GlaxoSmithKline Plc’s Avandia (rosiglitazone), a drug approved to treat type 2 diabetes, increased the chances of having a heart attack by 42 per cent, while Takeda Pharmaceutical Co.’s competing drug Actos lowered the risk of heart attack, strokes and death by 18 per cent (while increasing the rate of heart failure), according to research. Read after the break for more details and FDA warning.
Avandia increased heart attacks by 42 percent and doubled rates of heart failure, according to a report in the Sept. 13 Journal of the American Medical Association.
Takeda’s Actos reduced heart attacks, strokes and deaths by 18 percent, though it also increased heart failure, a separate study funded by the Takeda found.
Avandia was the world’s best-selling diabetes pill until May, when Cleveland Clinic researchers reported in the New England Journal of Medicine that it increased heart attack risks by 43 percent.
“Whatever statistical study you use, you find that rosiglitazone still increases the risks of heart attack and heart failure,” said Yoon Loke, a clinical pharmacologist at the University of East Anglia in Norwich, England, and a co-author of the Avandia study in JAMA.
Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
FDA’s analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug’s sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.
Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
The bottom line is if you are either on Avandia or Actos you should immediately consult with your healthcare provider. You may have risks either way but Avandia looks more dangerous at this time.