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BRISTOL, Tenn. — King Pharmaceuticals, Inc. (NYSE:KG) today reported that the results of the Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication study (”DREAM”) were presented at the European Association for the Study of Diabetes (”EASD”) meeting in Copenhagen, Denmark, and published in The New England Journal of Medicine. With respect to ramipril, DREAM 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). Patients were randomized to either ramipril 15 mg or placebo for a median follow-up period of three years. Secondary endpoints evaluated included a return to normal glucose levels from IFG and/or IGT.

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While the incidence of the development of type 2 diabetes in DREAM was lower overall among patients taking ramipril 15 mg compared to those taking placebo (18.1% among patients taking ramipril 15 mg compared to 19.5% in 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. Importantly, 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.
Although the median follow-up period was only 3 years, DREAM reinforced the beneficial metabolic effects of ramipril that were previously reported in the landmark Heart Outcomes Prevention Evaluation Trial (”HOPE”), which evaluated ramipril in a different patient population over a longer period of 4.5 years. DREAM showed a significant normalization of IFG and IGT in the ramipril-treated group compared to placebo (42.5% versus 38.2%; P=0.001). Additionally, two-hour post load glucose levels were significantly lower by study end in the ramipril-treated patients compared to placebo (P=0.01).
Also of significance, ramipril demonstrated a favorable effect on blood pressure compared to placebo. The mean baseline systolic blood pressure (SBP) and diastolic blood pressure (DBP) for the DREAM population was 136 mmHg and 83 mmHg, respectively. Ramipril 15 mg decreased SBP 8.2 mmHg and DBP 5.4 mmHg, compared to 3.9 mmHg and 3.0 mmHg, respectively, for placebo (P less than 0.001 for both SBP and DBP).
“Given that patients with elevated glucose levels or impaired glucose tolerance are at least at a 50% greater risk of cardiovascular disease, the apparent metabolic benefit demonstrated in the ramipril-treated patients in DREAM is of interest and worthy of additional investigation,” said Jeffrey L. Probstfield, M.D., Professor of Medicine, Cardiology, at the University of Washington School of Medicine and the principal U.S. investigator for DREAM. “This finding suggests that a longer, or perhaps larger trial would be necessary to detect significant benefits of ramipril on the incidence of new onset diabetes and cardiovascular morbidity, if one exists, in this population of individuals.”
Previously, HOPE demonstrated that ramipril produced a significant reduction in cardiovascular events such as stroke, myocardial infarction, and cardiovascular death across a broad spectrum of high risk patients with cardiovascular disease or diabetes. Analysis of the HOPE data also indicated that patients with cardiovascular disease treated with ramipril were 34% less likely to report a new diagnosis of diabetes compared to those randomized to placebo. DREAM was initiated to further investigate these positive metabolic results in non-diabetic patients without high cardiovascular risk.
“The data presented today demonstrate that the metabolic benefits of ramipril appear to extend beyond patients with high cardiovascular risk like those included in HOPE. DREAM excluded participants with uncontrolled hypertension, cardiovascular disease and heart failure,” said Anne Peters, M.D., Professor of Clinical Medicine, Division of Endocrinology, University of Southern California Keck School of Medicine. “The benefit of normalizing glucose levels is important because IFG and IGT can be a precursor to diabetes.”
In the study, ramipril 15 mg was well tolerated, with a safety profile consistent with current labeling for ramipril. The composite cardiorenal and renal data will be analyzed and reported separately.
DREAM was also designed to include a subset of subjects evaluated for the reduced risk of atherosclerosis with ramipril treatment. Results of the Study of Atherosclerosis with Ramipril and Rosiglitazone (STARR study) are expected to be presented later this year. The presentation of persistent DREAM results eight weeks after drug withdrawal is also expected.