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New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes

Tuesday, April 1, 2008 General News J E 4
CHICAGO, March 31 New data from a clinical trial usingintravascular ultrasound (IVUS) technology found that in patients living withtype 2 diabetes, ACTOS(R) (pioglitazone HCl) reduced the atheroscleroticburden in the coronary arteries compared to glimepiride, and preventedprogression compared to baseline. These data stem from the PERISCOPE(Pioglitazone Effect on Regression of Intravascular Sonographic CoronaryObstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57thAnnual 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, includingshort- and long-term trials, as well as prospective and observational studies,have shown no evidence that ACTOS is associated with an increased risk ofheart attack, stroke, or death.

"We are pleased with the results of the PERISCOPE, which further expandsour cardiovascular data with ACTOS," said David P. Recker, M.D., senior vicepresident, Clinical Sciences and interim president at Takeda Global Research &Development. "While not definitive, data from PERISCOPE combined with resultsfrom a previous study, looking at surrogate endpoints, have shown a consistenttrend toward decreasing cardiovascular risk by reducing the atheroscleroticburden in people with type 2 diabetes."

PERISCOPE is the first clinical trial to examine the effects of an oralantidiabetic medication on the development of coronary atherosclerosis inpatients with type 2 diabetes using IVUS technology. The trial conducted in 97centers in the U.S., Canada and Latin America with 543 patients, used IVUSimaging of the coronary arteries. The analysis demonstrated a statisticallysignificant difference in percent change in coronary artery atheroma volume infavor of ACTOS treatment compared to glimepiride treatment.

The data showed that patients treated with glimepiride, a sulfonylurea andcommonly used diabetes medication, exhibited progression of coronaryatherosclerosis. In contrast, the ACTOS arm showed no progression of coronaryatherosclerosis over the 18-month period from the initial baselinemeasurement.

Cardiovascular safety data was collected by looking at macrovascularevents and episodes of congestive heart failure (CHF). The number of episodesof 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%) inACTOS-treated patients. The number of hospitalizations due to CHF wasequivalent in both arms. In the ACTOS-treated group, eight patientsexperienced a bone fracture, none involving the hip or spine.

Atherosclerosis is a condition that leads to reduced or blocked bloodflow, and is accelerated in patients with type 2 diabetes. Atherosclerosis-related cardiovascular disease is the leading cause of death and disability inpeople with type 2 diabetes. Published data shows that slowed progression andreductions in atheroma volume lessens the incidence of a second heart attack.IVUS measures the volume of plaque build-up in the coronary arteries, a markerof coronary atherosclerosis.

The data are consistent with the findings of the CHICAGO (Carotid intima-media tHICkness in Atherosclerosis using pioGlitazOne) trial. Both PERISCOPEand CHICAGO support the findings of the PROactive (PROspective PioglitAzoneClinical Trial In MacroVascular Events) trial, which showed that ACTOS was notassociated with an increased risk of heart attack, stroke or death.

The CHICAGO Study

The CHICAGO trial was an 18-month, multicenter, randomized study thatenrolled 462 patients with type 2 diabetes, all from the Chicago area. Theprimary goal was to compare the effects of ACTOS versus glimepiride, asulfonylurea, on carotid intima-media thi


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