Saturday 26 March 2011

Clinical trial of Pre-Diabetes treatment, ACT NOW

What IS pre-diabetes?

Pre-diabetes is defined as a condition where fasting blood sugar of the patient is between 100-125 mg/dl (according to the American diabetes association) or between 110-125 mg/dl (according to world health organization). If you have been diagnosed with pre-diabetes, click here.
  

Why is it important to identify patients with pre-diabetes?
  
For the simple reason, that a lot of pre-diabetics who do not achieve control on their sugars end up becoming full blown diabetics. They are at double risk for developing heart attack. what would happen if we treat someone who has pre-diabetes with medication? Does it help prevent diabetes and the dreaded complications?

In the most current issue of New England journal of medicine the medical group lead by Dr. DeFronzo and Dr. Tripathy attempt to answer just that question. Pioglitazone for Diabetes Prevention in Impaired Glucose Tolerance uses the drug pioglitazone (ACTOS) to treat about 600 patients with pre-diabetes. (ACT NOW trial)


Does treatment of pre-diabetes with Actos prevent full-blown diabetes?

Yes. At the end of 4 years, the time to develop diabetes was much lower in patients who received the drug. By 2.4 years, fifty patients in non-treatment group developed diabetes while fifteen in treatment group did so. In addition, at the end of 3 years the Hba1c was 2.5 points lower in treated group. ACTOS reduced the incidence of diabetes irrespective of age, sex or race. (equal opportunity treater?!)

This is result is not surprising; diabetes is defined biochemically by amount of sugar in your blood. By preventing the rise in sugar levels in blood, the diabetes is bound to be delayed.


Does treatment of pre-diabetes with Actos affect blood pressure or cholesterol?

There was no change in blood pressures between the two groups. HDL (good cholesterol) increased and triglycerides decreased in the treated groups.


So where does this study fit in?

Pre-diabetes is an important medical burden. The complications of diabetes have already have started in the pre-diabetic stage and thus intervention in this step will reduce them. The authors mention that similar trials with Metformin (GLUCOPHAGE) reduced the risk of conversion to diabetes by 31%, with thiazolidinediones (GLIPIZIDE, GLYBURIDE etc) down to 60% and with just life style modifications (good diet, weight loss, exercise) down to 58%. The ACTOS (pioglitazone) trial reduced it by 72%. 

Weight gain and edema (swelling and fluid retention) were the biggest side effects of the drug in the treatment group (205 patient versus 128 in non treated) and even lead to some patients dropping out. There is NO answer yet as to whether the increased weight and edema would lead to more heart disease.

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