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Ramipril Reduces Stroke Risk, HOPE Trial Follow-up Reports: Presented at ISC

By Bruce Sylvester

Special to DG News

SAN ANTONIO, TX -- February 11, 2002 -- Ramipril appears to significantly reduce the risk of stroke in patients with normal or controlled blood pressure levels who are at high risk of cardiovascular events, according to data from the Heart Outcomes Prevention Evaluation (HOPE).

Researchers reported the late-breaking clinical trial data here on Feb. 9 during the International Stroke Conference.

"HOPE was a major international study, and the primary results were presented at two major medical meetings in 1999. What is new today is a report on the secondary data specifically related to stroke outcome," said Jeffrey Probstfield, MD, professor of medicine at the University of Washington, in Seattle, Washington.

HOPE was a randomized, placebo-controlled trial with a 2x2 factorial design. Researchers enrolled 9,297 subjects 55 years or older who showed evidence of vascular disease or diabetes and at least one other cardiovascular risk factor. The study was conducted at 267 medical centers around the world. Patients were treated for hypertension prior to final acceptance as subjects, and those with uncontrolled hypertension were not enrolled.

The researchers analyzed the collected data and determined stroke by using computed tomography scan, magnetic resonance or, where these data were not available, the persistence of stroke symptoms for over 24 hours. They also diagnosed transient ischemic events and evaluated the data for changes in cognition and function. The investigators followed each subject for an average of 4.5 years.

Ramipril therapy versus placebo reduced the risk of stroke in the study population by 32 percent (156 vs. 226 respectively; p=0.0002) and the risk of fatal stroke by 61 percent (17 vs. 22 respectively). The benefits of ramipril therapy were consistent across baseline blood pressure levels, use of particular medications and in subgroups defined by the presence or absence of prior strokes, coronary heart disease, peripheral artery disease, diabetes or hypertension. The results of ramipril therapy were evident even with a moderate reduction in mean blood pressure (3.8 mm Hg/2.8 mm Hg).

"HOPE represents very clearly a new paradigm in terms of the reduction of cardiovascular events, including stroke," Dr. Probstfield said. "The reason I say that is that in previous cardiovascular trials we've aimed at reducing blood pressure or cholesterol, changing smoking behaviors or other specific risk factors. The attempt here was to provide vascular protection in a more general sense than aiming at one risk factor."

"Hope was not a blood pressure reduction trial," he said. "People were admitted to HOPE having had their blood pressure treated ahead of time. Over half of the subjects had overtly normal blood pressures at the outset of the study. Three-quarters had readings at less than 150 over 80 [mm Hg]. The blood pressure reductions in the trial were modest. With a 20 percent reduction in myocardial infarction and a 32 percent reduction in stroke in patients using ramipril, we were very interested in how this worked."

"It looks like there was a vascular protection effect occurring that could not be attributed to the lowering of blood pressure," the researcher said. "The exact operation of this protective effect of ramipril therapy remains open to further study."

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