Abbott heart drug levosimendan fails to produce statistically significant reduction in mortality

By Angela McDaniels

Seattle, Nov. 16 - Abbott Laboratories said that results from a mortality trial conducted in patients with acute decompensated heart failure showed that Abbott's levosimendan resulted in statistically non-significant but consistently lower mortality compared with dobutamine through six months of follow up.

The study did not meet its primary endpoint of a statistically significant reduction in 180-day all-cause mortality, the company said.

"Although the study did not discern a difference in long-term outcome between levosimendan and dobutamine, earlier timepoints, closer to actual drug administration, appear to favor levosimendan," said lead investigator Alexandre Mebazaa of Lariboisiere Hospital in Paris, in a company new release.

The data was presented Wednesday at the American Heart Association 2005 annual meeting in Dallas.

The double-blind, randomized, controlled trial of intravenous therapy in 1,327 patients was designed to demonstrate a 25% reduction in mortality for levosimendan, compared with dobutamine, following a single intravenous infusion and was conducted in Austria, Finland, France, Germany, Israel, Latvia, Poland, Russia and the United Kingdom.

Levosimendan, known as Simdax outside the United States, is an investigational agent that uses calcium sensitization and potassium ATP channel opening. Both allow greater blood circulation from the heart to vital organs and tissues during an acute episode of heart failure, the company said.

Heart failure is a chronic condition resulting from weakened heart function that impairs the ability of the heart to pump blood throughout the body. In acute decompensated heart failure, patients have a sudden deterioration in heart function resulting in symptoms that require urgent medical treatment and often hospitalization, the company said.

First-year mortality rates are as much as 40% to 50%.

Abbott is based in Abbott Park, Ill., and develops pharmaceuticals and medical device products.

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