Research out of the Yale School of Public Health in New Haven, Conn., has revealed a relationship between rosiglitazone, a type 2 diabetes drug, and heart disease.
Joshua Wallach, PhD, MS, et al.’s BMJ study is just the latest to contribute evidence to a growing case against rosiglitazone. The medication, which belongs to the thiazolidinedione drug class and was designed to control blood glucose, has been suspended in Europe and restricted in the U.S. because of links to serious heart problems.
“Since 2007, studies have reported conflicting findings about whether rosiglitazone increases the risk of heart attacks,” Wallach said in a release. “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.”
He said his team launched their study in response to recent efforts by rosiglitazone manufacturer GlaxoSmithKline to make IPD available to external investigators.
Wallach and co-authors scrutinized the results of over 130 trials that compared rosiglitazone with a control therapy for at least 24 weeks. A total of 48,000 patients were involved in the trials; IPD were available for 21,156, but the remaining trials could only offer summary-level data.
Estimating cardiovascular risk from 274 events in 11,837 rosiglitazone patients and 219 events in 9,319 control patients, the team found that rosiglitazone was associated with a 33% increased risk for major CV events including heart failure, MI and cardiovascular- and non-cardiovascular-related death. Independent analyses of the 33 trials with IPD data found higher estimates of MI risk than analyses of trials with both IPD and summary-level data, suggesting the authors’ results differed significantly based on their data source.
Wallach et al. said their findings demonstrate the need for improved clinical transparency and data sharing so that we can accurately assess the safety of individual drugs. They also said that IPD “might be necessary to accurately classify all adverse events.”
“Although rosiglitazone is no longer available in Europe, and now rarely prescribed in the U.S., the rosiglitazone story is an important lesson in the value of clinical transparency,” Wallach said. “Our study demonstrates how data-sharing platforms can be used to improve our understanding of drug safety.”