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Poor results for King Pharmaceuticals’ ramipril drug

King Pharmaceuticals' ramipril drug failed to meet its primary endpoint in a diabetes trial.

The drug was manufactured to prevent the development of type 2 diabetes in non-diabetic patients.

Patients taking ramipril showed no difference to the placebo group after three years.

However, King Pharmaceuticals said 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. This suggests that a longer follow-up period may have enabled detection of a significant ramipril treatment effect with respect to the composite primary endpoint. Blood sugar levels were significantly lower than after patients were administered ramipril. Also of significance, ramipril demonstrated a favorable effect on blood pressure compared to placebo.

“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.” said Jeffrey Probstfield, Professor of Medicine and Cardiology, at the University of Washington.

The trial was also designed to include subjects evaluated for the reduced risk of atherosclerosis with ramipril treatment. Results of the study of atherosclerosis are expected to be presented later this year.