A new study conducted by Yale School of Public Health finds that Rosiglitazone (Avandia), a drug developed to treat type 2 diabetes, increases the risk of heart attack, heart failure, cardiovascular deaths, and non-cardiovascular-related deaths by 33%.
The Yale-based team sought to vet and analyze over 130 randomized, phase II-IV clinical trials. As opposed to previous research into the risks of this compound, the researchers secured access to individual patient data (IPD)—the raw data associated with a patient in a study such as medical records—for 33 of the trials. This equaled the amount of 48,000 adult patient data—researchers had IPD for 21,156. These studies involved the efficacy, safety, and comparison of the effects of rosiglitazone, and any other control, for at least six months.
The research team conveyed that the actual control group involved any drug combination besides rosiglitazone—including placebo. With access to this richer, more granular data, the team studied evidence of “acute myocardial infarction, heart failure, cardiovascular-related death, and non-cardiovascular-related death” in their assessment of the clinical trials where they had IPD. In trials with no IPD, they studied myocardial infarction and cardiovascular-related death using summary-level data.
The Yale team’s research produced significant insight into the risk of rosiglitazone, evidencing a 33% greater risk of heart attack, heart failure, cardiovascular deaths, and non-cardiovascular-related deaths combined for people who were taking the drug compared with people who were taking another control substance, including placebo.
Implications of Study: IPD
The researchers also suggest that when studying and assessing the safety of a drug, the importance of raw data cannot be overlooked. They noted, “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”.
Joshua Wallach, Department of Environmental Health Sciences, Yale School of Public HealthSource: thebmj