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Recent studies show that diabetes drugs are connected to the increase in heart disease patients.
FREMONT, CA: A recent study, published by The BMJ, shows that rosiglitazone, the drug used for the treatment of type 2 diabetes, can be connected with an increased risk of heart diseases, particularly heart failure. The rosiglitazone belongs to a type of drug known as the thiazolidinediones. This drug helps the patients with type 2 diabetes to keep the blood sugar level in control, but it will affect the heart and increase the risk of severe heart issues. Therefore, in many countries like Europe, this drug has been suspended, and few like the United States have implemented restrictions on the use of the drug.
However, since the year 2007, some studies were conducted where there were few conflicting findings of the rosiglitazone, whether they increase the risk of disease-related to heart. However, the study did not have any access to the raw data, which is also known as the individual patient-level data (IPD) from the clinical trials. Instead, it was dependent on the summary level data. While evaluating the safety profile of a drug, the doctors cannot rely much on the summary level data.
The maker of rosiglitazone GlaxoSmithKline (GSK) made efforts so that external investigators get access to the IPD. They even encouraged a team of researchers from the US to re-analyze the data so that they can make precise statements about the uncertainties of cardiovascular risks caused by rosiglitazone.
Furthermore, while independently inspecting the cardiovascular events caused by rosiglitazone, it was realized that the analysis conducted by GSK with trials having IPD had higher risks of heart attacks than the study of trails done with IPD and summary level data. Therefore, the results highlighted the potential of different effects that can be extracted from several data sources and increases the necessity of transparency of clinical trials.
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