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Glaxo's own meta-analysis also showed Avandia risk

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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