A study, published in the June 8 issue of the New England Journal of Medicine, involving 14,724 Type 2 diabetes patients with heart disease history showed that Merck & Co.'s Januvia drug does not increase one's risk of major heart failure. Januvia is an oral diabetes drug that helps control blood sugar levels by regulating the insulin produced by the body after eating.
Researchers at the University of Oxford Diabetes Trials Unit and the Duke University Clinical Research Institute found that only 11.4 percent of those who added Januvia to their treatment experienced heart-related death, heart attack and stroke during the three-year study period. However, this number is not considered statistically significant because 11.6 percent of those who had a placebo had the same experience. The finding of the study clears Januvia from being a contributor to heart failure concerns, reported Reuters.
"We've teased this data backwards and forwards and everything comes up looking like the drug does not have a cardiovascular safety signal," said study co-author Eric Peterson, of Duke University's cardiology department, during the press conference at the annual meeting of the American Diabetes Association in Boston.
The study also looked at other conditions—such as infections, cancer, kidney failure and severe hypoglycemia—that were previously linked to Januvia and saw no significant difference between those who took the drug and the placebo group. However, the researchers observed a higher number of cases of acute pancreatitis on the Januvia patients compared to the placebo patients.
"The rate is so low that it is not hugely interesting," Ethan J. Weiss, a cardiologist at UCSF, told Forbes.
Merck is expecting the study results will boost the sales of Januvia and give it a bigger advantage over its competitors, AstraZeneca's Onglyza and Takeda's Nesina. Bernstein Research forecasts Januvia's sales to reach $7.1 billion in three years.
