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Abbot misses mark, Lilly/Takeda may help
Heart patients using Levosimendan no safer from death. Diabetes drug Actos reduces 2nd coronary.
November 16, 2005: 1:57 PM EST
By Aaron Smith CNN/Money staff writer
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DALLAS (CNN/Money) - Abbott's drug levosimendan failed to significantly reduce the death rate in patients with heart failure, according to researchers and the company, which announced study results Wednesday at the American Heart Association conference here.

Levosimendan, a drug from Abbott and Orion Pharma that helps the heart pump blood throughout the body, failed to meet its primary goal of reducing deaths by 25 percent after six months in the sickest heart failure patients, said Dr. Alexandre Mebazaa, lead investigator in the study.

Mebazaa, a professor of Anesthesia and Critical Care Medicine at the Hopital Lariboisiere in Paris, said that levosimendan, which is given intravenously to patients in hospitals, reduced death by 8 or 9 percent after 180 days, which is not considered statistically significant.

The benefits of levosimendan were stronger towards the beginning of treatment, said Mebazza, reducing death by 15 percent at about 30 days.

The purpose of the study was vital to the lives of millions of American and European heart patients, said Mebazaa, as some 27 percent of patients with heart failure die within six months.

"I know that in four patients I see before Christmas, at least one of them will die before Easter," said Mebazaa, who conducted the levosimendan study on more than 1,300 patients in nine countries.

Levosimendan, part of a class of drugs known as calcium sensitizers, helps the heart beat more forcefully and relaxes the blood vessels, making it easier to pump blood throughout the body. Levosimendan is currently not available in the United States but is marketed in 40 countries as Simdax.

Earlier Abbott studies

A separate levosimendan study announced on Monday found that hospitalized heart failure patients taking the drug showed a greater chance of recovery than those receiving standard care.

The study, funded by Abbott and Orion, focused on 600 heart patients and showed that risk of clinical improvement was 33 percent higher compared to standard care and the risk of clinical deterioration was 30 percent lower, according to lead investigator Dr. Milton Packer, professor and director of the Center for Biostatistics and Clinical Sciences at the University of Texas Southwestern Medical Center in Dallas.

Abbott, a Chicago-area drug maker with $19.7 billion in 2004 sales, also reported on Monday that its cholesterol drug Tricor failed to reach its primary goal in preventing fatal heart attacks.

Actos form Takeda, Lilly

Actos, a pill that reduces blood sugar in type 2 diabetics and helps them process insulin, was shown in a study to reduce additional heart attacks by 28 percent in patients who had already survived their first heart attack, said Dr. Erland Erdmann, a professor of medicine at the University of Koln in Germany, who played a lead role in the study.

Dr. Mehmood Khan, senior vice president of Takeda North America and head of the medical department, said the findings are particularly important as heart attacks are the leading cause of death in diabetics.

The study was funded by Takeda Pharmaceuticals N.A., the Chicago-area drug maker with a Japanese parent that produces Actos, and Eli Lilly & Co., the Indianapolis drug maker that markets Actos in the U.S.

Actos, also known as pioglitazone, has been on the market since 1999. The drug is FDA-approved to lower blood sugar and is also an insulin sensitizer, meaning that it helps the body process insulin. The drug treats patients with type 2, the most common type of diabetes, affecting more than 90 percent of the 18.2 million diabetics in the U.S.

Takeda, which is traded in Japan on the Nikkei, reported $6.3 billion in net sales for Fiscal Year 2004, which runs from April 2004 to March 2005. Lilly sales totaled $13.9 billion in 2004.

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