Avandia Riskier for Elderly, Canadian Study SaysAug 19, 2009 | Parker Waichman LLP
The diabetes drug Avandia carries more risk than Actos, a new study conducted by Canadian researchers has found. According to a Reuters report, seniors in the study taking Avandia were more likely to suffer from heart failure, and were more likely to die. The findings prompted the authors of the study to question the continuing use of Avandia.
According to Reuters, researchers at Sunnybrook Health Sciences Centre in Toronto analyzed six years of records for nearly 40,000 patients aged 66 years and older. They found that for every 93 patients given Avandia rather than Actos there would be one additional cardiovascular event or death each year. No significant difference in the risk of heart attack between Avandia and Actos was found.
"Given the accumulating evidence of harm with rosiglitazone (Avandia) treatment and the lack of a distinct clinical advantage for the drug over pioglitazone (Actos), it is reasonable to question whether ongoing use of rosiglitazone is justified," the study authors wrote in the British Medical Journal.
Avandia’s cardiovascular side effects first became the subject of concern in May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.
Avandia has been focus of other safety concerns. In July we reported that a prominent consumer advocacy group had found that Avandia had been associated with death as a result of liver failure, and should be banned by the FDA. The group, Public Citizen, published the research in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety. According to Public Citizen, it petitioned the FDA to ban Avandia as far back as October due to its risks, including heart attack, heart failure, and liver toxicity, noting that these risks “far outweigh its benefits,” especially given that there are safer medical alternatives for the treatment of Type 2 diabetes. The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia use, said Public Citizen.
In June, we wrote about a published Avandia study that found the drug “significantly” raises the risk of heart failure and fractures. Unlike previous research, the study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. According to a report on WebMD, the study—known as RECORD—caused some controversy because GlaxoSmithKline funded it.