KING, GSK PUBLISH DATA ON ALTACE, AVANDIA

King Pharmaceuticals and GlaxoSmithKline (GSK) have announced that that the results of the Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication (DREAM) study were presented at the European Association for the Study of Diabetes meeting in Copenhagen, Denmark, and published in the New England Journal of Medicine. The trial evaluated the likelihood of progression to Type 2 diabetes over a three-year median follow-up period among 5,269 participants with a condition known as pre-diabetes. Participants included in the study were randomized to GSK's Avandia (rosiglitazone maleate) (8 mg daily) or placebo and to King's Altace (ramipril) (15 mg daily) or placebo and were assessed every six months for three to five years to determine if rosiglitazone or ramipril can reduce the risk of developing Type 2 diabetes in individuals with pre-diabetes.

With respect to ramipril, the evaluated the primary composite endpoint of the development of Type 2 diabetes and death in non-diabetic patients at risk for developing diabetes due to impaired fasting glucose levels (IFG) and/or impaired glucose tolerance (IGT). Secondary endpoints included a return to normal glucose levels from IFG and/or IGT. While the incidence of the development of Type 2 diabetes in DREAM was lower overall among patients taking ramipril 15 mg compared with those taking placebo, the primary composite endpoint was not statistically different between ramipril and placebo by the end of the three-year follow-up period. The rates of development of diabetes began to diverge between the ramipril and placebo treatment groups beginning in the third year, with lower rates in the ramipril-treated group, suggesting that a longer follow-up period may have enabled detection of a significant ramipril treatment effect with respect to the composite primary endpoint.

Rosiglitazone reduced the risk of developing Type 2 diabetes by 62 percent relative to placebo among individuals at high risk of developing Type 2 diabetes. This 62 percent reduction was highly statistically significant and additive to standard counseling on healthy eating and exercise, which was provided to all participants in the trial. Over the three-year median follow-up period of the trial, 51 percent of the participants receiving rosiglitazone returned to normal blood sugar levels compared with 30 percent of participants receiving placebo. Thus, participants taking rosiglitazone were 70 percent more likely than those taking placebo to return to normal blood sugar levels. Participants with higher body mass index (BMI) were more likely than those with lower BMI to progress to Type 2 diabetes. However, the risk of developing diabetes did not increase with BMI in the group randomized to rosiglitazone. These findings suggest that rosiglitazone may reduce the risk of developing diabetes that is attributable to obesity.