|
 Merck in April said the study, called Tecos, of 14,724 patients with
type 2 diabetes and a history of heart disease demonstrated that
adding Januvia to usual care did not increase major heart problems
any more than adding a placebo, removing a cloud that has been
holding back sales of the medicine and the company's share price.
Januvia, an oral medication known chemically as sitagliptin that
helps lower blood sugar levels, had sales of about $4 billion in
2014, plus another $1.8 billion for the related combination product
Janumet
On the study's main focus, after about three years 11.4 percent of
Januvia patients had experienced cardiovascular death, non-fatal
heart attack, non-fatal stroke or hospitalization for unstable
angina versus 11.6 percent in the placebo group.
The detailed results also showed no increase in hospitalization for
heart failure, which had been a particular concern with DPP-4
inhibitors, the class to which Januvia belongs. There were 228 such
hospitalizations for Januvia and 229 in the placebo group, according
to data also published in the New England Journal of Medicine.
"We can be reassured we can use this drug for glucose lowering
without affecting the already high cardiovascular risk in people
with type 2 diabetes," said Professor Rury Holman, the study's lead
investigator, who presented the data at the American Diabetes
Association meeting in Boston.
"For the heart failure concern raised by other agents in the class
there is no difference (with placebo)," he added.
There was also no significant difference between Januvia and placebo
in infections, cancer, kidney failure or severe hypoglycemia, which
is dangerously low blood sugar, researchers reported.
[to top of second column] |
Acute pancreatitis, a concern with some diabetes drugs, was uncommon
but higher with Januvia, 23 versus 12. That was not statistically
significant.
"Numerically this is hardly a major risk, just something we need to
keep an eye on," Holman said.
Pancreatic cancers, also uncommon, were numerically fewer with
Januvia, 9 versus 14.
Death from any cause occurred in 7.5 percent of Januvia patients
versus 7.3 percent for placebo.
The Tecos heart safety study was conducted by an independent
academic research collaboration between the University of Oxford
Diabetes Trials Unit and the Duke University Clinical Research
Institute. It was undertaken after heart safety concerns were raised
over other diabetes medicines.
(Reporting by Bill Berkrot; Editing by Leslie Adler)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
