(ramipril, Wyeth-Ayerst, King Pharmaceuticals)
An angiotensin-converting enzyme inhibitor for reducing the risk of MI, stroke, and death from cardiovascular causes in people aged 55 and over who are at high risk of a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes accompanied by at least one other cardiovascular risk factor. This is the first ACE inhibitor approved for this indication.
* Recommended Dosage: 10 mg daily.
* Special Considerations: Can be used with other necessary treatments, such as antihypertensive or antiplatelet therapy. In the multinational trial that led to approval of this indication, the only major common side effect was a 5% rate of cough in Altace-treated patients.
* Comments: Approval was based on the Heart Outcomes Prevention Evaluation (HOPE) multinational study, which compared 10 mg of Altace a day to placebo in 9,297 men and women at high risk of cardiovascular events due to evidence of vascular disease or diabetes and one other cardiovascular risk factor. People with heart failure or left ventricular dysfunction were excluded; those who were hypertensive were controlled on medications.
Over a mean 4.5 years of follow-up, 14% of those on Altace reached the combined end point of MI, stroke, or death from cardiovascular causes vs. nearly 18% of those taking placebo. This represented a highly significant 22% risk reduction, and the study was stopped. Significant reductions in risk were seen for each individual end point as well (N. Engl. J. Med. 342:145-53, 2000).
Presenting these data for the manufacturer at a Food and Drug Administration hearing earlier this year, Dr. Salim Yusuf, chair of the study, said that benefits were "consistently observed in a very broad range of high-risk patients and in addition to other effective therapies," which included aspirin, [beta]-blockers, and lipid-lowering drugs. "If we treated 1,000 people [with ramipril] for 4 years, we could prevent 18 deaths, 16 myocardial infarctions, and 9 strokes," for a total of 43 events, Dr. Yusuf, director of the cardiology division at McMaster University, Hamilton, Ont., said at the hearing.
Most of the HOPE subjects were white; 141 were African American, 533 were Hispanic, and 155 were Asian. The HOPE study was funded by King Pharmaceuticals, in addition to other pharmaceutical companies and the Medical Research Council of Canada.
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