News Release

Pioglitazone HCI shown to lower blood pressure in hypertensive patients with type 2 diabetes

Peer-Reviewed Publication

Ketchum UK

Orlando FL, June 5, 2004 – Type 2 diabetes and hypertension are commonly associated conditions, both of which carry an increased risk of cardiovascular disease. Results of a large, open-label, multi-center, observational clinical trial show that treatment with the oral anti-diabetic agent pioglitazone HCl in people with type 2 diabetes has beneficial effects in reducing hypertension. The findings were presented today at the American Diabetes Association's 64th Annual Scientific Sessions.

In a study of 3,140 hypertensive patients with type 2 diabetes, all patients received open-label pioglitazone (30 mg/day) for 16 weeks. Hypertension was classified according to current National Institutes of Health guidelines (JNC VII): Stage I: 140-159/90-99 mmHg; Stage II: >160/>100 mmHg. Among patients with Stage I hypertension, pioglitazone elicited a mean decrease of 6.9/3.1 mmHg compared to baseline. In the patients with more severe, Stage II hypertension, pioglitazone was associated with a decrease of 18.7/8.3 mmHg.

"Although increasing clinical evidence suggests that drugs such as pioglitazone have blood pressure lowering effects, until now, those results had not been confirmed in large, unselected patient populations," noted lead investigator Thomas Konrad, M.D., Ass.Prof. Institute for Metabolic Research, Frankfurt, EU – RISC- Study Center. "The importance of treating hypertension in patients with type 2 diabetes is particularly crucial because of the high incidence of elevated blood pressure in people with diabetes. A major government study found that almost 80 percent of patients with diabetes also have hypertension, thereby compounding their cardiovascular disease risk. These blood pressure-lowering findings are remarkable, because they suggest that pioglitazone may be able to impact certain cardiovascular disease risk factors in patients with type 2 diabetes."

In patients with type 2 diabetes, management of risk factors beyond diabetes has been found to reduce the incidence of some major coronary events. For example, in a major study of intensive blood pressure control in patients with type 2 diabetes, stroke, was reduced by 44%.

Pioglitazone is an oral treatment for type 2 diabetes belonging to the thiazolidinedione (TZD) class of drugs. It is known as an "insulin sensitizer" because it directly targets insulin resistance, a condition where the body does not effectively use the insulin it produces.

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