Copyright © 1988 by the European Society of Cardiology.
© 1988 The European Society of Cardiology
The systolic hypertension in the elderly pilot program: Methodological issues*
,
Bowman Gray School of Medicine Winston-Salem, NC, U.S.A.
Department of Epidemiology and International Health, University of California San Francisco, CA, U.S.A
address for correspondence: Curt D. Furberg, M.D., bowman Gray School of Medicine, Winston-Salem, NC 27103, U.S.A
Abstract
The Systolic Hypertension in the Elderly Program (SHEP) Pilot Study was conducted to determine the feasibility of conducting a long-term placebo-controlled randomized clinical trial in elderly subjects. Enrolled in the study were 551 men and women between the ages of 60 and 90 years with isolated systolic hypertension (SBP
160 mmHg and DBP < 90 mmHg). The study showed that it is possible to recruit old and very old subjects into a clinical trial; the elderly are good compliers (drugs and follow-up visits), with some decline after the age of 80; control of blood pressure was accomplished in the large majority of patients; evaluation of side effects represents a potential problem as varied complaints increase with age thus creating difficulties in distinguishing those attributed to the study drug; and finally, cause-specific mortality is probably preferable to all-cause mortality as an end-point in prevention trials of antihypertensive regimens.
Key Words: Isolated systolic hypertension elderly antihypertensive agents clinical trial
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