Blood-Pressure Drug Approved to Prevent Stroke, Heart Attack
Oct. 6, 2000 (Washington) -- Older people who are at risk of suffering a heart attack or stroke have a new reason to take heart. The FDA on Friday approved a new drug for the prevention of a stroke, heart attack, or death from other cardiovascular causes in high-risk people 55 years and older.
Called Altace (ramipril), the medication belongs to the class of drugs called ACE inhibitors. It was first approved in 1991 to treat high blood pressure, a major risk factor for heart disease. As an inhibitor of an enzyme believed to constrict blood vessels, it later also was approved to prevent strokes in people who had already suffered heart attacks.
The new use is based on evidence from a study of more than 9,000 patients in Canada, the U.S., and South America. The study originally was slated to take five years, but an independent monitoring board halted it a year early because of clear evidence about the drug's benefits, says Jefferson Gregory, RPh, JD, president of King Pharmaceuticals, the maker of Altace.
In that study, the patients treated with Altace saw their risk of dying from either a stroke, heart attack, or other cardiovascular disease, such as coronary artery disease, cut by more than a fifth, he tells WebMD. That breaks down to a reduction in the risk of having a stroke by about a third, in the risk of having a heart attack by one-fifth, and in the risk of dying from other heart conditions by more than one-fourth, Gregory says.
The study showed that more can be done to help people at risk of having a heart attack or stroke, even if they already are being treated for other risk factors, such as high cholesterol levels, Gregory says. In fact, the results demonstrated a 16% reduction in all causes of deaths, showing that this benefit can be seen statistically even when you consider other, unrelated causes of death, such as shootings and car accidents, he tells WebMD.
The benefits were seen in all at-risk groups, including those who had diabetes, underlying heart disease, or were using medications such as cholesterol lowering drugs or aspirin -- two common drugs given to people at risk of heart attack, the FDA says. "This resulted in a significant reduction in the risk of death from any cause," the agency said in a prepared statement.
Altace also could someday prove to be an important treatment option for people with diabetes, Gregory tells WebMD. In the study, there appeared to be about a 30% reduction in the formation of adult diabetes, he explains. The study was not designed to confirm this benefit, but the company, along with other drugmakers, now intends to investigate whether Altace can prevent the onset of adult diabetes, he says.