An observational study based on a claims database of close to 30,000 patients published in Pharmacoepidemiology and Drug Safety showed that ACTOS (pioglitazone HCl) was associated with a 22 percent lower risk of hospitalization for acute myocardial infarction (AMI), commonly known as heart attack, in patients with type 2 diabetes when compared to rosiglitazone.

A total of 29 911 eligible patients were identified in the database; 14 807 in the ACTOS® and 15 104 in the rosiglitazone group. At baseline, the ACTOS® and rosiglitazone groups were well balanced, with the exception of statin and fibrate use, which was higher in the ACTOS® group, consistent with the higher prevalence of hyperlipidemia observed in this group. After adjusting for all known factors influencing the baseline risk of the patients (baseline covariates), the Hazard Ratio (HR) was 0.78 (95%CI: 0.63-0.96) for hospitalization for acute myocardial infarction in favour of Actos®, i.e. a 22% lower risk than for rosiglitazone.

These observations are consistent with the results seen in the landmark placebo-controlled PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) study. All studies conducted for the past 10 years, including those in both humans and animals, have shown no evidence that ACTOS® is associated with an increase in risk of heart attack or stroke. Since the introduction of ACTOS® in August 1999, almost 70 million prescriptions have been written, covering more than 8 million patients and 4.5 million patient years.

About ACTOS®

ACTOS® was originally approved by the European Medicines Agency for the treatment…