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Vol 275 No 7367 p330
17 September 2005

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Pioglitazone of benefit in high-risk diabetes patients

Treating patients at high risk of a second cardiac event with pioglitazone (Actos) leads to a 16 per cent reduction in the risk of stroke, myocardial infarction or death, according to results presented at this week's European Association for the Study of Diabetes conference in Athens.

Patients receiving pioglitazone suffered 301 incidences of stroke,myocardial infarction or death — the principal secondary endpoint of the study — compared with 358 incidences in the placebo group.

However, occurrence of the study’s primary endpoint — the time to occurrence of a composite of death, stroke, acute coronary syndrome, heart surgery and leg revascularisation or amputation — did not differ significantly between the two groups.

The PROactive (prospective pioglitazone clinical trial in macrovascular events) trial enrolled 5,238 patients aged 35 to 75 years with type 2 diabetes, who had HbA1c levels above 6.5 per cent and who had an established history of macrovascular disease. In addition to their existing therapy, the patients were randomised to receive either pioglitazone or placebo. Pioglitazone doses were increased after the first month from 15 to 30mg and after the second month to 45mg.

The study also found that pioglitazone led to decreases in HbA1c levels, reduced chances of patients progressing to permanent insulin use and a reduction in blood pressure.

Pioglitazone has just been approved by the Scottish Medicines Consortium for single drug treatment of type 2 diabetes.

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