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Bristol, Sanofi’s Avapro Doesn’t Benefit Heart Rhythm Patients

Bristol-Myers Squibb Co. and Sanofi-Aventis SA’s hypertension drug Avapro failed to prevent complications such as heart attacks or lower death rates when given to people with erratic heart rhythms in a trial.

The results, published in the New England Journal of Medicine, show reducing blood pressure levels in people with atrial fibrillation doesn’t lead to fewer cardiovascular complications. Heart attacks, strokes and related deaths occurred in 5.4 percent of patients given Avapro or placebo in addition to standard care, the company-funded study found.

High blood pressure is the most-common risk factor for atrial fibrillation. Researchers hypothesized that they could lower the risk by giving a drug like Avapro to bolster the electrical and mechanical properties of the heart.

“There had been a lot of hope that these medicines might have specific benefits in atrial fibrillation,” said researcher Jeff Healey, a cardiologist at the Population Health Research Institute at McMaster University in Hamilton, Ontario. “There was no overall benefit. For that reason we don’t recommend routine treatment with this for atrial fibrillation.”

The study did yield some intriguing findings, he said in a telephone interview. Analysis showed Avapro reduced hospitalization rates for heart failure and some types of stroke. Future studies of patients with erratic heart rates should closely monitor heart failures, he said.

“Given that these are common outcomes, we are encouraged that further blood pressure lowering may be helpful in patients with atrial fibrillation,” he said.

The study included 9,016 patients with atrial fibrillation, where the upper chambers of the heart quiver rather than contract. The condition enables blood to pool and form into clots, which can cause strokes and other complications. More than 2.2 million Americans suffer from it and 11,000 die every year, according to the American Heart Association.

Bristol-Myers, based in New York, posted sales of $1.2 billion in 2010 for Avapro and a related drug, Avalide, which combines the active ingredient of Avapro with a generic hypertension drug called hydrochlorothiazide. Paris-based Sanofi generated 1.3 billion euros ($1.8 billion) from sales of the drug, which it markets as Aprovel.

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