The systolic hypertension in the elderly pilot program: Methodological issues*

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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.

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