Takeda and Eli Lilly’s glucose-lowering drug Actos (pioglitazone HCl) has been found to significantly cut the combined risk of non-fatal heart attacks, strokes and deaths by an extra 16% when given in combination with standard drugs, such as statins, ACE inhibitors or beta-blockers, in patients with type 2 diabetes. In real terms, this means that, for every 48 patients treated with Actos over three years, one major cardiovascular event or death can be prevented, the firm noted.

“Seeing pioglitazone improve these cardiovascular outcomes (16% relative reduction) is an impressive result especially as these patients were already receiving standard treatments including the use of lipid-modifying drugs, anti-hypertensives, aspirin and other glucose-lowering agents,” commented Professor Ian Campbell, consultant physician at Victoria Hospital, Edinburgh, Scotland.

The primary endpoint of PROactive study, the results of which are published in The Lancet today, was to assess whether the drug had any effect on a combination of seven different major vascular events. Data showed that, although this was reduced by 10%, statistical significance was not reached by study end. But the strength of Actos’ efficacy in reducing life-threatening events, the trial’s secondary endpoint, has spurred Takeda into making preparations for a related label change.

Other encouraging findings from the trial revealed that in patients taking Actos versus placebo: HbA1c levels, which measure blood glucose control, were significantly cut 0.5%; lipid profiles were substantially improved through a 9% rise in high-density lipoprotein cholesterol and a 13% reduction in triglycerides; and systolic blood pressure was significantly lower.

This should provide Actos with an edge over its peers, including GlaxoSmithKline's Avandia (rosiglitazone) and Schering-Plough/Merck's forthcoming offering Pargluva (muraglitazar), which are all battling for a majority share of this highly-competitive market. 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." [[13/09/05a]]