In a recent study from Yale School of Public Health and other institutions, scientists found that the diabetes drug rosiglitazone is associated with an increased risk of heart problems, particularly heart failure.
Rosiglitazone belongs to a class of drugs called thiazolidinediones. It is used to control blood sugar levels in patients with type 2 diabetes, but it has also been linked to an increased risk of serious heart problems.
These findings have led to suspending the drug in Europe and previous restrictions on its use in the United States.
However, since 2007, studies have reported conflicting findings on whether rosiglitazone increases the risk of heart attacks.
These studies did not have access to individual patient-level data, making them less reliable when estimating the true safety profile of drugs.
The current study represents the most comprehensive evaluation of rosiglitazone’s heart risk.
Researchers analyzed the results of over 130 trials involving more than 48,000 adult patients, comparing rosiglitazone with any control for at least 24 weeks.
Findings
The study found that rosiglitazone was associated with a 33% increased risk of a composite cardiovascular event (including heart attack, heart failure, and cardiovascular and non-cardiovascular-related death) compared to controls.
This estimate was derived from 274 events among 11,837 rosiglitazone patients and 219 events among 9,319 control patients.
The researchers noted that these findings underscore the potential for different results based on different data sources.
They also stressed the need for greater clinical trial transparency and data sharing to assess the safety of drugs accurately.
This research indicates that the diabetes drug rosiglitazone may pose a significant heart risk, especially in terms of heart failure.
The study highlights the importance of comprehensive and transparent data analysis in determining the safety profile of drugs.
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The research was published in the British Medical Journal (BMJ).
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