The U.S. Food and Drug Administration (FDA) is examining data from two clinical trials to determine whether Benicar, a blood pressure medicine, increases the risk of heart-related deaths in Type 2 diabetic patients, according to a recent article from Reuters.
The agency posted a notice Friday indicating that it has not yet reached a conclusion and saying that it believes the benefits of the drug from Daiichi Sankyo still outweigh the risks.
In the trials, people with Type 2 diabetes were given Benicar or a placebo. The goal was to determine whether the drug slows the progression of diabetes or kidney disease. In the larger of the two trials, data indicates that the drug does, in fact, slow the development of kidney disease.
However, researchers also found in both trials that the group given the drug also experienced a greater number of deaths from heart attack, stroke or sudden death when compared to patients given the placebo. In the larger study of about 4,400 patients, there were about 15-heart related deaths in the Benicar group versus three deaths in the placebo group. In the smaller study, which had 557 patients, there were 10 heart-related deaths among the group taking Benicar vesus three deaths in the placebo group.
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