Merck Announces the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) Met Primary Endpoint


April 27, 2015 4:00 pm ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the Trial Evaluating Cardiovascular Outcomes with
Sitagliptin (TECOS) of Merck’s DPP-4 inhibitor, JANUVIA®
(sitagliptin), achieved its primary endpoint of non-inferiority for the
composite cardiovascular (CV) endpoint. Among secondary endpoints, there
was no increase in hospitalization for heart failure in the sitagliptin
group versus placebo. The complete results of TECOS will be presented on
June 8, 2015 at the 75th Scientific Sessions of the American
Diabetes Association.

The TECOS CV safety trial was led by an independent academic research
collaboration between the University of Oxford Diabetes Trials Unit
(DTU) and the Duke University Clinical Research Institute (DCRI).

Indications and Limitations of Use for JANUVIA®

JANUVIA is indicated, as an adjunct to diet and exercise, to improve
glycemic control in adults with type 2 diabetes mellitus. JANUVIA should
not be used in patients with type 1 diabetes or for the treatment of
diabetic ketoacidosis. JANUVIA has not been studied in patients with a
history of pancreatitis. It is unknown whether patients with a history
of pancreatitis are at increased risk of developing pancreatitis while
taking JANUVIA.

Selected Important Risk Information

JANUVIA is contraindicated in patients with a history of a serious
hypersensitivity reaction to sitagliptin, such as anaphylaxis or
angioedema. There have been postmarketing reports of acute pancreatitis,
including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in
patients taking JANUVIA. After initiating JANUVIA, observe patients
carefully for signs and symptoms of pancreatitis. If pancreatitis is
suspected, promptly discontinue JANUVIA and initiate appropriate

About the TECOS CV Safety Trial

TECOS was an event-driven trial conducted in adults with type 2 diabetes
and a history of cardiovascular disease. The study was designed to
assess the CV safety of long-term treatment with JANUVIA as part of
usual diabetes care compared with usual care without JANUVIA. The
primary endpoint was the composite of time to the first of any of the
following confirmed events: cardiovascular-related death, nonfatal
myocardial infarction, nonfatal stroke, or unstable angina requiring

TECOS enrolled 14,724 participants from 38 countries between December
2008 and July 2012. The median patient follow-up was approximately three

Selected important risk information about JANUVIA®
(sitagliptin) 25 mg, 50 mg and 100 mg tablets (continued)

Assessment of renal function is recommended prior to initiating JANUVIA
and periodically thereafter. A dosage adjustment is recommended in
patients with moderate or severe renal insufficiency and in patients
with end-stage renal disease requiring hemodialysis or peritoneal
dialysis. Caution should be used to ensure that the correct dose of
JANUVIA is prescribed.

There have been postmarketing reports of worsening renal function,
including acute renal failure, sometimes requiring dialysis. A subset of
these reports involved patients with renal insufficiency, some of whom
were prescribed inappropriate doses of sitagliptin.

When JANUVIA was used in combination with a
sulfonylurea or insulin, medications known to cause hypoglycemia, the
incidence of hypoglycemia was increased over that of placebo. Therefore,
a lower dose of sulfonylurea or insulin may be required to reduce the
risk of hypoglycemia.

The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2 percent (0.59 episodes per
patient-year) for JANUVIA 100 mg in combination with glimepiride (with
or without metformin), 1.8 percent (0.24 episodes per patient-year) for
placebo in combination with glimepiride (with or without metformin),
15.5 percent (1.06 episodes per patient-year) for JANUVIA (sitagliptin)
100 mg in combination with insulin (with or without metformin), and 7.8
percent (0.51 episodes per patient-year) for placebo in combination with
insulin (with or without metformin).

There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with JANUVIA® (sitagliptin),
such as anaphylaxis, angioedema and exfoliative skin conditions
including Stevens-Johnson syndrome. Onset of these reactions occurred
within the first 3 months after initiation of treatment with JANUVIA,
with some reports occurring after the first dose. If a hypersensitivity
reaction is suspected, discontinue JANUVIA, assess for other potential
causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other dipeptidyl peptidase-4
(DPP-4) inhibitors. Use caution in a patient with a history of
angioedema with another DPP-4 inhibitor because it is unknown whether
such patients will be predisposed to angioedema with JANUVIA.

There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with JANUVIA or with any other antidiabetic

In clinical studies, the adverse reactions reported, regardless of
investigator assessment of causality, in greater than or equal to 5
percent of patients treated with JANUVIA as monotherapy and in
combination therapy, and more commonly than in patients treated with
placebo, were upper respiratory tract infection, nasopharyngitis and

About Merck

Today’s Merck is a global health care leader working to help the world
be well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to health care through
far-reaching policies, programs and partnerships. For more information,
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Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These statements are based upon the
current beliefs and expectations of Merck’s management and are subject
to significant risks and uncertainties. If underlying assumptions prove
inaccurate or risks or uncertainties materialize, actual results may
differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise except as required by applicable law. Additional factors that
could cause results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2014 Annual Report on
Form 10-K and the company’s other filings with the Securities and
Exchange Commission (SEC) available at the SEC’s Internet site (

Please see Prescribing Information for JANUVIA®
(sitagliptin) at
and Medication Guide for JANUVIA at

Pam Eisele, 267-305-3558
Kim Hamilton, 908-740-1863
Joe Romanelli, 908-740-1986
Justin Holko, 908-740-1879

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