New study backs diabetes drug Avandia, GSK says

Updated June 6, 2009

New study backs diabetes drug Avandia, GSK says

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Research Triangle Park, N.C. —

A GlaxoSmithKline (NYSE: GSK) study rebuts claims that its much criticized diabetes drug Avandia is linked to hear attacks..

However, some cardiologists remain unconvinced and say GSK's research is flawed, the news service report, according to Dow Jones News Service.

"I'll repeat it and I know it's difficult to believe, but Record has delivered what it set out to do," GSK's Murray Stewart told Dow Jones in an interview, referring to the study by name.

The GSK study and others are being unveiled at the American Diabetes Association conference in New Orleans.

“Record provides a robust assessment of rosiglitazone’s cardiovascular safety and achieving the study’s primary endpoint leads us to conclude that rosiglitazone carries no increased risk of overall cardiovascular death or hospitalization compared to the most commonly used diabetes medicines, metformin and sulfonylurea, which have been used for decades,” said Dr. Philip D. Home, chairman of the Record Steering Committee and a professor at Newcastle University in the United Kingdom, according to a statement issued by GSK.

“Millions of patients with diabetes do not achieve good blood sugar control, even with combination therapy, making a wide range of therapeutic options critical for the management of this growing and deadly disease," he added.

More news is expected from the meeting.

“GlaxoSmithKline has a lot on the line,” Dow Jones News Service reported Friday. “Four major studies, including a controversial study called RECORD, involving Avandia are being released. The ADA and a leading European diabetes association unanimously recommended doctors last year stop giving patients Avandia after studies showed it put patients at higher risk of heart attacks.”

Meanwhile, GSK received some other good news Friday when the World Health organization endorsed the company’s vaccine against diarrhea.

“The WHO said that Glaxo's Rotarix and rival drug RotaTeq, made by United States giant Merck, should be included in all national immunization programs to protect against rotavirus,” the London Evening Standard reported.

“Both vaccines have been available in Europe and the US for the past three years, but had not previously been tested for use in the developing world, where rotavirus causes the most deaths,” the paper added.

In a statement, GSK hailed the WHO decision.

“Today’s approval is the culmination of a long-standing commitment at GSK to deliver a rotavirus vaccine for the world,” said Jean Stéphenne, chief executive officer of GSK Biologicals. “Five years ago, GSK pursued a different regulatory strategy to speed the availability of Rotarix™ by introducing the vaccine in developing countries first, where the medical needs and mortality rates are highest. In Latin America, we carried out some of the largest clinical trials for a vaccine in history and continued clinical studies of the vaccine in a range of different settings in both rich and poor countries.”

GSK, one of the world's largest pharmaceutical companies, maintains its U.S. headquarters in RTP. it employs some 5,000 people in the Triangle area.