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High Hopes for Blood Pressure Drug for Preventing Heart Attack, Stroke

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Nov. 10, 1999 (Atlanta) -- International researchers presented, for the first time in the U.S., the final results of a large clinical trial that's expected to revolutionize the way physicians manage heart disease. The Heart Outcomes Prevention Evaluation (HOPE) trial showed that the blood pressure medication Altace (ramipril) significantly reduces incidence of death, heart attacks, and strokes in high-risk patients. Due to the therapeutic implications of the findings, presented here Wednesday at the American Heart Association's 72nd Scientific Sessions, The New England Journal of Medicine released the study results nine weeks ahead of publication schedule.

"With [Altace], we had very clear results of a reduction of cardiovascular death, strokes, and [heart attacks]," says study chairman Salim Yusuf, MD, of McMaster University in Hamilton, Ontario. The researchers also found a decreased need for balloon angioplasty and heart bypass surgery as well as less kidney failure in diabetics.

Conducted at 237 international centers, the study involved more than 9,000 men and women with heart disease and diabetes. All were 55 years or older, with at least one additional risk factor for heart disease or strokes such as smoking, high blood pressure, or low HDL ('good' cholesterol) levels, but without a history of heart failure or serious heart valve disease. Participants were assigned to receive daily doses of either 10 mg of Altace, 400 IU of vitamin E, or a placebo, for five years. Researchers wanted to know how many patients experienced heart attacks, heart failure, or strokes, or whether they died from any of these causes.

Overall, Altace lowered the risk of death due to heart disease or stroke by 25%. Significantly more people who received the placebo rather than the Altace suffered heart attack, stroke, or death. According to Yusuf, these results were consistent in all the patients regardless of if they had high blood pressure or not. Everyone in the study tolerated the drug well, experiencing no major side effects.

Says HOPE trial co-chairman Peter Sleight, MD, of the University of Oxford and John Radcliffe Hospital in England, "An analysis is coming out shortly, and I will eat my hat if [Altace] is not really cost-effective."

This trial is the first to strongly suggest that ACE inhibitors, the class of blood pressure medications to which Altace belongs, have effects on the lining of blood vessels and prevents the rupture of cholesterol plaques that leads to a heart attack or stroke, according to Sleight. Although half the subjects had high blood pressure, he says, "they were under good control [at the beginning of the study]." Altace's modest effect on these patients' blood pressure "would not account for more than a quarter of the benefit seen in [heart attack] reduction," he says.

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