Researchers perform the most comprehensive evaluation of the cardiovascular risk of type 2 diabetes drug rosignlitazone ever completed.
A new study adds to evidence that rogsiglitazone, a drug used to treat type 2 diabetes (T2D), is associated with an increased risk of cardiovascular problems, such as heart failure. The study is the most comprehensive evaluation of the cardiovascular risk of rosignlitazone ever completed.
Rosiglitazone is part of a class of drugs called thiazolidinediones and was designed to control blood sugar levels in patients with T2D. However, it was also found to increase the risk of serious heart problems, leading to suspension of the drug in Europe and previous restrictions on its use in the United States.
A research team wanted to analyze raw clinical data from previous work and clarify some of the uncertainties surrounding rosiglitazone’s cardiovascular risk. The team examined the results of more than 130 trials that included over 48,000 adult patients that compared rosiglitazone with any control for at least 24 weeks. Individual patient data (IPD) were available for 33 trials, which included 21,156 patients, whereas the remaining trials only had summary level data available.
When the researchers analyzed the IPD from trials made available by GlaxoSmithKline (GSK), they found rosiglitazone was associated with a 33% increased risk of a composite cardiovascular event, or heart attack, heart failure, etc, compared with controls. This was estimated from 274 events among 11,837 rosiglitazone patients and 219 events among 9319 control patients.
When examining cardiovascular events independently, the analyses of the 33 GSK trials with IPD resulted in higher estimates of the risk of heart attacks than the analyses of trials with IPD and summary level data. These findings highlight the potential for different results derived from different data sources and demonstrate the need for greater clinical trial transparency and data sharing to accurately assess the safety of drugs, according to the study authors.
The findings suggest that when evaluating drug safety and performing meta-analyses focused on safety, IPD might be necessary to accurately classify all adverse events, the study authors concluded. Furthermore, by including these data in research, patients, clinicians, and investigators would be able to make more informed decisions about the safety of interventions.