Takeda and partner Eli Lilly have scored a massive boost to the profile of their diabetes drug Actos (pioglitazone) after data from the landmark PROactive trial demonstrated a significant 16% reduction in the risk of death, stroke or heart attack amongst type-2 diabetics who were already receiving best standard of care (including blood pressure lowering agents, lipid-modifiers and antidiabetic drugs). The results were unveiled with great fanfare at the 41st Annual Meeting of the European Association for the Study of Diabetes.

Although the study did not reach statistical significance in the primary measure of seven different macrovascular events, in the secondary endpoint of reducing the most serious events - death, stroke and heart attack – it notched up a win. In these people, the study showed that Actos could prevent 21 deaths, strokes or heart attacks per 1,000 patients over a three-year period.

The PROactive trial involved over 5,000 patients who had been diagnosed with type 2 diabetes for almost a decade and all were at increased risk of macrovascular disease. Participants were followed up for at least 30 months, and results showed not only a significant improvement in blood glucose control, but also a significant improvement in blood lipid levels – with a 9% rise in the good HDL cholesterol over best available care and a 13% reduction in triglycerides. However, there was a 2% increase in the bad LDL-c compared with the gold-standard care, but the companies were quick to note that the overall LDL:HDL ratio was benefited.

And in such a highly competitive sector, the marketing machine is already grinding away at Lilly and Takeda as they look to gain ground on GlaxoSmithKline’s Avandia (rosiglitazone) and Schering-Plough/Merck’s forthcoming offering Pargluva (muraglitazar) [[12/09/05b]]. Professor John Betteridge, Professor of Endocrinology and Metabolism at University College, London, and the UK Lead Investigator for PROactive said: “Notably, these benefits were over and above those achieved with optimised standard care and, as a result, I would expect Actos to be considered for many high-risk people with type 2 diabetes.”