A new study published by The BMJ adds to evidence that rosiglitazone – a drug used to treat type 2 diabetes – is associated with increased risk of heart problems, especially heart failure.
This study led by the Yale School of Public Health is the most comprehensive evaluation of the cardiovascular risk of rosiglitazone ever done. Rosiglitazone belongs to a class of drugs known as thiazolidinediones. While it was designed to control blood sugar levels in patients with type 2 diabetes, it can also increase the risk of serious heart problems. This has led to suspension of the drug in Europe and previous restrictions on its use in the United States.
“Since 2007, studies have reported conflicting findings about whether rosiglitazone increases the risk of heart attacks,” said Dr. Joshua Wallach, assistant professor at the Yale School of Public Health and the study’s lead author. “However, these studies did not have access to the raw data, also known as individual patient level data (IPD), from clinical trials, which are more reliable when estimating a drug’s true safety profile.”
Recent efforts by GlaxoSmithKline (GSK) – rosiglitazone’s manufacturer – to make IPD available to external investigators, prompted a team of U.S. researchers to analyze the raw clinical data and clarify some of the uncertainties surrounding rosiglitazone’s cardiovascular risk.
Dr. Wallach and co-authors analyzed the results of more than 130 trials involving over 48,000 adult patients that compared rosiglitazone with any control for at least 24 weeks. IPD were available for 33 trials, which included 21156 patients; the remaining trials only had summary level data available.Tags: Friday Letter Submission, Publish on February 21