A new study by the Yale School of Public Health, published by The BMJ, suggests that there is evidence that the diabetes drug, rosiglitazone, is linked to an increased risk of cardiovascular issues.
Rosiglitazone was meant to help patients with Type II Diabetes control their blood sugar, but it has also had a reputation as a drug with cardiovascular risks. According to the study’s lead author and assistant professor, Joshua Wallach, “Since 2007, studies have reported conflicting findings about whether rosiglitazone increases the risk of heart attacks. 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.”
When GlaxoSmithKline (manufacturer of rosiglitazone) made the IPD available to those external to the company, Wallach and the other researchers examined the results of more than 130 clinical trials, which included more than 48,000 patients. All the patients evaluated were adults, and they had been evaluated on rosiglitazone for a period of 24 weeks and compared to a control.
Wallach’s team found that there was a 33% increased risk of heart attack, heart failure, and cardiovascular disease in patients who were prescribed rosiglitazone.
While rosiglitazone has been pulled from the European market and is now rarely prescribed in the United States, the danger it posed while available was made possible by the initial lack of IPD. The researchers stated, "Our study suggests that when evaluating drug safety and performing meta-analyses focused on safety, IPD might be necessary to accurately classify all adverse events," the researchers said.
According to Wallach, "Our study demonstrates how data-sharing platforms can be used to improve our understanding of drug safety."