Acute Cardiovascular Care 2020 will highlight novel research on recovery from heart emergencies
When the researchers analyzed the IPD from trials made available by GSK, they found rosiglitazone was associated with a 33% increased risk of a composite cardiovascular event (heart attack, heart failure, cardiovascular and non-cardiovascular related death) compared with controls. This was estimated from the 274 events among 11,837 rosiglitazone patients and 219 events among 9,319 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, the researchers said.
"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.
"By including these data in research, patients, clinicians, and researchers would be able to make more informed decisions about the safety of interventions."
"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 trial transparency" said Wallach. "Our study demonstrates how data-sharing platforms can be used to improve our understanding of drug safety." Source:
Yale School of Public Health Journal reference:
Wallach, J.D., et al. (2020) Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. BMJ . doi.org/10.1136/bmj.l7078 .
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