A study of 810,000 people, published online in British Medical Journal, found that those taking Avandia, a diabetes drug manufactured by GlaxoSmithKline, were 23 per cent more likely to suffer congestive heart failure, 16 per cent more likely to have a heart attack and 14 per cent more likely to die while on it, compared to a similar medication.
The study analysed the results of 16 separate studies in 810,000 patients, of which 429,000 were on Avandia (also known by its generic name rosiglitazone) and 381,000 were on Actos (also known as pioglitazone). The drugs both belong to a class that help control blood sugar levels in patients with Type 2 diabetes. The study found that Avandia could have led to an extra 431 deaths per 100,000 people on Avandia, an extra 170 heart attacks and an extra 649 cases of heart failure.
Reacting to the study findings, a GSK spokesperson said, “It is important to note that there are no head-to-head clinical studies with cardiovascular outcomes results between the two medicines. GSK believes that definitive conclusions about differences in cardiovascular data of the two medicines are hard to make in the absence of long-term trials directly comparing both medicines.”
“GSK stands behind the safety and efficacy of Avandia when used appropriately. Since 2007, results from six randomized clinical trials with data related to the cardiovascular safety of Avandia have been reported,” the GSK spokesman added. “Taken together, these trials showed that Avandia does not increase the overall risk of heart attack, stroke or death.”
In September 2010, European Medicines Agency (EMA) suspended the licence for Avandia, after 10 years on the market, saying the evidence of its harmful effects had tipped the balance against it being prescribed. The US health officials have also restricted the use of Avandia to patients with type 2 diabetes who cannot control their disease on other medications. [Source: Telegraph]