Low-dose combination therapy may prevent diabetes--study

The study exhibited very few side effects. The drug combination appeared to counteract the weight gain, congestive heart failure and diarrhea that is common with Avandia therapy alone.

A new study suggests that a low-dose combination therapy using GlaxoSmithKline (GSK) Avandia and anti-diabetic treatment metformin may help prevent progression to type 2 diabetes by two-thirds in people at risk of the ailment.

According to experts, Avandia, also known as rosiglitazone and metformin both lower the development of diabetes in patients with impaired glucose tolerance (IGT).

However, both the drugs work differently. While, Avandia is known to increase insulin sensitivity, metformin reduces liver glucose production.

Lead author of the study, Dr. Bernard Zinman, director of the Leadership Sinai Centre for Diabetes at Mount Sinai Hospital and the University of Toronto stated, "Diabetes is a complex metabolic disorder, and it's unlikely that there will ever be one magic bullet that treats or prevents diabetes.

“So, more like treatments for HIV/AIDS or cancer that use a drug cocktail, we attempted to look at two drugs that have been known to have beneficial effects in diabetes.

"We were pleasantly surprised to find that using half of the maximum dose was extremely effective for preventing type 2diabetes.”

The study found that only 14 percent in the drug-combo group developed type 2 diabetes compared with 39 percent in the placebo group. In addition, the mixture therapy reduced the relative risk of diabetes by 66 percent and the absolute risk by 26 percent.

Safety and efficacy of combination therapy assessed
In order to determine the safety and efficacy of a low dose combination therapy in diabetes prevention, the researchers enrolled 207 patients with IGT.

Of these, 103 patients were randomly administered a blend of rosiglitazone (2 mg) and metformin (500 mg) twice daily and 104 assigned to placebo for a period of around 4 years.

Observations by researchers
The researchers noted that medication compliance was 78 percent in the combination therapy and 81 percent in the placebo group.

It was also observed that in the drug-combo group only 14 percent developed type 2 diabetes compared with 39 percent in the placebo group.

In addition, the mixture therapy reduced the relative risk of diabetes by 66 percent and the absolute risk by 26 percent.

Zinman declared, "The notion here is to use low doses, in combination, because diabetes and prediabetes are complex diseases, and you need to target various aspects of the pathophysiology, and that's exactly what we've done.

"We used a combination of half-dose metformin and half-dose rosiglitazone to improve insulin sensitivity, decrease hepatic glucose production, and have what we hope would be a robust effect on preventing diabetes. And we achieved that."

No serious side effects
Moreover, the study exhibited very few side effects. The drug combination appeared to counteract the weight gain, congestive heart failure and diarrhea that is common with Avandia therapy alone.

Bernard Zinman stated, "Remarkably, the effect of the combination was remarkably robust with over 60% decrease in risk of diabetes.

“And the well-known side effects did not appear. There was no weight gain, no fluid retention, fractures were equal in both the treatment and placebo groups, and while there was some diarrhea, it was low intensity."

The study has been published in the 'Lancet.'

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