Results from a new study reaffirm evidence that rosiglitazone, a type 2 diabetes drug, may be associated with an increased risk of cardiovascular (CV) problems.
Rosiglitazone, which belongs to a class of drugs called thiazolidinediones, is indicated to help control blood sugar levels in patients with type 2 diabetes; however, studies dating back to 2007 have suggested that the drug may have unwanted effects on CV health.
The study, published in BMJ, is the most comprehensive systematic review and meta-analysis of the CV risk of rosiglitazone.
The analysis included phase 3/phase 4 clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults. The researchers used individual patient level data (IPD) made available by GlaxoSmithKline (GSK) to examine a composite outcome of acute myocardial infarction, heart failure (HF), CV-related death, and non CV-related death. For studies in which IPD were not available, myocardial infarction and CV-related death were examined, which were determined by summary level data.
A total of 33 eligible trials for which IPD were available, involving 21,156 patients, were included. An additional 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction and CV-related death.
According to results from the analyses with IPD, rosiglitazone was associated with a 33% increased risk of a composite CV event compared with control. There were 274 events among 11,837 patients treated with rosiglitazone and 219 events among 9319 patients in the control group.
Additionally, the researchers found that the analyses of 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.
“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 wrote. “By including these data in research, patients, clinicians, and researchers would be able to make more informed decisions about the safety of interventions.”
1. Wallach JD, Wang K, Zhang AD, et al. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. BMJ. 2020. doi: https://doi.org/10.1136/bmj.l7078