Calm Urged for Avandia Patients
No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed
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Calls for Independent Look at Avandia Risk continued...
Avandia gained FDA approval in 1999. That approval was based on the drug's ability to lower diabetes patients' blood-sugar levels.
"Why do we control blood sugar in diabetes? The reason is to control complications of diabetes," Nissen says. "Avandia has never been shown to control any diabetes complication. They have had eight years to show a health-outcome benefit. Yet they've shown no reduction in microvascular [eye, kidney, and extremity] complications and no reduction in cardiovascular [heart] outcomes."
Krall says such studies began very soon after Avandia approval.
"It takes studies of 10 years' duration or more to show clinical endpoints," he says. "It took 10 years to see clinical results in studies of [the older diabetes drugs] metformin and sulfonylura. It is not fair to expect those results yet for Avandia. What is clear is that if you do manage [blood sugar levels], you do see those endpoints in 10-plus years' time."
Alternatives to Avandia
Another drug in the same class as Avandia, Actos, has already been shown to lower -- not raise -- the risk of heart disease in diabetes patients.
"It may be hard to justify continuing to prescribe Avandia if there is an alternative, Actos, that does not have same risk profile," Meneghini says. "So in terms of new Avandia prescriptions, I don't think so. It is not so much a clinical decision as a liability decision. Because if a patient says, 'I want to come off the drug,' and his doctors says, 'No, continue taking it,' and the patient has a heart attack -- for whatever reason -- well, you can imagine what comes after that."
But Meneghini still says Avandia is helping some patients.
"In terms of patients currently on the drug, if they have had a good response in terms of blood sugar control, and no prior cardiovascular event, I don't see why they should not continue," he says. "In those with a history of heart trouble, maybe they should consider a change. Insulin therapy is one of the cleanest options we have at this point in time."