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11/16/1999

Ramipril Study Suggests Drug May Benefit Broad Group of Patients

Jane L. Miller

Inhibition of angiotensin-converting enzyme (ACE) may have broader applicability than has been appreciated to date. There is now evidence that the ACE inhibitor ramipril may reduce the risk of myocardial infarction, stroke, and death from cardiovascular causes in a diverse group of high-risk patients, including individuals not known to have heart failure.

The Heart Outcomes Prevention Evaluation study (HOPE) evaluated both ramipril and vitamin E in patients at high risk for cardiovascular events. The ramipril evaluation was halted early when a planned interim analysis revealed a significant treatment-related advantage. Results of the study will be published in the January 20, 2000, issue of the New England Journal of Medicine. The editors chose to release the ramipril results in November (see http://www.nejm.org/content/yusuf/1.asp) because of the potential implications for patient care. 

The HOPE researchers assigned 9297 patients to receive either ramipril 10 mg/day or placebo. The patients were at least 55 years of age and had a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes plus at least one other cardiovascular risk factor. Patients known to have a low ejection fraction or heart failure were excluded. Because of the trial size, ejection fraction was not measured in all patients. Among the study participants were 2480 women, 5128 patients age 65 or older, 8160 patients with cardiovascular disease, 4355 with hypertension, and 3578 with diabetes. 

Compared with placebo, ramipril was associated with lower rates of myocardial infarction (9.9% versus 12.2%; relative risk, 0.80; 95% confidence interval [CI], 0.71-0.91), stroke (3.4% versus 4.9%; relative risk, 0.69; 95% CI, 0.56-0.84), and death from cardiovascular causes (6.1% versus 8.1%; relative risk, 0.75; 95% CI, 0.64-0.87). A reduction in the risk of these three events combined was evident within one year's time and persisted into the fourth year of treatment. 

Secondary findings included ramipril-associated reductions in the risk of cardiac arrest, heart failure, worsening angina, revascularization procedures, complications related to diabetes, and new-onset diabetes. 

The researchers estimated that treating 1000 high-risk patients with ramipril for four years would prevent about 150 events in 70 patients. 

Subgroup analyses suggested that ramipril was beneficial in a number of patient subgroups defined a priori on the basis of age or risk factor.