A drug by the name of ‘rosiglitazone’ used to treat type 2 diabetes was found to be associated with increased risk of heart problems, especially heart failure. Findings were based on a comprehensive evaluation of the cardiovascular risk from rosiglitazone use.
Rosiglitazone belongs to a class of drugs known as thiazolidinediones that help target blood sugar levels in patients with type 2 diabetes, however, it can also increase the risk of heart complications. As a result, Rosiglitazone use was suspended in Europe and holds previous restrictions in the United States.
Researchers stated: "Our study highlights the need for independent evidence assessment to promote transparency and ensure confidence in approved therapeutics, and postmarket surveillance that tracks known and unknown risks and benefits."
But, since 2007, studies reported conflicting findings about whether rosiglitazone does lead to risky heart complications. These studies did not access raw data from patients and mostly were based on summary level data that was not to the highest reliability. The drug maker of rosiglitazone--GlaxoSmithKline (GSK)--has placed effort to make patient data available for investigators and thus prompted researchers to re-analyze uncertainty about the role of the drug in cardiovascular risk.
"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," noted the researchers. "By including these data in research, patients, clinicians, and researchers would be able to make more informed decisions about the safety of interventions."
Source: Science Daily