FDA Approval of Ramipril for Cardiovascular Disease

FDA Approval of Ramipril for Cardiovascular Disease – Altace

Monica Preboth

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for ramipril (Altace) to reduce the risk of stroke, myocardial infarction and death from cardiovascular causes in patients 55 years and older with a history of coronary artery disease, stroke or peripheral vascular disease, or with diabetes and one other cardiovascular risk factor (e.g., elevated cholesterol levels, cigarette smoking).

The new indication is based on the results of the HOPE (Heart Outcomes Prevention Evaluation) study, which included 9,297 patients in 267 centers in 19 different countries. Participants were randomized to receive 10 mg of ramipril or placebo once daily for four years. Rates of reduction of cardiovascular events included 32 percent for stroke, 20 percent for myocardial infarction, 26 percent for cardiovascular death and 22 percent for all three endpoints combined. In the HOPE trial, a 10-mg dosage of ramipril decreased the incidence of death from any cause by 16 percent. The HOPE study also evaluated 3,577 patients with diabetes and found that cardiovascular events were reduced by 25 percent.

Adverse effects commonly associated with ramipril include headache, dizziness, fatigue and dry cough. Rare cases of angioedema have also been reported. Patients who are hypersensitive to ramipril or who have a history of angioedema related to previous treatment with an angiotensin-converting enzyme (ACE) inhibitor should not use ramipril. Pregnant women should avoid use of all ACE inhibitors, including ramipril, because they may cause injury or death to the developing fetus.

COPYRIGHT 2001 American Academy of Family Physicians

COPYRIGHT 2001 Gale Group