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Merck Sharp and Dohme study shows cardiovascular safety of diabetes drug
Merck Sharp and Dohme has reported positive findings from a clinical study of the cardiovascular health profile of its type 2 diabetes drug Januvia.
The placebo-controlled TECOS CV study assessed the cardiovascular safety of Merck's DPP-4 inhibitor therapy when added to usual care in more than 14,000 patients. It met its primary endpoint of non-inferiority compared to usual care without Januvia.
In addition, there was no increase in hospitalization for heart failure and rates of all-cause mortality were similar in both treatment groups, which were two key secondary endpoints of the study.
Dr Roger Perlmutter, president of Merck Research Laboratories, said: "The TECOS CV safety trial reflects the best efforts of clinical scientists at the University of Oxford, the Duke Clinical Research Institute and Merck on behalf of patients around the world who suffer from type 2 diabetes."
Januvia is contraindicated in patients with a history of a serious hypersensitivity reaction to its active ingredient sitagliptin. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Januvia or with any other antidiabetic drug.
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