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Research again links Avandia with heart risks

GlaxoSmithKline's (GSK's) diabetes drug Avandia (rosiglitazone) is trouble again after more research warned of a link between the drug and heart failure.

GlaxoSmithKline's (GSK's) diabetes drug Avandia (rosiglitazone) is trouble again after more research warned of a link between the drug and heart failure.

Research published in the journal Diabetes Care found Avandia and Takeda's drug Actos (pioglitazone), could be responsible for an additional 5,000 cases of heart failure every year.

The analysis reviewed research studies and case reports involving more than 78,000 patients, and also looked at more than 200 cases of heart failure in patients who took Avandia or Actos.

The authors estimated that one additional patient with type 2 diabetes would develop heart failure for every 50 patients taking the drugs over a 26-month period.

According to the authors, fluid retention caused by the drugs may trigger heart failure in susceptible people.

"These drugs have been used by more than 3 million diabetic patients in the US alone, suggesting that several thousand could be harmed," said Dr Sonal Singh, lead author and an assistant professor in internal medicine at Wake Forest in the US.

Study results

Heart failure occurred equally at high and low doses. In fact, heart failure even occurred in some patients who were taking doses below those commonly prescribed. The medium time for the onset of heart failure was 24 weeks after beginning drug therapy.

The adverse reaction was not limited to the elderly - one-quarter of cases occurred in people younger than 60. Heart failure occurred equally among men and women.

The current warning label on Avandia says there is a risk of increased heart failure in patients with existing heart conditions, and also if it is combined with insulin, but according to the researchers, the new analysis shows that the risk is not merely confined to patients with existing conditions, or those on insulin.

"Our findings support current efforts by the FDA to add a black box warning to the labeling for those agents," said co-investigator Dr Curt Furberg, another research author, from Wake Forest.

Dr Yoon Loke, from the University of East Anglia and one of the research authors, said while the risk was small, the fact that 500,000 people take these drugs meant that could mean an extra 5,000 cases of heart failure.

GSK continues to defend Avandia and points out that "whilst continued patient safety is paramount, we must also remember that Type II diabetes can have devastating consequences including stroke, blindness, amputation and kidney failure. Avandia therefore has an important role to play as one of the medicines, doctors can use to treat the 2 million patients currently diagnosed with type 2 diabetes in the UK," said, Dr Alastair Benbow, European medical director at GSK.

The company continues: "It is important for physicians to use Avandia in appropriate patients in line with the European SPC, which states that Avandia should not be used in patients with congestive heart failure (CHF).  GSK is confident in the overall safety profile of Avandia when used appropriately."

Matt Hunt, science information manager at charity Diabetes UK said: "Drug risks are evaluated frequently and neither the Medicines Healthcare Regulatory Agency (MHRA) or the National Institute for Health and Clinical Excellence (NICE) are calling for the withdrawal of glitazones. Obviously new evidence should be considered by the MHRA on an ongoing basis."

Both the European Medicines Agency (EMEA) and the MHRA are re-evaluating the drugs' benefits in light of possible links with heart failure. The US Food and Drug Administration (FDA) is due to meet on Monday 30 June to discuss the safety of Avandia. 

27th July 2007

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