NEW YORK, Nov 10 (Reuters Health) -- A drug used to treat patients with heart disease or high blood pressure, ramipril (sold under the name Altace), can reduce the risk of heart attack, stroke and death by more than 20% in a wide range of patients not traditionally considered to be candidates for the therapy. Moreover, the drug appears to be the first ever to prevent the onset of diabetes in the same patients.
"We consider these results amazing," said study chairman Dr. Salim Yusuf, of McMaster University in Hamilton, Ontario, Canada, in a statement.
"This news gives great hope to everyone with heart disease or those at risk for heart disease, particularly those patients with diabetes," he added.
"Widespread use of this agent would lead to the prevention of 1 to 2 million major cardiovascular events or diabetic events worldwide," Yusuf said at a briefing announcing the results of the Heart Outcomes Prevention Evaluation (HOPE) study. The New England Journal of Medicine released the report on Wednesday, in advance of its publication date, due to its potential importance in treating patients. The study is available on the journal's website, www.nejm.org, and will be published in the journal on January 20, 2000.
More than 9,000 patients from 19 countries in North America, South America, and Europe took part in the 5-year study. The patients were classified by Yusuf and colleagues as "high risk" because they had either vascular disease or diabetes plus one other cardiovascular risk factor, such as high blood pressure, elevated cholesterol or smoking. None of the patients had heart failure, a common reason for treatment with ramipril, one of the ACE inhibitor family of drugs.
Each of the patients received either daily ramipril or (inactive) placebo for the duration of the study.
At the end of the study, only 14% of patients taking ramipril had died or suffered a heart attack or stroke, compared with 17.7% of placebo-treated patients -- a 22% difference. Specifically, ramipril reduced the risk of death from cardiovascular disease by 25%, heart attack by 20%, and stroke by more than 30%.
Ramipril was also associated with fewer cases of heart surgery or procedures in these high-risk patients, decreasing the proportion of patients who required revascularization procedures by 16%. The risks of cardiac arrest, heart failure and complications of diabetes also dropped with ramipril therapy, by 37%, 22% and 16%, respectively.
Moreover, patients on ramipril had 30% lower risk of developing diabetes, making it the first drug ever to be effective in preventing the onset of diabetes, Yusuf said in a teleconference.
"The results are very important," Yusuf said Wednesday at the briefing. The findings extend the benefits of ramipril treatment to a "huge new population... that most of us up to now would not have used ACE inhibitors routinely in." In addition, the study "opens research for new mechanisms of preventing diabetes."
Yusuf speculated that ramipril's effects on diabetes are the result of its mechanism of action in the body, namely blocking the blood-pressure elevating effect of a substance called angiotensin I. If this proves to be the case, other ACE inhibitors may also benefit patients who have diabetes or are at risk for the disease. "I would not be surprised if future studies showed that other ACE inhibitors also have the same effects, but we have to wait for those studies," he said.
In the meantime, the researcher recommends that patients who are using another ACE inhibitor at full dose and are doing well remain on their particular drug. But for new patients, or the "huge new population" of patients who were not previously considered candidates for ACE inhibitors, ramipril would be his first choice.
