GlaxoSmithKline representatives took center stage about an hour ago to defend Avandia (Rosiglitazone), the popular diabetes drug accused of causing increased incidence of cardiovascular problems in its patients.
At 8:45 a.m., a low rustle skirted through the room as reporters reopened notebooks and prepared to write.
After a lengthy presentation of data from several different studies of diabetes patients, the company's presentation was wrapped with this conclusion: That Rosiglitazone does not appear to cause any more heart risk than other oral anti-diabetic drugs on the market and that there are five studies (commissioned by GlaxoSmithKline) currently occuring. The presentation focused on risk of myocardial ischemia, myocardial infarction, stroke and cardiovascular mortality for patients on Rosiglitazone. Much of the data, according to GSK, showed no increased risk for diabetes patients on Rosiglitazone or was inconclusive.
GSK also offered suggestions before taking questions from the panel. Those suggestions are:
1. Include cardiovascular risk data in the drug's product label
2. Continue to analyze drug trials for cardiac events
3. Ask monitoring boards to continue work in tallying events
4. Continue ongoing, long-term trial
The FDA will give its presentations next.
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