Study participants were randomly assigned to receive either 45 milligrams of pioglitazone daily or a placebo. Each participant had fasting blood sugar tests done quarterly, and glucose tolerance testing done annually to check for diabetes. The average follow-up time was 2.4 years.
The average rate that type 2 diabetes developed in the study participants was 2.1 percent for the pioglitazone group and 7.6 percent in the placebo group. And, nearly half of those on pioglitazone returned to normal blood sugar levels, while just 28 percent of those in the placebo group did.
In addition, people in the pioglitazone group averaged lower blood pressure, and had reduced inta-media carotid thickening (a measure of plaque build-up in the carotid artery). Levels of "good" HDL cholesterol also increased in the pioglitazone group.
The news wasn't all good, however. The people in the pioglitazone group experienced more adverse events (151 vs. 121) and gained an average of about nine pounds, and experienced more fluid retention (edema), than people taking the placebo. (The U.S. Food and Drug Administration has warned that, as with other thiazolidinediones, pioglitazone can cause fluid retention, potentially leading to or exacerbating heart failure.)
However, DeFronzo said that the weight gain was somewhat paradoxical because the drug causes fat deposits in superficial tissues, and moves fat out of the liver, heart and abdomen, where it's more detrimental to your health.
Fonseca said the results from this study look excellent, but added, "One has to consider the lack of knowledge of long-term safety in a population that's already at risk of disease."
"People with prediabetes should seriously think about healthy lifestyle changes first, and if you can't achieve a healthy lifestyle, you should t
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