBP reached
goal or the maximum level of stepped-care treatment was received.
All participants had quarterly clinic visits for an average of
4.5 years. |
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Role of the Berman Center |
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The Berman Center was one of 14 clinical sites. The Berman Center
enrolled and followed 302 participants; 99% of Berman Center participants
completed the trial. |
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This multi-site, randomized, double-blind, placebo-controlled
trial, was intended to assess the ability of antihypertensive drug
treatment to reduce the risk of nonfatal and fatal (total) stroke
in isolated systolic hypertension. From nearly 450,000 screenees,
4736 participants over 60 years were randomized either to active
treatment or placebo. The step 1 drug was chlorthalidone (dose
1: 12.5 mg/d; dose 2: 25 mg/d) and step 2 drug was atenolol (dose
1: 25 mg/d; dose 2: 50 mg/d). At baseline, average age was 72 years,
57% were women, and 14% were black. Average BP was170 mmHg systolic
and 77 mmHg diastolic. The primary outcome measure was incidence
of total stroke (fatal and nonfatal); secondary outcomes were incidence
of cardiovascular and coronary morbidity and mortality, all-cause
mortality, and quality of life measures. |
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Trial results showed that the 5-year average systolic blood pressure
was 155 mm Hg for the placebo group and 143 mm Hg for the active
treatment group, and the 5-year average diastolic blood pressure
was 72 and 68 mm Hg, respectively. The 5-year incidence of total
stroke was 5.2 per 100 participants for active treatment and 8.2
per 100 for placebo (RR=0.64; p<0.001). The relative risk for
active vs. placebo was 0.73 for clinical nonfatal myocardial infarction
plus coronary death, 0.68 for major cardiovascular events, and
0.87 for all-cause mortality. |
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Investigators concluded that lowering of systolic blood pressure
through pharmacological therapy reduced the combined rate of
fatal and non-fatal stroke by 36% in men and women 60 years of
age and older. The results of this study changed the treatment
of systolic hypertension for millions of senior citizens.
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