U.S. Army Captain Michael Kelvington, commander of the Battle company, 1-508 Parachute Infantry battalion, 4th Brigade Combat Team, 82nd Airborne Division, bows next to remains of Gulam Dostager, a member of Afghan Local Police who was killed in the blast of an Improvised Explosive Device (IED) during the joint Tor Janda (Black Flag in Pashtu) operation, in Zahri district of Kandahar province, southern Afghanistan May 25, 2012.  REUTERS/Shamil Zhumatov  (AFGHANISTAN - Tags: MILITARY CIVIL UNREST CONFLICT TPX IMAGES OF THE DAY)

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Members of the U.S. Navy Blue Angels fly over the World Trade Center in lower Manhattan as part of the 25th annual Fleet Week celebration in New York, May 23, 2012.  REUTERS/Eduardo Munoz (UNITED STATES - Tags: MILITARY ANNIVERSARY TPX IMAGES OF THE DAY)

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Glaxo's own meta-analysis also showed Avandia risk

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LONDON | Mon May 21, 2007 1:30pm EDT

LONDON (Reuters) - GlaxoSmithKline Plc said on Monday its own pooled, or meta, analysis of diabetes drug Avandia found a cardiovascular risk of about 30 percent but this was not borne out by long-term or observational studies.

"Long-term trials have not shown evidence of a risk at all and our observational studies have not shown any evidence that there is an excess of myocardial ischemic events in patients being treated with Avandia," Chief Medical Officer Ron Krall told reporters on Monday.

"The differences are probably related to the fact that the number of events in the meta-analysis are very small, so a few extra events makes a big difference in percentage terms."

He was responding to results of an independent meta-analysis published in the New England Journal of Medicine, which concluded Avandia increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent.

Krall said the company had presented its own meta-analysis to the U.S. Food and Drug Administration last August. Glaxo remains confident of the safety and overall benefits of Avandia, he added.

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