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Takeda reacts to JAMA meta-analysis of Actos

Takeda reacts to a review of Actos' cardiovascular safety data published in the Journal of the American Medical Association

Japanese pharmaceutical company Takeda has reacted to a review of Actos (pioglitazone) cardiovascular safety data published in the Journal of the American Medical Association (JAMA).

Dr Mehmood Khan, president of Takeda Global Research & Development (TGRD), said in a statement: "The breadth and depth of data have all shown no evidence that Actos is associated with an increased risk of heart attack or stroke. Critical in this body of data is the PROactive study, since the only scientific way to determine a medication's safety is a prospective, long-term trial."

"Although drugs may be in the same class, they also can have different clinical effects due to differences in molecular structure. Actos is an effective and appropriate treatment option for people with type 2 diabetes. Since its approval in August 1999, almost 70 million prescriptions have been written, covering more than eight million patients and 4.5 million patient years," concluded Dr Khan.

PROactive saves the day
The critical data was taken from the PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) trial led by Dr A Michael Lincoff and colleagues at the Cleveland Clinic in the US described patients with type 2 diabetes at high risk for cardiovascular events.

The researchers concluded that Actos was associated with a significantly lower risk of heart attack, stroke or death among a diverse population of patients, compared with diabetes versus control therapy.

Meta-analyses collect data across a number of studies, and while not as rigorous as longitudinal study data, it can offer insight into aspects of a compound or product that may not be readily available from individual studies.

The JAMA meta-analysis has added important information to the body of evidence regarding Actos and macro-vascular ischemic events and supports the consistency of data from both observational and prospective studies.

Results from PROactive have been added to the Actos label and state that data show no increase in mortality or total macro-vascular events with the drug. Thus, Actos is currently the only thiazolidinedione (TZD) with safety data from a cardiovascular outcomes trial included in its label.

Professionals welcome data
Anthony Barnett, professor of medicine at the University of Birmingham and clinical director of diabetes and endocrinology for the Heart of England NHS Foundation Trust, told PMLive: "The debate over the safety of TZDs is one of the most topical in diabetes today. Since Nissan's paper in the New England Journal of Medicine, there has been a view among many opinion leaders, particularly in the US, that there must be something in this data despite the limitations of this type of analysis. It has even been suggested that GSK's own data provide a signal for a cardiovascular safety problem. Some experts have extrapolated this to cast doubt on the whole class."

Barnett added: "The JAMA papers might help to put these issues into perspective. The meta-analysis with rosiglitazone again suggests increased risk of myocardial infarction (although interestingly not for cardiovascular death); the meta-analysis with pioglitazone appears to show the opposite, with a reduction in relative risk of cardiovascular endpoints."

"Is this due to basic differences in the lipid effects between the two drugs (already well described), or are there profound methodological problems with this type of analysis? At the moment, the weight of evidence seems to suggest that these differences may be 'true bill', and it is now incumbent on GSK to address these issues head on. I will be interested to see what they say at what clearly is a difficult time for them," concluded Barnett.

30th September 2008


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