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More good news for Actosí safety profile

There is more good news for Japan-headquartered Takeda's diabetes drug Actos, with new research showing a 38 per cent lower risk of heart attack

There has been more good news for Takeda's diabetes drug Actos (piogliazone), with new research showing a 38 per cent lower risk of heart attack. 

Data presented at the 43rd Annual Meeting of the European Association for the Study of Diabetes (EASD) reinforced the view that the pioglitazone molecule has different effects from those seen in the other thiazolidinedione, rosiglitazone, due to differences in molecular structure.

The research was a retrospective analysis of case records from a large managed care database of diabetes patients and showed the adjusted relative risk of stroke for the pioglitazone group was 20 per cent lower than the group not receiving pioglitazone.

Likewise, the risk of heart attack over the study period was 38 percent lower in patients receiving pioglitazone than in those taking an anti-diabetes drug regimen that did not include pioglitazone. 

John Betteridge, professor of endocrinology and metabolism at University College, London, said: "The results of this analysis are very welcome and support the findings from the PROactive study of pioglitazone for secondary prevention of vascular events which showed a reduction in stroke and heart attack in this high risk population."

GLAI study
Another study, GLAI, was also presented at EASD, further proving the cardioprotective strength of pioglitazone.

A new analysis of data from the first three months of this six-month head-to-head study of pioglitazone and rosiglitazone, in which the endpoint was the change in serum lipids, demonstrated that initial treatment with a starting dose of pioglitazone (30 mg) was more effective than a starting dose of rosiglitazone (4 mg) in improving blood glucose (HbA1c) levels and lipid levels. 

Researchers also found that in addition to lowering HbA1c significantly more than rosiglitazone, pioglitazone also significantly decreased triglyceride levels and non-HDL cholesterol (a predictor of cardiovascular death), and markedly improved HDL-C levels ('good' cholesterol) versus rosiglitazone.

"A likely explanation for the different effects on heart attack and strokes between the two drugs could be the favourable effect of pioglitazone in increasing HDL cholesterol without adverse effects on LDL," explained Betteridge.

Actos is now the only treatment not to have a black box warning for cardiovascular conditions, and looks set to become the market leader over GlaxoSmithKline's troubled diabetes drug Avandia.

Actos' patent expires in 2011 and Takeda recently announced a potential successor, SYR-472.

The drug is in the second of three stages of patient studies needed for regulatory review, according to Kiyoshi Kitazawa, head of Takeda's product-planning unit. The drug's development status was revealed in a conference call with analysts and reporters on 1 August. Takeda also said that it was developing SYR-322 as another possible Actos replacement.

20th September 2007

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