In a clinical trial, the blood pressure medicine Avapro didn’t perform better than other medicines used in treating a type of heart failure that mainly affects women and senior citizens.
Sold by Bristol-Myers Squibb Co. (BMY) and Sanofi-Aventis (SNY), Avapro was thought to reduce the rate of deaths and severe heart problems better than the drugs sufferers currently take, according to results published online by The New England Journal of Medicine.
The medicine is used to treat high blood pressure and kidney problems caused by type-2 diabetes. Avapro keeps blood vessels from narrowing, which decreases blood pressure and at the same time enhances blood flow.
Researchers at the University of Texas School of Public Health hoped the study, which enrolled more than 4,100 patients in 25 countries, would reveal that Avapro was efficient in treating low ejection fraction, a reduced ability to pump blood. "We were particularly disappointed because we still have large numbers of patients that still don't have a good treatment," stated Barry M. Massie, M.D., co-principal investigator of the study, professor of medicine at the University of California, San Francisco and chief of the cardiology division at the San Francisco Veterans Administration Medical Center.
In the study, the participants were randomly assigned to one of two groups: some were given irbesartan, an Angiotensin II Receptor Blocker (ARB) currently used to control high blood pressure, and others received usual care for preserved ejection fraction heart failure. To accurately evaluate the outcome, researchers followed the participants for a period of 4.5 years. The findings were presented on Tuesday 11 at the annual scientific sessions of the American Heart Association in New Orleans.
Researchers tested the hypertension drug in people with the type of heart failure in which the heart pumps well and is not enlarged, although it still causes typical symptoms like fluid retention, shortness of breath and swelling. They drew a comparison between the incidence of death due to any cause or hospitalization for a cardiovascular cause – for instance stroke, heart failure or heart attack.
According to Massie, almost 50 percent of the 5.3 million United States citizens with heart failure have preserved ejection fraction heart failure, and they tend to be women and elder.
Researchers were disappointed to see no significant difference between the composites rates of these events in the two groups. Irbesartan wasn’t able to cut the rate of the primary composite endpoint of all-cause mortality and hospitalization for a protocol-specified cardiovascular cause, compared to fake drugs (36 percent compared to 37 percent), said Peter E. Carson, M.D., co-principal investigator, associate professor of medicine at Georgetown University and chief of the coronary care unit of Washington Veterans Administration Medical Center in Washington D.C.
By the end of the 49.5 months of follow-up, 27 percent of patients taking irbesartan and 28 percent of those taking placebo were on spironolactone (Aldactone), and 38 percent who were given irbesartan and 39 percent assigned to the placebo group were on an ACE inhibitor. Researchers also said that 72 percent in both groups were on beta-blockers.
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