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Back To Vidyya FDA Approves Altace For Reducing Risk Of Heart Problems

Approval Is Based ask Heart Outcomes Prevention Evaluation Study (HOPE)

Based on the Heart Outcomes Prevention Evaluation study (HOPE), the FDA has approved a new use for the anti-hypertensive drug ramipril (Altace): reducing the risk of heart attacks, strokes and death in patients who are at increased risk for these problems.

The HOPE Study was a large multi-center randomized placebo- controlled study of more than 9000 patients in Canada, the United States, and South America, of whom 4600 received Altace.

Patients enrolled in the study were 55 years or older, and considered at high risk of developing a major cardiovascular event such as a heart attack because of a history of coronary artery disease, stroke or peripheral vascular disease. In addition, diabetic patients were eligible if they had at least one other cardiovascular risk factor among hypertension (high blood pressure), elevated total cholesterol, cigarette smoking, low HDL levels, or microalbuminuria (protein in the urine).

Patients did not need to be hypertensive to be enrolled and those who were hypertensive had their blood pressure controlled on other drugs. Patients with clinical heart failure or cardiac dysfunction were excluded. Thus, the HOPE study enrolled patients at an earlier stage of heart disease than have similar trials with other effective drugs.

Altace-treated patients in the HOPE study experienced a 22 percent reduction, compared with placebo, in the risk of myocardial infarction (heart attacks), stroke, or death from cardiovascular causes over five years of followup. This resulted in a significant reduction in the risk of death from any cause. Benefits of treatment were similar in subgroups distinguished on the basis of age, gender, underlying heart disease, diabetes, and the use of concomitant medicines.

Altace, an angiotensin converting enzyme (ACE) inhibitor, was approved in l991 for the treatment of hypertension. Altace is also indicated for reducing the risk of death and heart failure among patients who have had a myocardial infarction. Side effects of Altace include headaches, dizziness, fatigue, and a dry cough. All ACE inhibitors carry a warning that the drug should not be used in pregnant women.

Altace is manufactured by Aventis Pharmaceuticals, Kansas City, Mo. and distributed by Monarch Pharmaceuticals, Bristol, Tenn., a wholly owned subsidiary of King Pharmaceuticals, Inc.

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Editor: Susan K. Boyer, RN
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