We conducted a multicenter, double-blind, placebo-controlled randomized trial of aspirin treatment (324 mg in buffered solution daily) for 12 weeks in 1266 men with unstable angina (625 taking aspirin and 641 placebo). The principal end points were death and acute myocardial infarction diagnosed by the presence of creatine kinase MB or pathologic Q-wave changes on electrocardiograms. The incidence of death or acute myocardial infarction was 51 per cent lower in the aspirin group than in the placebo group: 31 patients (5.0 per cent) as compared with 65 (10.1 per cent); P = 0.0005. Nonfatal acute myocardial infarction was 51 per cent lower in the aspirin group: 21 patients (3.4 per cent) as compared with 44 (6.9 per cent); P = 0.005. The reduction in mortality in the aspirin group was also 51 per cent--10 patients (1.6 per cent) as compared with 21 (3.3 per cent)--although it was not statistically significant; P = 0.054. There was no difference in gastrointestinal symptoms or evidence of blood loss between the treatment and control groups. Our data show that aspirin has a protective effect against acute myocardial infarction in men with unstable angina, and they suggest a similar effect on mortality.

The pilot study of the Systolic Hypertension in the Elderly Program was a randomized, double-blind, placebo-controlled trial of drug therapy for isolated systolic hypertension. It followed 551 elderly participants with untreated blood pressures of >160/<90 mm Hg for an average of 34 months. Mean age of the participants was 72 years; 63% were women, and 82% were white. Pretreatment blood pressures averaged 172/75 mm Hg. Participants were randomly assigned to treatment with chlorthalidone or placebo as Step I medication. Blood pressures at annual visits averaged 141/68 and 157/73 mm Hg for the drug-treated and placebo-treated groups, respectively, with 60% and 33% of the survivors on blinded medication having systolic blood pressures of <160 nun Hg at their last annual visit. All-cause mortality rates for the drug-treated and placebo-treated groups were 25.4 and 22.7 deaths per 1,000 participant-years of risk, and rates for definite "first stroke" were 8.3 and 12.8 per 1,000 years of risk. Differences between groups were significant for systolic and diastolic blood pressure but not for death or stroke rates. A full-scale study has begun to determine the effects of drug therapy for isolated systolic hypertension on stroke and mortality rates. (Stroke 1989;20:4-13) I solated systolic hypertension (ISH) is conventionally characterized by systolic blood pressure of a 160 mm Hg and diastolic blood pressure of <90 mm Hg. ISH is rare before the age of 50 years; thereafter, its incidence rises until by the age of 75 years it is present in more than a Received February 3, 1988; accepted August 3, 1988. quarter of Americans. The most important complications of ISH are stroke, left ventricular failure, and myocardial infarction. Together these complications result in a severalfold excess risk of cardiovascular mortality. This excess risk is well established; the major unanswered question with respect to ISH in the elderly is whether available antihypertensive treatment can prevent or delay its catastrophic cardiovascular complications. The pilot study of the Systolic Hypertension in the Elderly Program (SHEP-PS) was undertaken as the first step in seeking an answer to this question. In this randomized, double-blind, placebo-controlled trial, 551 participants 60 years of age or older who had ISH were followed for an average of 34 months. Treatment with diuretic, plus a second antihypertensive agent if needed, was compared with treatment with placebo. The major purpose of SHEP-PS was to test the feasibility of recruitment and the efficacy and acceptability of the treatment regimen. An analysis of the 1-year results demonstrated compliance with the study protocol and control of blood pressure; however, it did not consider the morbid events.

Background. Patients having a cardiac operation frequently require allogeneic blood transfusions despite surgical blood-conservation techniques. Recombinant human erythropoietin (Epoetin alfa) may augment this conservation by stimulating erythropoiesis. The safety and efficacy of perioperative use of Epoetin alfa to reduce the need of allogeneic transfusion was studied.Methods. A multicenter double-blind, placebo-controlled, parallel-group study involved 182 patients having coronary artery bypass grafting and randomized to receive Epoetin alfa (300 or 150 IU/kg) or placebo subcutaneously for 5 days before, on the day of, and for 2 days after operation.Results. Perioperative Epoetin alfa resulted in greater increases in baseline to preoperative hemoglobin levels

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