A new analysis of the potential of Acomplia (rimonabant) as a treatment for prediabetics was sufficiently encouraging to lead researchers to conclude that a long-term study exploring the role of the new drug in preventing Type 2 diabetes is warranted.
Dr. Julio Rosenstock of the Dallas Diabetes Center in Texas presented a report on the analysis at the annual meeting of the European Association for the Study of Diabetes held Sept. 10th to 15th in Athens.
The analysis focused on a subgroup of 1,290
patients identified with prediabetes who participated in three large phase III clinical trials of Acomplia: RIO-Lipids, RIO-Europe and RIO-North America.
These are not patients who participated in the RIO-Diabetes trial, a phase III trial that showed Acomplia can help obese diabetics reduce their all-important HbA1c level -- a measure of blood sugar control.
For purposes of this latest analysis, prediabetes was defined by impaired fasting glucose greater than 100 but less than 125 mg/dL.
Rosenstock reported
that improvements among these prediabetics in terms of loss of weight, reduction in waist circumference, and improvement in multiple cardiometabolic
risk factors including HDL (good) cholesterol, and
triglyceride levels, and insulin resistance were consistent with the previously reported data from the large multicenter trials.
He also reported "a trend to reverse or retard the progression of impaired fasting glucose" among the prediabetic patients taking the higher 20 mg dose of rimonabant in the trials, though the numbers here were not statistically significant.
But the researchers concluded that "these data show that early intervention with rimonabant 20 mg in prediabetes improves the multiple metabolic risk factors associated with this condition.
"Further long-term, controlled, properly powered studies are warranted to explore the role of rimonabant in the prevention of Type 2 diabetes and cardiovascular disease in prediabetes," they added.
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