Chicago, IL, March 31, 2008 New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS® (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.
The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death.
We are pleased with the results of the PERISCOPE, which further expands our cardiovascular data with ACTOS, said David P. Recker, M.D., senior vice president, Clinical Sciences and interim president at Takeda Global Research & Development. While not definitive, data from PERISCOPE combined with results from a previous study, looking at surrogate endpoints, have shown a consistent trend toward decreasing cardiovascular risk by reducing the atherosclerotic burden in people with type 2 diabetes.
PERISCOPE is the first clinical trial to examine the effects of an oral antidiabetic medication on the development of coronary atherosclerosis in patients with type 2 diabetes using IVUS technology. The trial conducted in 97 centers in the U.S., Canada and Latin America with 543 patients, used IVUS imaging of the coronary arteries. The analysis demonstrated a statistically significant difference in percent change in coronary artery atheroma volume in favor of ACTOS treatment compared to glimepiride treatment.
The data showed that patients treated with glimepiride, a sulfonylurea and commonly used diabetes medication, exhibited progression of coronary atherosclerosis. In contrast, the ACTOS arm showed no progression of coronary atherosclerosis over the 18-month period from the initial baseline measurement.
Cardiovascular safety data was collected by looking at macrovascular events and episodes of congestive heart failure (CHF). The number of episodes of a common cardiovascular endpoint of cardiovascular mortality, non-fatal MI, or non-fatal stroke was 6 (2.2%) in glimepiride patients and 5 (1.9%) in ACTOS-treated patients. The number of hospitalizations due to CHF was equivalent in both arms. In the ACTOS-treated group, eight patients experienced a bone fracture, none involving the hip or spine.
Atherosclerosis is a condition that leads to reduced or blocked blood flow, and is accelerated in patients with type 2 diabetes. Atherosclerosis-related cardiovascular disease is the leading cause of death and disability in people with type 2 diabetes. Published data shows that slowed progression and reductions in atheroma volume lessens the incidence of a second heart attack. IVUS measures the volume of plaque build-up in the coronary arteries, a marker of coronary atherosclerosis.
The data are consistent with the findings of the CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne) trial. Both PERISCOPE and CHICAGO support the findings of the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, which showed that ACTOS was not associated with an increased risk of heart attack, stroke or death.
|Contact: Amy Losak|
Takeda Pharmaceuticals North America