WASHINGTON - The Food and Drug Administration approved a new treatment for congestive heart failure Thursday that when used in combination with older drugs can help certain patients live longer.
SmithKline Beecham's Coreg marks the first new approach to treating congestive heart failure in 14 years.
But the drug, known chemically as carvedilol, is for mild to moderate patients only, and must be used in addition to their standard medication, the FDA warned.
Congestive heart failure means the heart is so overstressed that it cannot properly pump blood. It kills 36,000 Americans annually and contributes to 250,000 other deaths. Patients typically receive a combination of digitalis, diuretics and powerful drugs called ACE inhibitors.
Coreg is a beta blocker, one of a family of drugs that slows the force and speed of heartbeats. Popular for treating high blood pressure, this type of drug had never before been cleared for heart failure.
In four trials of mild to moderate heart failure patients, adding Coreg to their standard medicine reduced the risk of hospitalization and death by 19 percent to 49 percent, SmithKline said.
However, the drug should not be used by patients with advanced heart failure, severe asthma, insulin-dependent diabetes or certain other heart conditions such as brachycardia.