In a new study, researchers found new evidence that rosiglitazone—a drug used to treat type 2 diabetes—is associated with an increased risk of heart problems, especially heart failure.
This study is the most comprehensive evaluation of the heart risk of rosiglitazone ever done.
The research was conducted by a team at Yale School of Public Health and elsewhere.
Rosiglitazone belongs to a class of drugs called thiazolidinediones. It helps control blood sugar levels in patients with type 2 diabetes, but it can also increase the risk of serious heart problems.
This has led to a suspension of the drug in Europe and previous restrictions on its use in the United States.
However, since 2007, studies have reported conflicting findings of whether rosiglitazone increases the risk of heart attacks.
But these studies didn’t have access to individual patient-level data and are not as reliable when estimating the true safety profile of drugs.
In the new study, the team analyzed the results of more than 130 trials involving over 48,000 adult patients that compared rosiglitazone with any control for at least 24 weeks.
They found rosiglitazone was linked to 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.
The team says these findings highlight the potential for different results derived from different data sources.
They also demonstrate the need for greater clinical trial transparency and data sharing to accurately assess the safety of drugs.
The study is published in the BMJ.
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