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Mixed welcome for GSK’s diabetes DREAM

The largest ever trial into diabetes prevention has reportedly shown that Avandia (rosiglitazone) can prevent the onset of Type 2 diabetes in a large proportion of high-risk patients.

The largest ever trial into diabetes prevention has reportedly shown that Avandia (rosiglitazone) can prevent the onset of Type 2 diabetes in a large proportion of high-risk patients.

The drug also restored normal blood glucose concentrations in about half of treated patients, researchers reported.

The findings, gathered from the DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial, were presented at the European Association for the Study of Diabetes meeting and simultaneously published online by The Lancet.

Hertzel Gerstein, of the Population Health Research Institute at McMaster University, Canada, who led the study, said the research team was “quite pleased” with the results, but warned: “No one drug is going to stop an epidemic of this size. The only way to do that is to re-engineer society so people change their diets and increase physical activity.”

He added that the drug could offer an “additional option” to lifestyle therapies.

The international, multicenter trial took place in 191 sites in 21 countries over three years. 5,269 adults were enrolled. To be eligible, patients needed to have impaired fasting glucose, impaired glucose tolerance, or both, but no history of diabetes, cardiovascular disease, or intolerance to either angiotensin-converting enzyme inhibitors or thiazolidinediones.

Volunteers were randomised to either placebo or 8 mg/day of Avandia and followed for three years. The primary outcome of the study was a composite of incident diabetes or death.
The study found that 306 of the 2,365 individuals given Avandia (11.6%) and 686 of the 2,634 given placebo (26.0%) developed the composite primary outcome. Slightly more than half of those in the Avandia group (1,330 or 50.5%) and 798 (30.3%) in the placebo group became normoglycemic.

The authors said: “The results of this study suggest that the addition of rosiglitazone to basic lifestyle recommendations substantially reduces the risk of developing diabetes by about two thirds, offering a novel preventive approach.”

Despite the findings, prominent physicians have expressed doubt that Avandia will fully capture the market for patients with pre-diabetes, citing concerns over increased risk of heart problems. During the trial, volunteers treated with Avandia showed an increased rate of cardiovascular events. Although the values were not statistically significant, an accompanying editorial in The Lancet, where the results were published, identified these concerns as being likely to deter government funding and insurance companies.

Jaakko Tuomilehto of the University of Helsinki and Nicholas Wareham of the MRC Epidemiology Unit in Cambridge, UK, wrote: “Unfortunately, the greater benefits in higher risk individuals would have to be balanced against the likely increased risk of heart failure.”

Dr Steven Nissan, chairman of cardiology at the Cleveland Clinic, also voiced his concern: “The strong trend towards increased cardiovascular events is very troubling,” he said.

However, Paul Zimmet, director of Melbourne’s International Diabetes Institute, said Avandia offered an extra option for physicians.

“It will take five to 10 years to change the paradigm of how we think of diabetes, but I think there will be many more people treated at an earlier stage than we do now,” he said.

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