Preventing Diabetes – No DREAM Solution

The medical world is waking up from the “DREAM”? When a major international study – called the DREAM trial – reported last fall that the drug rosiglitazone appeared to prevent diabetes in 60 per cent of a group of people at high risk of developing the disease, it was hailed as a landmark in diabetes care. But a number of experts are now disputing the merits of putting lots of people on a costly drug to prevent some of them from developing the condition – especially when increasing exercise and improving diet lowers the risk of diabetes to the same degree.  An analysis in this week’s British Medical Journal suggests the results of DREAM should not be translated into reality.

"Clinical use of glitazones to prevent diabetes is, at present, impossible to justify," said Dr. Gordon Guyatt, One of the two principle investigators of the DREAM trial. 

Dr. Victor Montori, lead author of the analysis, states that,  "If I do nothing, 25 per cent of (high-risk) people will (eventually) need a drug. And instead of letting them find out who that 25 per cent is, I give it to 100 per cent of my patients," Montori, an endocrinologist and specialist in evidence-based medicine, said from Rochester, Minn., where he teaches at the Mayo Clinic College of Medicine. "No obvious benefit. Clear waste of societal resources. And a distraction from a clear message of lifestyle changes."

The findings from the Dream study were published in the Lancet last September, showed that people on rosiglitazone were substantially less likely to go on to develop diabetes while taking the drug.

Dr. Gerstein believes that this debate in the British Medical Journal is actually extremely positive. "And the more dramatic a discovery is,  the more debate it is going to engender and that’s good."  The DREAM study researchers had hoped that taking the medication for a period of time might actually stave off diabetes permanently, but that appears not to have been the case.

As yet unpublished results from a follow-up study which were presented at a medical conference in December showed that when people stopped taking rosiglitazone (sold as Avandia), they began to develop diabetes at the same rate as people in the study who had been given a placebo rather than a real drug. Those results dashed the dream that short-term use of the drug would do the trick.

"The only thing that it does is it prolongs the time before a doctor tells you ‘You have diabetes,"’ said Montori.

A group of U.S. experts has also turned thumbs down on rosiglitazone as a tool for diabetes prevention. The group reviewed evidence on it and two other drugs – metformin and acarbose – for a consensus article published this month in Diabetes Care.
Their recommendations for physicians with high-risk patients? Lifestyle modification should be the first line of approach. They said if any drug is considered for prevention, it should be metformin, which is off-patent, cheap and with a decades-long safety record. Evidence suggests it lowers the risk of developing diabetes by 30 per cent.

"In the consensus conference, we actually addressed these drugs individually and came to the conclusion that really, only metformin made sense and that specifically the thiozolidinediones do not," said Dr. David Nathan, the Harvard Medical School endocrinologist who chaired the consensus panel.  "Rosiglitazone has too much baggage with it, in a sense."

Like all drugs, rosiglitazone has side-effects in some people. Those who took the drug in the study gained an average of 2.2 kilograms and retained fluids. Other studies have shown use of the medication also raises the risk of heart failure, bone loss and bone fractures and macular edema, a buildup of fluid in the macula of the eye.

And Montori objects to the idea of using the drug in people who don’t have diabetes because it turns people into patients. Far better, he said, to urge those folks to kick up their exercise level and drop some weight.

"Pills beget blood tests to make sure the pills are not causing trouble, or to monitor the effect of this and more doctor visits to look over the results of those tests and see how you’re doing. All of a sudden, you become a patient. And up until that point . . . you’re just a healthy person at risk of a disease," he said.
BMJ April 2007      

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