Systolic Hypertension in the Elderly Program, Pilot Study (SHEP-PS): morbidity and mortality experience

SHEP-Pilot Study, a randomized, double-blind, placebo-controlled trial of drug therapy for isolated systolic hypertension, followed 551 participants aged 60 years or more with untreated blood pressures of greater than or equal to 160/less than 90 mmHg for an average of 34 months. Mean age was 72 years, 63% were female and 82% white. Pretreatment blood pressures averaged 172/75 mmHg. As their Step I drug, 443 participants were assigned chlorthalidone and 108 placebo. Of 512 surviving participants, 80% and 84% of the chlorthalidone and placebo groups, respectively, attended their last clinic visit; 71% and 60% were still taking blinded drug; and 60% and 33% had systolic blood pressures less than 160 mmHg. Final blood pressures averaged 140/67 and 154/72 mmHg for the chlorthalidone and placebo groups, respectively. All-cause mortality rates were 25 and 23 deaths per 1000 participant-years of risk, respectively; rates for 'definite' first strokes were 8.3 and 13 deaths. Differences between chlorthalidone and placebo groups were significant for blood pressure but not for event rates.