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News in Brief

The newly approved oral glucose-lowering drug Actos (pioglitazone) significantly reduces the risk of heart attack and stroke in at-risk patients with Type 2 diabetes, according to data from the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) presented at the 41st meeting of the European Association for the Study of Diabetes (10–15 September, 2005, Athens, Greece). The randomized, double-blind, placebo-controlled trial involved 5238 patients with Type 2 diabetes and macrovascular disease across 19 countries in Europe. Patients were randomly assigned to receive either pioglitazone or placebo on top of their standard treatment, which included antihypertensives (e.g., angiotensin enzymeconverting inhibitors and β-blockers), glucose-lowering agents (e.g., metformin, sulphonylureas and insulin), antiplatelet drugs (e.g., aspirin) and lipid-modifying medicines (e.g., statins and fibrates). In order to assess the effects of pioglitazone on mortality and morbidity associated with cardiovascular disease progression in this study population, the trial focussed on the two combination end points of macrovascular events (primary end point) and lifethreatening events (principal secondary end point), including nonfatal heart attack, stroke and death from any cause. The primary end point was reduced by 10%, but had not reached statistical significance by the end of the study period (p = 0.095). In the pioglitazone group, the principal secondary end point was significantly reduced by 16% (p = 0.027). “The PROactive study is the first in the world to prospectively show that a specific oral glucose-lowering medication, namely pioglitazone, can significantly improve cardiovascular outcomes by helping to delay or reduce heart attacks, stroke and death in high-risk patients,” said John Dormandy, Professor of Vascular Sciences at St. George’s Hospital (London, UK), and Chairman of the PROactive Study Steering Committee. “This groundbreaking study gives new hope to people with Type 2 diabetes who, despite their attempts to control blood glucose and take medications, fear these life-threatening events.” In addition, the PROactive study demonstrated that compared with placebo, pioglitazone significantly reduced HbA1c levels, improved lipid profiles by increasing high-density lipoprotein cholesterol levels and reducing triglycerides, decreased systolic blood pressure and reduced the number of patients requiring the permanent addition of insulin to their treatment. With regards to safety, adverse events reported in this high-risk study group were consistent with the known safety profile of Actos.