Good news for diebetes patient

THE MSD's Cardiovascular Safety Trial of
JANUVIA (sitagliptin), Met Primary
Endpoint in Patients with Type 2 Diabetes
TECOS study showed that treatment with
Sitagliptin does not increase the risks of
Major cardiovascular events or
hospitalisation for heart failure
MSD, known as Merck in the United States
and Canada, recently announced the primary
results of the Trial Evaluating Cardiovascular
Outcomes with Sitagliptin (TECOS), a
placebo-controlled study of the
cardiovascular (CV) safety of MSD's DPP-4
inhibitor, JANUVIA (sitagliptin).
The TECOS cardiovascular safety trial was an
event-driven study designed to assess the
long-term CV safety of the addition of
sitagliptin to usual care, compared to usual
care without sitagliptin, in patients with type
2 diabetes and established CV disease.
The study enrolled more than 14,735 patients
from 38 countries and was led by
independent academic research collaboration
between the University of Oxford Diabetes
Trials Unit and the Duke University Clinical
Research Institute, and was sponsored by
MSD.
Among the key findings, it was evident that
there was no increase in CV-related deaths or
hospitalization for heart failure in the
Sitagliptin group versus placebo.
"Patients with type 2 diabetes need
antihyperglycemic medicines to help control
their blood sugar. Because these patients are
at increased risk for cardiovascular
complications, understanding the
cardiovascular safety of these medicines is
important," said study co-chair Rury Holman,
Professor of Diabetic Medicine and Diabetes
Trials Unit Director, University of Oxford.
"The results from TECOS showed that
sitagliptin did not increase the risk of
cardiovascular events in a diverse group of
patients with type 2 diabetes at high
cardiovascular risk."
Overall, the primary endpoint occurred in
11.4 per cent (n=839) of sitagliptin-treated
patients compared with 11.6 per cent (n=851)
of placebo-treated patients in the Intention-
to-Treat (ITT) analysis, and in 9.6 per cent
(n=695) of patients in both the sitagliptin and
placebo groups in the Per Protocol (PP)
analysis.
In addition, there was no increase in
hospitalisation for heart failure, and rates of
all-cause mortality were similar in both
treatment groups, which were two key
secondary endpoints.
"We believe the results of TECOS provide
important clinical information about the
cardiovascular safety profile of sitagliptin,"
said Dr. Roger M. Perlmutter, president,
Merck Research Laboratories.
"The TECOS CV safety trial reflects the best
efforts of clinical scientists at the University
of Oxford, the Duke Clinical Research
Institute and MSD on behalf of patients
around the world who suffer from type 2
diabetes."