Diabetes drug may compromise cardiovascular health
Rosiglitazone is a drug originally developed to treat type 2 diabetes.
ISLAMABAD (Online) - New research uses high quality data to find that the type 2 diabetes drug rosiglitazone raises the risk of adverse cardiovascular events by 33%.
Rosiglitazone is a drug originally developed to treat type 2 diabetes. The United States Food and Drug Administration (FDA) approved it in 1999 under the name Avandia.
Although Europe suspended the drug due to concerns about its adverse effects on heart health, and the United States restricted its use, the research on its safety has so far yielded mixed results.
Now, a new study, appearing in the journal The BMJ has used more reliable data to investigate the effects of this drug on cardiovascular health.
Joshua D. Wallach, who is an assistant professor in the Department of Environmental Health Sciences at Yale School of Public Health in New Haven, CT, is the lead author of the new paper.
The FDA approved rosiglitazone in 1999, a year ahead of Europe, note Wallach and colleagues in their paper.
Regulatory bodies warned about its potential effects on heart failure as early as 2006, and a meta-analysis of several trials pointed to a 43% higher risk of heart attack in 2007.
As a result, by 2010, the drug was pulled off European markets because it raised the risk of heart attack and stroke.
In the U.S., the drug is still available, although it features warnings on its packaging, and the FDA restricted its availability in 2010-2011.
The fact that the drug is still available is primarily due to the mixed results yielded by the investigation into the drug’s cardiovascular effects.
However, the new research suggests that these mixed results are due to the poor quality of the data that these previous studies used.
Namely, these previous papers did not have access to “individual patient data (IPD),” that is, raw data, such as the medical records of patients, instead of summary-level data, which are the final results of clinical trials, for example.
