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April 18, 2000
News this month Ramipril, an ACE inhibitor that has been prescribed for several years for the treatment of high blood pressure, has now been shown to reduce the risk of heart attack, stroke and bypass surgery, as well as diabetes and its complications in those who have heart disease. Ramipril, an ACE inhibitor…, has
now been shown to reduce the risk of heart attack, stroke and bypass
surgery, as well as diabetes…in those who have heart disease.
The Heart Outcomes Prevention Evaluation (HOPE), published in the January 20 issue of The New England Journal of Medicine, was conducted among 9,297 men and women with diabetes or heart or blood vessel disease who did not have heart failure. Diabetic participants in the study also had at least one risk factor for heart disease or stroke such as elevated cholesterol, high blood pressure or cigarette smoking. The dramatic 30 percent drop in the development of diabetes was considered a significant benefit because individuals with diabetes are significantly more likely to die from heart attacks and strokes. Subjects who took ramipril were 25%
less likely to die from any cardiovascular cause, 20% less likely
to have a heart attack, 31% less likely to have a stroke and 30%
less likely to become diabetic.
The study was carried out in 129 medical centers across the U.S., Canada, Mexico and South America. Subjects took either ramipril or a placebo for five years. Compared to the placebo group, subjects who took ramipril were 25 percent less likely to die from any cardiovascular cause, 20 percent less likely to have a heart attack, 31 percent less likely to have a stroke and 30 percent less likely to become diabetic than those on standard drug therapies. Dr. Salim Yusuf of McMaster University in Ontario, the study’s lead author, said ramipril’s benefits were at least as large as other drugs such as aspirin, beta-blockers and cholesterol- reducing drugs. "In the study, ramipril was taken in conjunction with these other drugs, not as a substitute for them," he said. The benefits began to be apparent in subjects about a year after beginning ramipril. "A statistical analysis suggested longer term treatment might yield even better results," said Dr. Yusuf. Side effects include persistent cough, dizziness and low blood pressure. The study was stopped ahead of schedule in March 1999 because a safety monitoring committee found a clear benefit for ramipril in a preliminary review. NEJM editors found the findings so important they announced the study’s results two months before its publication. "Widespread use of this agent could lead to the prevention
of one to two million major cardiovascular events or diabetic events
worldwide every year," Dr. Yusuf said.
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Ramipril offers measurable benefits to many patients The HOPE study will make a dramatic difference in how we care for millions of people with cardiovascular disease. The ACE inhibitor ramipril was shown to benefit a broad range of patients–men and women of various ages, with and without diabetes, and those already taking other cardiovascular medications such as aspirin, cholesterol- lowering drugs and blood-pressure reducing drugs. "ACE inhibitors help prevent
the progressive reduction in heart function and heart enlargement
found in patients with heart damage from heart attacks or heart
failure."
Over the last three decades we have learned from several large studies that ACE inhibitors help prevent the progressive reduction in heart function and heart enlargement found in patients with heart damage from heart attacks or heart failure. Patients who took ACE inhibitors in these studies also had fewer heart attacks while taking the drugs, raising the possibility this class of drugs somehow affected the process of arterial disease. How do ACE inhibitors work? HOPE study benefits go beyond blood pressure control "The results were dramatic.
For every 1,000 patients who took ramipril, the study found 70
would avoid 150 serious problems…"
The results were dramatic. For every 1,000 patients who took ramipril, the study found 70 would avoid 150 serious problems, including heart attacks, strokes, the need for bypass surgery and death. Diabetic complications, which usually occur because of impaired arterial blood flow, were reduced by 16 percent. These benefits exceed what would be expected from blood pressure reduction alone. The average drop in blood pressure was very modest. In fact, ramipril’s benefits were realized in patients with various blood pressure levels, including those in the normal range. The development of diabetes appears to have been reduced by 32 percent. There were no significant differences among patients taking vitamin E. Are these benefits unique to ramipril or would any ACE inhibitor achieve the same results? Other medical investigations such as the Captopril Prevention Study and the STOP Hypertension-2 have shown similar benefits. It’s too soon to know whether ramipril offers unique benefits. Until conclusive evidence exists, the jury’s out. The bottom line My approach with patients is first: stop smoking. This remains
the biggest risk factor. Second, if their cholesterol levels are
high, I would prescribe cholesterol-lowering drugs. And then to
reduce blood pressure and possibly delay the development of heart
failure, I would prescribe either beta blockers or ACE inhibitors.
Patients are often disconcerted by the handful of medications
prescribed for them when they are first diagnosed with heart disease,
but these medications have been shown in study after study to
make a real difference in how well these patients do. Dr. Gerber is a partner with Cardiology Associates of New Haven, 40 Temple Street, New Haven, CT. He is an attending physician at Yale-New Haven Hospital and an assistant clinical professor of medicine and cardiology at the Yale University School of Medicine. Dr. Gerber is also chairman of quality assurance at the Yale-New Haven Heart Center. |
